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Trial record 35 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)

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ClinicalTrials.gov Identifier: NCT00447603
Recruitment Status : Terminated (Achieving site readiness and enrolling the trial within a reasonable time)
First Posted : March 15, 2007
Results First Posted : March 5, 2014
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: hydrochlorothiazide (+) losartan potassium
Drug: losartan potassium
Drug: Placebo for Losartan
Drug: Placebo for Losartan/HCTZ
Enrollment 40
Recruitment Details The study was discontinued early due to limited availability of sites and readiness of sites to enroll participants within the predefined time. Although some participants were screened and entered Filter Period, none were randomly assigned to a treatment arm and none entered double-blind treatment period.
Pre-assignment Details Enrolled participants entered screening. If initial criteria were met, eligible participants were separated into 2 strata based on weight and administered either 25-50mg or 50-100mg Losartan during Filter Period. Participant’s whose blood pressure did not respond were eligible to be randomly assigned to the Treatment period of the study.
Arm/Group Title All Enrolled Losartan 25 Mg-50 mg (Filter Period) Losartan 50 Mg-100 mg (Filter Period)
Hide Arm/Group Description Participants who met initial screening criteria for inclusion in study and were enrolled in the study. Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
Period Title: Screening
Started 40 0 0
Completed 19 0 0
Not Completed 21 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Protocol Violation             1             0             0
Screen Failure             4             0             0
Study Terminated by Sponsor             15             0             0
Period Title: Filter Period
Started 0 4 [1] 15 [1]
Completed 0 0 0
Not Completed 0 4 15
Reason Not Completed
Adverse Event             0             0             1
Screen Failure             0             3             4
Study terminated by Sponsor             0             1             10
[1]
The study was discontinued early; no participant entered treatment period
Arm/Group Title All Enrolled
Hide Arm/Group Description Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
All enrolled population which included all participants who provided consent and entered screening period of study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
13.7  (2.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
9
  22.5%
Male
31
  77.5%
1.Primary Outcome
Title Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.
Arm/Group Title Losartan 50 mg Losartan 100 mg Losartan 50 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study
Hide Description [Not Specified]
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.
Arm/Group Title Losartan 50 mg Losartan 100 mg Losartan 50 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study
Hide Description [Not Specified]
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.
Arm/Group Title Losartan 50 mg Losartan 100 mg Losartan 50 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period
Hide Description [Not Specified]
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.
Arm/Group Title Losartan 50 mg Losartan 100 mg Losartan 50 mg/HCTZ 12.5 mg Losartan 100 mg/HCTZ 12.5 mg
Hide Arm/Group Description:
Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 6 weeks (Filter period)
Adverse Event Reporting Description Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.
 
Arm/Group Title Losartan 25 Mg-50 mg (Filter Period) Losartan 50 Mg-100 mg (Filter Period)
Hide Arm/Group Description Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
All-Cause Mortality
Losartan 25 Mg-50 mg (Filter Period) Losartan 50 Mg-100 mg (Filter Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Losartan 25 Mg-50 mg (Filter Period) Losartan 50 Mg-100 mg (Filter Period)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Losartan 25 Mg-50 mg (Filter Period) Losartan 50 Mg-100 mg (Filter Period)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      2/15 (13.33%)    
Infections and infestations     
Pharyngitis  1  0/4 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications     
Mouth injury  1  1/4 (25.00%)  1 0/15 (0.00%)  0
Vascular disorders     
Hypotension  1  0/4 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.1
The study was discontinued early (during screening) due to limited availability of sites and readiness of sites to enroll participants within the predefined time.
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.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00447603     History of Changes
Other Study ID Numbers: 0954A-327
2007_502
First Submitted: March 14, 2007
First Posted: March 15, 2007
Results First Submitted: January 23, 2014
Results First Posted: March 5, 2014
Last Update Posted: August 21, 2018