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 Hypertension; MedDRA version: 9.1Level: LLTClassification code 10015488Term: Essential hypertension

• Registration Number: EUCTR2007-000690-34-EE
• Lead Sponsor: Merck Sharp & Dohme OÜ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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