A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension - Pediatric Hypertension Efficacy Study
- Conditions
- Essential HypertensionMedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension
- Registration Number
- EUCTR2007-000690-34-HU
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Male or female and 6-17 years of age; essential hypertension(currently receiving antihypertensive therapy (= 2 medications) or trough SiSBP or SiDBP = 95th percentile and < 99th percentile + 5 mm Hg{Stage 1 HTN}); able to swallow tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Secondary hypertension (e.g. renal, CV, or endocrine cause of HTN); severe or symptomatic HTN within the past year; pregnancy or lactating; history of heart failure, hemodynamically significant obstructive valvular disease or cardiomyopathy; clinically significant neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease; organ transplantation; uncorrected coarctation of the aorta, bilateral renal artery stenosis, or renal artery stenosis to a single kidney
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the antihypertensive efficacy (as assessed by change in mean trough SiSBP) after 4 weeks of treatment with losartan/HCTZ combination therapy in comparison with losartan monotherapy in pediatric patients (defined as children aged 6-17 years who have the ability to swallow tablets) with essential hypertension (defined as patients = the 95th percentile for SBP or DBP for gender/age/height) who are not adequately controlled following a 6-week single-blind losartan treatment (filter) period.;Secondary Objective: To evaluate the antihypertensive efficacy (as assessed by change in mean trough SiDBP) of losartan/HCTZ combination therapy compared with losartan monotherapy in pediatric patients with essential hypertension following 4 weeks of treatment.;Primary end point(s): Change in mean trough SiSBP
- Secondary Outcome Measures
Name Time Method