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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000690-34-EE
Enrollment
300
Registered
2007-04-13
Start date
2007-05-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension

Interventions

Trade Name: losartan potassium-hydrochlorothiazide 50-12.5: HYZAAR 100-12.5: COZAAR PLUS 100/12.5 Pharmaceutical Form: Tablet INN or Proposed INN: Losartan Potassium and Hydrochlorothiazide Current S
100-12.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: COZAAR Pharmaceutical Form: Tablet Current Sponsor code: MK-0954 Concentration unit:

Sponsors

Merck Sharp & Dohme OÜ
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Estonia, Finland, Germany, Hungary, Lithuania, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026