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PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00340704
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder, Neurogenic
Intervention Drug: tamsulosin hydrochloride
Enrollment 143
Recruitment Details This trial has 3 different Data base locks (DBLs) based on 3 separate populations PK/PD, Group D-Denovo & Group D-527.51 Rollover. For population PK/PD the DBL date was 18July2007, Group D-Denovo the DBL date was 23Jan2009 & Group D-527.51 Rollover the DBL date was 11Sep2009.
Pre-assignment Details Three different Clinical trial reports were prepared based on 3 separate populations (PK/PD, Group D-Denovo & Group D-527.51). Group D-Denovo includes patients from PK Phase & additional subjects & Group D-527.51 Rollover includes patients who successfully completed tamsulosin HCl Study 527.51
Arm/Group Title Tamsulosin - Low Dose Level (PK Study) Tamsulosin - Medium Dose Level (PK Study) Tamsulosin - High Dose Level (PK Study) Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.

In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Period Title: PK Study
Started 10 10 11 0 0 0 0 0 0
Completed 10 9 10 0 0 0 0 0 0
Not Completed 0 1 1 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0             0             0             0             0
Not treated             0             0             1             0             0             0             0             0             0
Period Title: Group D- Denovo & 527.51 Rollover Study
Started 0 0 0 29 21 37 54 13 29
PK Study Subjects Entered Group D-Denovo 0 0 0 7 5 18 0 0 0
Completed 0 0 0 27 16 30 1 1 0
Not Completed 0 0 0 2 5 7 53 12 29
Reason Not Completed
Adverse Event             0             0             0             2             4             0             0             1             1
Protocol Violation             0             0             0             0             0             1             0             0             0
Withdrawal by Subject             0             0             0             0             1             3             0             0             0
Other reason not defined above             0             0             0             0             0             3             53             11             28
Arm/Group Title Tamsulosin - Low Dose Level (PK Study) Tamsulosin - Medium Dose Level (PK Study) Tamsulosin - High Dose Level (PK Study) Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover) Total
Hide Arm/Group Description Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 22 16 19 54 13 29 183
Hide Baseline Analysis Population Description
Treated Set: Includes all patients who are dispensed study medication and are documented to have taken at least one dose of treatment. In this study, some of the subjects are in multiple phases: PK and Group D-Denovo. Thus, the baseline characteristics are based on the unique subject entered into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 22 participants 16 participants 19 participants 54 participants 13 participants 29 participants 183 participants
8.7  (4.5) 6.5  (2.6) 8.8  (3.7) 6.8  (3.4) 6.3  (3.7) 8.1  (3.8) 8.1  (3.8) 7.0  (3.4) 8.3  (4.1) 7.7  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 22 participants 16 participants 19 participants 54 participants 13 participants 29 participants 183 participants
Female
5
  50.0%
3
  30.0%
5
  50.0%
12
  54.5%
7
  43.8%
10
  52.6%
21
  38.9%
8
  61.5%
12
  41.4%
83
  45.4%
Male
5
  50.0%
7
  70.0%
5
  50.0%
10
  45.5%
9
  56.3%
9
  47.4%
33
  61.1%
5
  38.5%
17
  58.6%
100
  54.6%
1.Primary Outcome
Title Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover
Hide Description Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure <40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
Time Frame Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-LPP): This subject set includes all subjects in the Treated set who received one dose of treatment and had one on treatment LPP measurement.
Arm/Group Title Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 26 14 30 53 12 29
Measure Type: Number
Unit of Measure: percentage of responders
73.1 35.7 26.7 67.9 58.3 20.7
2.Primary Outcome
Title Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.
Hide Description Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
Time Frame Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-LPP)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 53 12 29
Measure Type: Number
Unit of Measure: Participants
Week 1 (N= 40 (LD), 12 (MD), 27 (HD)) 38 1 0
Week 2 (N= 2 (LD), 7 (MD), 27 (HD)) 2 7 2
Week 3 (N= 3 (LD), 0 (MD), 22 (HD)) 2 0 5
Week 4 (N= 1 (LD), 0 (MD), 3 (HD)) 1 0 0
Week 9 (N= 7 (LD), 2 (MD), 16 (HD)) 5 2 5
Week 13 (N= 4 (LD), 0 (MD), 2 (HD)) 1 0 1
Week 26 (N= 2 (LD), 0 (MD), 3 (HD)) 1 0 1
Week 52 (N= 1 (LD), 1 (MD), 0 (HD)) 1 1 0
3.Secondary Outcome
Title Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover
Hide Description Early responders who maintained their detrusor leak point pressure (LPP) below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2,3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was not analysed for Group D-527.51 Rollover as very limited data were collected due to early termination of the study & no alternative endpoint was defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided.
Time Frame Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).
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Hide Analysis Population Description
Full analysis set (FAS-LPP)
Arm/Group Title Tamsulosin-low Dose Level (Group D-Denovo) Tamsulosin-medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 28 21 37 0 0 0
Measure Type: Number
Unit of Measure: Participants
17 5 3
4.Secondary Outcome
Title Change From Baseline in LPP for Group D-527.51 Rollover
Hide Description Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
Time Frame Baseline and week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-LPP)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 53 12 29
Median (Standard Deviation)
Unit of Measure: cm H2O
Baseline (N= 53 (LD), 12 (MD), 29(HD)) 48.50  (14.47) 48.5  (11.19) 55.50  (24.52)
Week 1 - Actual (N= 39 (LD), 9 (MD),22 (HD)) 29.00  (8.50) 49.50  (8.30) 64.75  (27.20)
Week 1 - Change (N= 39 (LD), 9 (MD),22 (HD)) -25.5  (15.18) -2  (13.68) -1.25  (24.97)
5.Secondary Outcome
Title Percent Change From Baseline in LPP for Group D-527.51 Rollover
Hide Description Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
Time Frame Baseline and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-LPP)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 53 12 29
Median (Standard Deviation)
Unit of Measure: percent change
Baseline (N= 53 (LD), 12 (MD), 29 (HD)) 48.50  (14.47) 48.50  (11.19) 55.50  (24.52)
Week 1 - Actual (N= 39 (LD), 9 (MD), 22 (HD)) 29.00  (8.50) 49.50  (8.30) 64.75  (27.20)
Week 1 - Change (N= 39 (LD), 9 (MD), 22 (HD)) -48.48  (18.65) -3.88  (22.43) -2.71  (40.41)
6.Secondary Outcome
Title Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
Hide Description Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in the Group D-527.51 Rollover. Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at end of treatment compared to baseline. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
Time Frame Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-RENAL): Includes all patients in the Treated set who received one dose of treatment and had one on treatment renal measurement.
Arm/Group Title Tamsulosin-low Dose Level (Group D-Denovo) Tamsulosin-medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 27 17 34 44 8 19
Measure Type: Number
Unit of Measure: Participants
Right Kidney 26 15 28 43 8 19
Left Kidney 24 14 29 43 8 17
7.Secondary Outcome
Title Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
Hide Description Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment) at week 52 for Group D-Denovo and (subjects are classified according to the treatment they were taking at the end of treatment) at last value on treatment for Group D-527.51 Rollover. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 Rollover. Hydronephrosis response is defined as an improvement or stabilization based upon ultrasound grading at the end of the study. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization.
Time Frame Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-RENAL). This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
Arm/Group Title Tamsulosin-low Dose Level (Group D-Denovo) Tamsulosin-medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 27 17 34 44 8 19
Measure Type: Number
Unit of Measure: Participants
Right Kidney 26 15 28 39 8 17
Left Kidney 24 14 26 42 7 17
8.Secondary Outcome
Title LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover
Hide Description Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
Time Frame Week 1 to Week 52 (described study wise in the Description).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS-LPP)
Arm/Group Title Tamsulosin-low Dose Level (Group D-Denovo) Tamsulosin-medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 28 21 37 53 12 29
Measure Type: Number
Unit of Measure: participants
26 16 16 42 8 12
9.Secondary Outcome
Title Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover
Hide Description Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
Time Frame From first drug administration until 28 days after last study drug administration, upto 395 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 54 13 29
Measure Type: Number
Unit of Measure: Participants
1 0 0
10.Secondary Outcome
Title Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo
Hide Description Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided.
Time Frame From first drug administration until 28 days after last study drug administration, upto 450 days
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Hide Analysis Population Description
Treated Set (TS)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 29 21 37
Measure Type: Number
Unit of Measure: Participants
Blood urine present 0 0 1
Body temperature increased 0 0 1
Orthostatic hypotension 1 3 0
11.Secondary Outcome
Title Vision Testing for Group D-Denovo
Hide Description Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided.
Time Frame Baseline, Week 26 and Week 52.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo)
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 29 21 37
Measure Type: Number
Unit of Measure: Participants
Right Eye (Week 26) - No Change 11 7 12
Right Eye (Week 26) - Decrease in visual acuity 8 1 8
Right Eye (Week 26) - Increase in visual acuity 8 4 11
Right Eye (Week 26) - Missing 2 9 6
Left Eye (Week 26) - No Change 11 6 19
Left Eye (Week 26) - Decrease in visual acuity 7 1 4
Left Eye (Week 26) - Increase in visual acuity 9 5 8
Left Eye (Week 26) - Missing 2 9 6
Right Eye (Week 52) - No Change 7 6 16
Right Eye (Week 52) - Decrease in visual acuity 10 2 4
Right Eye (Week 52) - Increase in visual acuity 11 6 12
Right Eye (Week 52) - Missing 1 7 5
Left Eye (Week 52) - No Change 11 5 12
Left Eye (Week 52) - Decrease in visual acuity 6 3 6
Left Eye (Week 52) - Increase in visual acuity 11 7 14
Left Eye (Week 52) - Missing 1 6 5
12.Secondary Outcome
Title Vision Testing for Group D-527.51 Rollover
Hide Description Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing. Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS)
Arm/Group Title Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description:

Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.

In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.

Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 54 13 29
Measure Type: Number
Unit of Measure: Participants
Right Eye - No Change 32 10 12
Right Eye - Decrease in visual acuity 5 2 4
Right Eye - Increase in visual acuity 12 1 6
Right Eye - Missing 5 0 7
Left Eye - No Change 31 12 12
Left Eye - Decrease in visual acuity 8 1 3
Left Eye - Increase in visual acuity 10 0 7
Left Eye - Missing 5 0 7
13.Secondary Outcome
Title Cmax,1
Hide Description Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics single dose set (PK-SD): This set includes subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK at Visit 2.
Arm/Group Title PK Study - Single Dose
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 - 25.0 kg, 25.1 - 50.0 kg and 50.1 - 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose.

Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1.67
(68.80%)
14.Secondary Outcome
Title Tmax, 1
Hide Description Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics single dose set (PK-SD)
Arm/Group Title PK Study - Single Dose
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 - 25.0 kg, 25.1 - 50.0 kg and 50.1 - 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose.

Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: hours
6
(2 to 8)
15.Secondary Outcome
Title Cmax, 1 ,DW ,Norm
Hide Description Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics single dose set (PK-SD)
Arm/Group Title PK Study - Single Dose
Hide Arm/Group Description:

Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 - 25.0 kg, 25.1 - 50.0 kg and 50.1 - 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose.

Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL/mg*kg
1120
(67.20%)
16.Secondary Outcome
Title Cpre,ss
Hide Description Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS): This set includes subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit.
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 9 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
0.914
(159%)
1.83
(131%)
4.03
(70.60%)
17.Secondary Outcome
Title Cmax,ss
Hide Description Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
2.79
(59.50%)
5.02
(94.80%)
14.10
(50.30%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamsulosin - Low Dose Level (Steady State - PK Study), Tamsulosin - Medium Dose Level (Steady State - PK Study), Tamsulosin - High Dose Level (Steady State - PK Study)
Comments Dose proportionality for Cmax,ss was explored based on the regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 1.0039
Confidence Interval 95%
0.6499 to 1.3579
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1725
Estimation Comments Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.
18.Secondary Outcome
Title Cmax,ss, DW, Norm
Hide Description Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL/mg*kg
2040
(74.30%)
1850
(85.70%)
2240
(47.60%)
19.Secondary Outcome
Title Cmin,ss
Hide Description Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
0.747
(99.70%)
1.52
(130%)
4.01
(68.50%)
20.Secondary Outcome
Title Tmax,ss
Hide Description Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Median (Full Range)
Unit of Measure: hours
5.00
(2.33 to 8.00)
5.92
(2.00 to 8.00)
5.01
(2.23 to 8.00)
21.Secondary Outcome
Title AUCτ,ss
Hide Description Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
35.80
(75.60%)
68.20
(94.70%)
175.00
(61.00%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamsulosin - Low Dose Level (Steady State - PK Study), Tamsulosin - Medium Dose Level (Steady State - PK Study), Tamsulosin - High Dose Level (Steady State - PK Study)
Comments Dose proportionality for AUCτ,ss was explored based on the regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.98
Confidence Interval 95%
0.5934 to 1.3666
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1884
Estimation Comments Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.
22.Secondary Outcome
Title AUCτ ,ss ,DW ,Norm
Hide Description Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL/mg*kg
26100
(91.10%)
25200
(82.90%)
27700
(59.10%)
23.Secondary Outcome
Title λz,ss
Hide Description Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hours
0.0589
(48.10%)
0.0671
(40.80%)
0.0496
(31.90%)
24.Secondary Outcome
Title t1/2,ss
Hide Description Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
11.80
(48.10%)
10.30
(40.80%)
14.00
(31.90%)
25.Secondary Outcome
Title MRTpo,ss
Hide Description Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
18.70
(50.50%)
17.60
(35.00%)
20.90
(23.60%)
26.Secondary Outcome
Title CL/F,ss,W,Norm
Hide Description Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h/kg
0.0383
(91.10%)
0.0397
(82.90%)
0.0361
(59.10%)
27.Secondary Outcome
Title Vz/F,ss,W,Norm
Hide Description Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
Overall Number of Participants Analyzed 10 9 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/kg
0.65
(83.80%)
0.591
(103.00%)
0.729
(96.00%)
28.Secondary Outcome
Title RA,Cmax
Hide Description The accumulation ratio was calculated from the patients who were randomised to the low dose group and for whom both parameters at first dose and steady state dose were available. Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as: Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided.
Time Frame -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics steady state set (PK-SS)
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study)
Hide Arm/Group Description:

Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.

In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.

Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

Overall Number of Participants Analyzed 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
1.58
(65.20%)
Time Frame From first drug administration until 28 days after last study drug administration, upto 80 days (Steady State - PK study), upto 450 days (Group D-Denovo) and upto 395 days (Group D-527.51 Rollover).
Adverse Event Reporting Description Subjects were titrated to their efficacious dose.Based on LPP results,subjects could remain on that dose if it was found to be efficacious or titrate up to their higher doses which might have provided some efficacy.Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
 
Arm/Group Title Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study) Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Hide Arm/Group Description Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
All-Cause Mortality
Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study) Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study) Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   1/10 (10.00%)   0/10 (0.00%)   2/82 (2.44%)   3/61 (4.92%)   4/41 (9.76%)   1/93 (1.08%)   1/41 (2.44%)   1/29 (3.45%) 
Congenital, familial and genetic disorders                   
Tibial torsion  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  1/41 (2.44%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Gastrointestinal disorders                   
Peritoneal cyst  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/82 (1.22%)  0/61 (0.00%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Infections and infestations                   
Cellulitis  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  1/41 (2.44%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Dengue fever  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  1/61 (1.64%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Gastroenteritis  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  0/41 (0.00%)  0/93 (0.00%)  1/41 (2.44%)  0/29 (0.00%) 
Pneumonia  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  0/41 (0.00%)  1/93 (1.08%)  0/41 (0.00%)  0/29 (0.00%) 
Urinary tract infection  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  2/41 (4.88%)  0/93 (0.00%)  1/41 (2.44%)  1/29 (3.45%) 
Injury, poisoning and procedural complications                   
Ventriculoperitoneal shunt malfunction  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/82 (1.22%)  1/61 (1.64%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Nervous system disorders                   
Hydrocephalus  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/82 (2.44%)  1/61 (1.64%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Tethered cord syndrome  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  1/41 (2.44%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Asthma  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  1/61 (1.64%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tamsulosin - Low Dose Level (Steady State - PK Study) Tamsulosin - Medium Dose Level (Steady State - PK Study) Tamsulosin - High Dose Level (Steady State - PK Study) Tamsulosin - Low Dose Level (Group D-Denovo) Tamsulosin - Medium Dose Level (Group D-Denovo) Tamsulosin - High Dose Level (Group D-Denovo) Tamsulosin - Low Dose Level (Group D-527.51 Rollover) Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) Tamsulosin - High Dose Level (Group D-527.51 Rollover)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/10 (50.00%)   5/10 (50.00%)   3/10 (30.00%)   51/82 (62.20%)   25/61 (40.98%)   33/41 (80.49%)   31/93 (33.33%)   10/41 (24.39%)   9/29 (31.03%) 
Gastrointestinal disorders                   
Abdominal pain  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  4/82 (4.88%)  0/61 (0.00%)  1/41 (2.44%)  2/93 (2.15%)  0/41 (0.00%)  1/29 (3.45%) 
Abdominal pain upper  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  3/82 (3.66%)  1/61 (1.64%)  1/41 (2.44%)  2/93 (2.15%)  0/41 (0.00%)  0/29 (0.00%) 
Diarrhoea  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  4/82 (4.88%)  2/61 (3.28%)  2/41 (4.88%)  1/93 (1.08%)  2/41 (4.88%)  0/29 (0.00%) 
Vomiting  1  1/10 (10.00%)  1/10 (10.00%)  1/10 (10.00%)  9/82 (10.98%)  4/61 (6.56%)  3/41 (7.32%)  3/93 (3.23%)  2/41 (4.88%)  0/29 (0.00%) 
General disorders                   
Catheter related complication  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Mass  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  1/82 (1.22%)  0/61 (0.00%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Pyrexia  1  2/10 (20.00%)  0/10 (0.00%)  0/10 (0.00%)  12/82 (14.63%)  3/61 (4.92%)  6/41 (14.63%)  1/93 (1.08%)  1/41 (2.44%)  1/29 (3.45%) 
Suprapubic pain  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  0/61 (0.00%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Infections and infestations                   
Cervicitis  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/82 (1.22%)  0/61 (0.00%)  3/41 (7.32%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Influenza  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  3/82 (3.66%)  1/61 (1.64%)  1/41 (2.44%)  5/93 (5.38%)  0/41 (0.00%)  0/29 (0.00%) 
Nasopharyngitis  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  4/82 (4.88%)  3/61 (4.92%)  1/41 (2.44%)  5/93 (5.38%)  1/41 (2.44%)  2/29 (6.90%) 
Pharyngitis  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  11/82 (13.41%)  1/61 (1.64%)  2/41 (4.88%)  2/93 (2.15%)  1/41 (2.44%)  1/29 (3.45%) 
Upper respiratory tract infection  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/82 (1.22%)  1/61 (1.64%)  3/41 (7.32%)  1/93 (1.08%)  1/41 (2.44%)  0/29 (0.00%) 
Urinary tract infection  1  2/10 (20.00%)  1/10 (10.00%)  1/10 (10.00%)  15/82 (18.29%)  11/61 (18.03%)  16/41 (39.02%)  9/93 (9.68%)  3/41 (7.32%)  4/29 (13.79%) 
Investigations                   
Body temperature increased  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/82 (0.00%)  0/61 (0.00%)  1/41 (2.44%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Nervous system disorders                   
Dizziness  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  3/82 (3.66%)  1/61 (1.64%)  1/41 (2.44%)  1/93 (1.08%)  0/41 (0.00%)  0/29 (0.00%) 
Headache  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  8/82 (9.76%)  2/61 (3.28%)  3/41 (7.32%)  2/93 (2.15%)  1/41 (2.44%)  2/29 (6.90%) 
Psychiatric disorders                   
Nervousness  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/82 (0.00%)  1/61 (1.64%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Renal and urinary disorders                   
Hydronephrosis  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  2/82 (2.44%)  1/61 (1.64%)  3/41 (7.32%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  7/82 (8.54%)  1/61 (1.64%)  3/41 (7.32%)  1/93 (1.08%)  0/41 (0.00%)  0/29 (0.00%) 
Oropharyngeal pain  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  3/82 (3.66%)  0/61 (0.00%)  1/41 (2.44%)  1/93 (1.08%)  0/41 (0.00%)  0/29 (0.00%) 
Respiratory tract congestion  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/82 (1.22%)  0/61 (0.00%)  0/41 (0.00%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders                   
Rash  1  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  1/82 (1.22%)  2/61 (3.28%)  0/41 (0.00%)  0/93 (0.00%)  1/41 (2.44%)  0/29 (0.00%) 
Vascular disorders                   
Orthostatic hypotension  1  1/10 (10.00%)  1/10 (10.00%)  0/10 (0.00%)  1/82 (1.22%)  2/61 (3.28%)  1/41 (2.44%)  0/93 (0.00%)  0/41 (0.00%)  0/29 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 11.1
In Group D-527.51 Rollover study, due to the early termination caution should be used in interpreting these results due to the impact of the early termination, as well as the impact of the study design on interpretation of results by dose.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00340704    
Other Study ID Numbers: 527.66
First Submitted: June 19, 2006
First Posted: June 21, 2006
Results First Submitted: August 10, 2015
Results First Posted: February 17, 2016
Last Update Posted: February 17, 2016