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Trial record 12 of 134 for:    OLMESARTAN

Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure

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: NCT00151775
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : April 2, 2010
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: olmesartan medoxomil
Drug: placebo
Enrollment 362
Recruitment Details  
Pre-assignment Details Period 1 was a screening, wash-out period of approximately two weeks. All participants were included in the screening, wash-out period and during this period no intervention was administered.
Arm/Group Title Cohort A: High Dose OM in Periods 2, 3 Cohort A: Low Dose OM in Periods 2, 3 Cohort A: Placebo in Period 3 (From High Dose in Period 2) Cohort A: Placebo in Period 3 (From Low Dose in Period 2) Cohort A: Period 4 Open-label OM Cohort B: High Dose OM in Periods 2, 3 Cohort B: Low Dose OM in Periods 2, 3 Cohort B: Placebo in Period 3 (From High Dose in Period 2) Cohort B: Placebo in Period 3 (From Low Dose in Period 2) Cohort B: Period 4 Open-label OM Cohort C: OM in Periods 2, 3, 4 Cohort C: Placebo in Period 3 (From OM in Period 2)
Hide Arm/Group Description Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5). Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5). Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan. All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled. Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5). Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5). Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan. Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan. All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled. Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled. Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
Period Title: Period 2 - Double-Blind Dose Response
Started 95 95 0 0 0 56 56 0 0 0 60 0
Completed 93 89 0 0 0 54 53 0 0 0 59 0
Not Completed 2 6 0 0 0 2 3 0 0 0 1 0
Reason Not Completed
Adverse Event             1             2             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             1             0             0             0             0             0             1             0             0             0             1             0
Protocol Violation             0             4             0             0             0             0             0             0             0             0             0             0
Other             0             0             0             0             0             0             1             0             0             0             0             0
non-compliance             0             0             0             0             0             1             0             0             0             0             0             0
Physician Decision             0             0             0             0             0             1             0             0             0             0             0             0
The blood pressure goal was met             0             0             0             0             0             0             1             0             0             0             0             0
Period Title: Period 3: Double-blind, Withdrawal
Started 48 45 45 44 0 26 27 28 26 0 29 29
Completed 48 45 42 44 0 25 26 27 26 0 29 28
Not Completed 0 0 3 0 0 1 1 1 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1             0             0             0             0             0             0
Other             0             0             1             0             0             0             0             1             0             0             0             0
Met blood pressure goal             0             0             0             0             0             0             1             0             0             0             0             0
Adverse Event             0             0             1             0             0             0             0             0             0             0             0             0
Protocol Violation             0             0             1             0             0             0             0             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             1
Period Title: Period 4: Open Label
Started 0 0 0 0 179 0 0 0 0 104 57 0
Completed 0 0 0 0 149 0 0 0 0 83 57 0
Not Completed 0 0 0 0 30 0 0 0 0 21 0 0
Reason Not Completed
Increased blood pressure             0             0             0             0             1             0             0             0             0             1             0             0
Withdrawal by Subject             0             0             0             0             5             0             0             0             0             2             0             0
Adverse Event             0             0             0             0             1             0             0             0             0             2             0             0
Lost to Follow-up             0             0             0             0             17             0             0             0             0             7             0             0
Non-compliance with protocol             0             0             0             0             4             0             0             0             0             4             0             0
Other             0             0             0             0             1             0             0             0             0             3             0             0
Physician Decision             0             0             0             0             0             0             0             0             0             2             0             0
Protocol Violation             0             0             0             0             1             0             0             0             0             0             0             0
Arm/Group Title Cohort A: High Dose OM Cohort A: Low Dose OM Cohort B: High Dose OM Cohort B: Low Dose OM Cohort C: OM (Olmesartan Medoxomil) Total
Hide Arm/Group Description Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period). Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period). Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period). Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period). Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled. Total of all reporting groups
Overall Number of Baseline Participants 95 95 56 56 60 362
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
12.1  (2.97) 12.3  (2.98) 12.2  (2.83) 12.8  (2.42) 3.4  (1.45) 12.3  (2.85)
[1]
Measure Description: The data provided for the total study population includes only Cohorts A+B.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
Female
33
  34.7%
35
  36.8%
35
  62.5%
20
  35.7%
26
  43.3%
149
  41.2%
Male
62
  65.3%
60
  63.2%
21
  37.5%
36
  64.3%
34
  56.7%
213
  58.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
Latino/Hispanic 42 47 0 1 27 117
non-Latino/Hispanic 53 48 56 55 33 245
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
153.3  (18.46) 155.1  (19.12) 154.2  (17.83) 156.1  (14.21) 98.3  (12.92) 154.6  (17.79)
[1]
Measure Description: The data provided for the total study population is only for Cohorts A+B
Seated Systolic blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
129.1  (8.32) 129.5  (9.10) 130.8  (9.73) 131.7  (9.12) 115.2  (8.74) 130.0  (9.00)
[1]
Measure Description: The data provided for the total study population is only for Cohort A+B
Seated diastolic blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
76.3  (8.09) 78.1  (8.17) 79.2  (7.08) 79.4  (9.05) 72.7  (8.74) 78.0  (8.18)
[1]
Measure Description: The data provided for the total study population consists only of Cohort A+B
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 95 participants 95 participants 56 participants 56 participants 60 participants 362 participants
68.0  (34.22) 78.9  (41.85) 66.2  (32.39) 68.1  (34.36) 16.9  (6.61) 71.1  (36.72)
[1]
Measure Description: The data provided for the total study population is only for Cohort A+B
1.Primary Outcome
Title Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
Hide Description The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.
Time Frame Day 0 to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.
Arm/Group Title Cohort A Cohort B Cohorts A + B
Hide Arm/Group Description:
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
Overall Number of Participants Analyzed 190 112 302
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Non-weight adjusted dosage -0.69  (0.202) -0.85  (0.282) -0.75  (0.165)
Weight adjusted dosage -8.97  (2.054) -7.17  (3.190) -8.36  (1.750)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments Non-weight adjusted dosage
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments Weight adjusted dosage
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort B
Comments Non-weight adjusted dosage
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort B
Comments Weight adjusted dosage
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0265
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohorts A + B
Comments Non-weight adjusted dosage
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohorts A + B
Comments Weight adjusted dosage
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Primary Outcome
Title Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
Hide Description Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Time Frame Day 0 (baseline) to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used
Arm/Group Title Cohort A: Low Dose OM Cohort A: High Dose OM Cohort B: Low Dose OM Cohort B: High Dose OM Cohorts A + B: Low Dose OM Cohorts A + B: High Dose OM
Hide Arm/Group Description:
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
Overall Number of Participants Analyzed 94 94 56 56 150 150
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change in Systolic Blood Pressure -7.76  (9.180) -12.58  (10.157) -4.73  (11.483) -10.68  (9.259) -6.63  (10.170) -11.87  (9.843)
Change in Diastolic Blood Pressure -5.52  (8.058) -9.50  (9.757) -3.49  (8.844) -7.58  (8.172) -4.76  (8.389) -8.78  (9.216)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Low Dose OM, Cohort A: High Dose OM
Comments A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Low Dose OM, Cohort A: High Dose OM
Comments A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.057
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort B: Low Dose OM, Cohort B: High Dose OM
Comments A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort B: Low Dose OM, Cohort B: High Dose OM
Comments A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0125
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.58
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohorts A + B: Low Dose OM, Cohorts A + B: High Dose OM
Comments A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohorts A + B: Low Dose OM, Cohorts A + B: High Dose OM
Comments A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort A: Low Dose OM, Cohort A: High Dose OM
Comments A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -8.97
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort A: Low Dose OM, Cohort A: High Dose OM
Comments A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -8.15
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort B: Low Dose OM, Cohort B: High Dose OM
Comments A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0265
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -7.17
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort B: Low Dose OM, Cohort B: High Dose OM
Comments A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -6.85
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Cohorts A + B: Low Dose OM, Cohorts A + B: High Dose OM
Comments A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -8.36
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Cohorts A + B: Low Dose OM, Cohorts A + B: High Dose OM
Comments A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -7.71
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Hide Description Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Time Frame Week 3 (period 3 baseline) to week 5 (end of Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.
Arm/Group Title Cohort A: OM Period 3 Cohort A: Placebo Period 3 Cohort B: OM Period 3 Cohort B: Placebo Period 3 Cohorts A + B: OM Period 3 Cohorts A + B: Placebo Period 3
Hide Arm/Group Description:
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
Overall Number of Participants Analyzed 93 89 53 54 146 143
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change in Systolic Blood Pressure 0.43  (9.46) 4.93  (9.62) 1.37  (9.50) 3.79  (10.00) 0.77  (9.451) 4.50  (9.745)
Change in Diastolic Blood Pressure 0.24  (8.12) 4.43  (10.15) 1.94  (7.10) 3.25  (8.74) 0.85  (7.790) 3.99  (9.627)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: OM Period 3, Cohort A: Placebo Period 3
Comments Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0093
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.58
Confidence Interval (2-Sided) 95%
-6.27 to -0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: OM Period 3, Cohort A: Placebo Period 3
Comments Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -3.49
Confidence Interval (2-Sided) 95%
-5.92 to -1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort B: OM Period 3, Cohort B: Placebo Period 3
Comments Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1330
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.57
Confidence Interval (2-Sided) 95%
-5.93 to 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort B: OM Period 3, Cohort B: Placebo Period 3
Comments Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3442
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-4.27 to 1.50
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohorts A + B: OM Period 3, Cohorts A + B: Placebo Period 3
Comments For seated systolic blood pressure the null hypothesis of no treatment difference was tested
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0029
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -3.16
Confidence Interval (2-Sided) 95%
-5.24 to -1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohorts A + B: OM Period 3, Cohorts A + B: Placebo Period 3
Comments For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.80
Confidence Interval (2-Sided) 95%
-4.65 to -0.95
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Hide Description Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.
Time Frame Week 3 (period 3 baseline) to week 5 (end of Period 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.
Arm/Group Title Cohort C: OM Period 3 Cohort C: Placebo Period 3
Hide Arm/Group Description:
Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: mm Hg
Seated Systolic Blood Pressure 1.36  (8.994) 4.95  (8.568)
Seated Diastolic Blood Pressure 0.31  (8.556) 3.77  (7.203)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort C: OM Period 3, Cohort C: Placebo Period 3
Comments For seated systolic blood pressure the null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2113
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.82
Confidence Interval (2-Sided) 95%
-7.29 to 1.65
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort C: OM Period 3, Cohort C: Placebo Period 3
Comments For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1496
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA model used treatment and country as fixed effects and baseline as covariate.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.92
Confidence Interval (2-Sided) 95%
-6.92 to 1.09
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Hide Description Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Time Frame Day 0 to week 51 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population includes participants with at least one visit in Period 4.
Arm/Group Title Cohort A: Period 4 Open-label OM Cohort B: Period 4 Open-label OM Cohorts A + B: Period 4 Open-label OM
Hide Arm/Group Description:
All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
All members of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
Overall Number of Participants Analyzed 178 103 281
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change in Systolic Blood Pressure -10.8  (9.75) -7.7  (12.71) -9.7  (11.01)
Change in Diastolic Blood Pressure -7.4  (9.31) -5.1  (9.45) -6.6  (9.41)
6.Secondary Outcome
Title Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Hide Description Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.
Time Frame Day 0 to week 51 week (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
57=the number of participants who received medication in Period 4
Arm/Group Title Cohort C: OM (Olmesartan Medoxomil)
Hide Arm/Group Description:
Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change in Systolic Blood Pressure -15.7  (9.83)
Change in Diastolic Blood Pressure -13.3  (11.18)
Time Frame Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
Adverse Event Reporting Description AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator’s opinion of the causal relationship to the treatment.
 
Arm/Group Title Cohort A: Period 2 High Dose OM Cohort A: Period 2 Low Dose OM Cohort A: Period 3 OM High Dose Continued Cohort A: Period 3 Placebo From High Dose Cohort A: Period 3 OM Low Dose Continued Cohort A: Period 3 Placebo From Low Dose Cohort A: Period 4 Open-label OM Cohort B: Period 2 High Dose OM Cohort B: Period 2 Low Dose OM Cohort B: Period 3 OM High Dose Continued Cohort B: Period 3 Placebo From High Dose Cohort B: Period 3 OM Low Dose Continued Cohort B: Period 3 Placebo From Low Dose Cohort B: Period 4 Open-label OM Cohort C: Period 2 Open-label OM Cohort C: Period 3 OM Dose Continued Cohort C: Period 3 Placebo Cohort C: Period 4 Open-label OM
Hide Arm/Group Description For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight. For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight. The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued. Placebo was given instead of the previous high dose of olmesartan The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued. Placebo was given instead of the previous low dose of olmesartan 10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled. For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight. For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight. The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued. Placebo was given instead of the previous high dose of olmesartan The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued. Placebo was given instead of the previous low dose of olmesartan 10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled. The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age. The 0.3 mg/kg dose of OM was continued for these participants The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo. Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
All-Cause Mortality
Cohort A: Period 2 High Dose OM Cohort A: Period 2 Low Dose OM Cohort A: Period 3 OM High Dose Continued Cohort A: Period 3 Placebo From High Dose Cohort A: Period 3 OM Low Dose Continued Cohort A: Period 3 Placebo From Low Dose Cohort A: Period 4 Open-label OM Cohort B: Period 2 High Dose OM Cohort B: Period 2 Low Dose OM Cohort B: Period 3 OM High Dose Continued Cohort B: Period 3 Placebo From High Dose Cohort B: Period 3 OM Low Dose Continued Cohort B: Period 3 Placebo From Low Dose Cohort B: Period 4 Open-label OM Cohort C: Period 2 Open-label OM Cohort C: Period 3 OM Dose Continued Cohort C: Period 3 Placebo Cohort C: Period 4 Open-label OM
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 (%) 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   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A: Period 2 High Dose OM Cohort A: Period 2 Low Dose OM Cohort A: Period 3 OM High Dose Continued Cohort A: Period 3 Placebo From High Dose Cohort A: Period 3 OM Low Dose Continued Cohort A: Period 3 Placebo From Low Dose Cohort A: Period 4 Open-label OM Cohort B: Period 2 High Dose OM Cohort B: Period 2 Low Dose OM Cohort B: Period 3 OM High Dose Continued Cohort B: Period 3 Placebo From High Dose Cohort B: Period 3 OM Low Dose Continued Cohort B: Period 3 Placebo From Low Dose Cohort B: Period 4 Open-label OM Cohort C: Period 2 Open-label OM Cohort C: Period 3 OM Dose Continued Cohort C: Period 3 Placebo Cohort C: Period 4 Open-label OM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/95 (2.11%)      1/95 (1.05%)      0/48 (0.00%)      0/45 (0.00%)      0/45 (0.00%)      0/44 (0.00%)      20/179 (11.17%)      0/56 (0.00%)      0/56 (0.00%)      1/26 (3.85%)      0/28 (0.00%)      0/27 (0.00%)      0/26 (0.00%)      7/104 (6.73%)      0/59 (0.00%)      0/29 (0.00%)      0/29 (0.00%)      6/57 (10.53%)    
Congenital, familial and genetic disorders                                     
Coarctation of the aorta  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Eye disorders                                     
Eye hemorrhage  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 1/57 (1.75%) 
Ophthalmoplegia  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/104 (1.92%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 1/57 (1.75%) 
Gastrointestinal disorders                                     
Peritonitis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/104 (0.96%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Vomiting  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 2/179 (1.12%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/0  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%) 
General disorders                                     
Anasarca  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Infections and infestations                                     
Abcess limb  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/104 (0.96%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Bronchitis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Broncopneumonia  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 3/179 (1.68%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 2/57 (3.51%) 
Pneumonia  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 1/57 (1.75%) 
Pyelonephritis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/26 (3.85%)  0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Sinusitis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 2/179 (1.12%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Upper respiratory infection  1  1/95 (1.05%)  0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Investigations                                     
Laparoscopy  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Metabolism and nutrition disorders                                     
Diabetic ketoacidosis  1  0/95 (0.00%)  0 1/95 (1.05%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Hypoproteinemia  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Metabolic disorder  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Musculoskeletal and connective tissue disorders                                     
Arthralgia  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 2/179 (1.12%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Systemic lupus erythematosus  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/104 (0.96%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Psychiatric disorders                                     
Depression  1  1/95 (1.05%)  0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Mental disorder  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Suicide attempt  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Renal and urinary disorders                                     
Nephrotic syndrome  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Ureteric stenosis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 1/179 (0.56%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/0  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%) 
Reproductive system and breast disorders                                     
Ovarian cyst  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/104 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders                                     
Asthma  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/104 (0.96%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Epistaxis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/179 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 1/104 (0.96%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/29 (0.00%)  0 0/57 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Cohort A: Period 2 High Dose OM Cohort A: Period 2 Low Dose OM Cohort A: Period 3 OM High Dose Continued Cohort A: Period 3 Placebo From High Dose Cohort A: Period 3 OM Low Dose Continued Cohort A: Period 3 Placebo From Low Dose Cohort A: Period 4 Open-label OM Cohort B: Period 2 High Dose OM Cohort B: Period 2 Low Dose OM Cohort B: Period 3 OM High Dose Continued Cohort B: Period 3 Placebo From High Dose Cohort B: Period 3 OM Low Dose Continued Cohort B: Period 3 Placebo From Low Dose Cohort B: Period 4 Open-label OM Cohort C: Period 2 Open-label OM Cohort C: Period 3 OM Dose Continued Cohort C: Period 3 Placebo Cohort C: Period 4 Open-label OM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/95 (49.47%)      46/95 (48.42%)      15/48 (31.25%)      6/45 (13.33%)      9/45 (20.00%)      6/44 (13.64%)      128/178 (71.91%)      9/56 (16.07%)      12/56 (21.43%)      4/26 (15.38%)      1/28 (3.57%)      2/27 (7.41%)      1/26 (3.85%)      56/103 (54.37%)      12/59 (20.34%)      4/29 (13.79%)      8/28 (28.57%)      46/57 (80.70%)    
Gastrointestinal disorders                                     
Abdominal pain upper  1  3/95 (3.16%)  5/95 (5.26%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 10/178 (5.62%)  1/56 (1.79%)  0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 9/103 (8.74%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/57 (0.00%)  0
Vomiting  1  1/95 (1.05%)  3/95 (3.16%)  3/48 (6.25%)  0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 11/178 (6.18%)  0/56 (0.00%)  0 1/56 (1.79%)  0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 7/103 (6.80%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 3/57 (5.26%) 
Diarrhea  1  1/95 (1.05%)  2/95 (2.11%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 2/178 (1.12%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 3/103 (2.91%)  1/59 (1.69%)  0/29 (0.00%)  0 1/28 (3.57%)  4/57 (7.02%) 
General disorders                                     
Pyrexia  1  4/95 (4.21%)  4/95 (4.21%)  3/48 (6.25%)  0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 16/178 (8.99%)  1/56 (1.79%)  0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/103 (1.94%)  3/59 (5.08%)  0/29 (0.00%)  0 0/28 (0.00%)  0 7/57 (12.28%) 
Infections and infestations                                     
Nasopharyngitis  1  1/95 (1.05%)  4/95 (4.21%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 16/178 (8.99%)  1/56 (1.79%)  2/56 (3.57%)  0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 4/103 (3.88%)  1/59 (1.69%)  0/29 (0.00%)  0 2/28 (7.14%)  2/57 (3.51%) 
Upper respiratory tract infection  1  7/95 (7.37%)  4/95 (4.21%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 20/178 (11.24%)  0/56 (0.00%)  0 2/56 (3.57%)  0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 3/103 (2.91%)  1/59 (1.69%)  1/29 (3.45%)  0/28 (0.00%)  0 11/57 (19.30%) 
Influenza  1  1/95 (1.05%)  0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 2/44 (4.55%)  10/178 (5.62%)  0/56 (0.00%)  0 2/56 (3.57%)  1/26 (3.85%)  0/28 (0.00%)  0 1/27 (3.70%)  0/26 (0.00%)  0 4/103 (3.88%)  1/59 (1.69%)  1/29 (3.45%)  1/28 (3.57%)  3/57 (5.26%) 
Pharyngitis  1  4/95 (4.21%)  2/95 (2.11%)  0/48 (0.00%)  0 3/45 (6.67%)  2/45 (4.44%)  0/44 (0.00%)  0 7/178 (3.93%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 2/57 (3.51%) 
Otitis media acute  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 1/59 (1.69%)  0/29 (0.00%)  0 0/28 (0.00%)  0 3/57 (5.26%) 
Tonsilitis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 5/57 (8.77%) 
Urinary tract infection  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 4/178 (2.25%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 4/57 (7.02%) 
Viral infection  1  0/95 (0.00%)  0 2/95 (2.11%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 3/57 (5.26%) 
Investigations                                     
Blood urea increased  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 2/45 (4.44%)  0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0/57 (0.00%)  0
Metabolism and nutrition disorders                                     
Pseudohyperkalemia  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 2/28 (7.14%)  0/57 (0.00%)  0
Nervous system disorders                                     
Dizziness  1  9/95 (9.47%)  2/95 (2.11%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 10/178 (5.62%)  1/56 (1.79%)  0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/103 (1.94%)  0/59 (0.00%)  0 0/29 (0.00%)  0 1/28 (3.57%)  0/57 (0.00%)  0
Headache  1  14/95 (14.74%)  7/95 (7.37%)  4/48 (8.33%)  1/45 (2.22%)  3/45 (6.67%)  2/44 (4.55%)  30/178 (16.85%)  5/56 (8.93%)  3/56 (5.36%)  2/26 (7.69%)  0/28 (0.00%)  0 1/27 (3.70%)  1/26 (3.85%)  18/103 (17.48%)  1/59 (1.69%)  0/29 (0.00%)  0 0/28 (0.00%)  0 1/57 (1.75%) 
Renal and urinary disorders                                     
Nephrotic syndrome  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 5/57 (8.77%) 
Proteinurea  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 3/57 (5.26%) 
Respiratory, thoracic and mediastinal disorders                                     
Pharyngolaryngeal pain  1  1/95 (1.05%)  6/95 (6.32%)  2/48 (4.17%)  0/45 (0.00%)  0 1/45 (2.22%)  1/44 (2.27%)  12/178 (6.74%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 1/28 (3.57%)  0/27 (0.00%)  0 0/26 (0.00%)  0 3/103 (2.91%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/57 (0.00%)  0
Cough  1  0/95 (0.00%)  0 0/95 (0.00%)  0 3/48 (6.25%)  0/45 (0.00%)  0 1/45 (2.22%)  1/44 (2.27%)  24/178 (13.48%)  0/56 (0.00%)  0 0/56 (0.00%)  0 1/26 (3.85%)  0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 7/103 (6.80%)  3/59 (5.08%)  1/29 (3.45%)  1/28 (3.57%)  5/57 (8.77%) 
Rhinorrhea  1  2/95 (2.11%)  3/95 (3.16%)  0/48 (0.00%)  0 0/45 (0.00%)  0 2/45 (4.44%)  0/44 (0.00%)  0 4/178 (2.25%)  0/56 (0.00%)  0 1/56 (1.79%)  0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/103 (1.94%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/57 (0.00%)  0
Epistaxis  1  0/95 (0.00%)  0 2/95 (2.11%)  0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 3/178 (1.69%)  0/56 (0.00%)  0 1/56 (1.79%)  0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 5/103 (4.85%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 2/57 (3.51%) 
Nasal congestion  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 9/178 (5.06%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/103 (1.94%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 0/57 (0.00%)  0
Asthma  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 6/178 (3.37%)  0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 2/103 (1.94%)  0/59 (0.00%)  0 0/29 (0.00%)  0 0/28 (0.00%)  0 6/57 (10.53%) 
Rhinitis  1  0/95 (0.00%)  0 0/95 (0.00%)  0 0/48 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/44 (0.00%)  0 0/178 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 0/26 (0.00%)  0 0/28 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0 0/103 (0.00%)  0 0/59 (0.00%)  0 1/29 (3.45%)  0/28 (0.00%)  0 4/57 (7.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
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.
If identified by Daiichi Sankyo Inc.(DSI), any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving DSI any right of editorial control over any publication prepared by the study site.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Howard Kessler, Senior Director Regulatory Operations
Organization: Daiichi Sankyo
Phone: 732-590-5032
EMail: hmkessler@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00151775     History of Changes
Other Study ID Numbers: CS0866-A-U301
First Submitted: September 7, 2005
First Posted: September 9, 2005
Results First Submitted: March 8, 2010
Results First Posted: April 2, 2010
Last Update Posted: June 30, 2016