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

NCT00447603 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-18

Study results available
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Summary

The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.

Conditions

Interventions

DRUG

hydrochlorothiazide (+) losartan potassium

losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.

DRUG

losartan potassium

Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period

DRUG

Placebo for Losartan

DRUG

Placebo for Losartan/HCTZ

losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-24
Primary Completion
2007-10-22
Completion
2007-10-22

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447603 on ClinicalTrials.gov