NCT00447603

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants who meet eligibility requirements will enter the single-blind Filter Period. Participants with either sitting systolic blood pressure (SiSBP) or sitting diastolic blood pressure (SiDBP) \>=95th percentile for gender/age/height will be administered either losartan 25 mg or losartan 50 mg depending on body weight (\<50 kg and \>=50 kg, respectively). After 3 weeks, if SiSBP or SiDBP is \>=95th percentile, participants will titrate to either losartan 50 mg or 100 mg according to weight. Participants with both SiSBP and SiDBP \<95th percentile will be excluded from the study. After an additional 3 weeks, participants whose blood pressure (either SiSBP or SiDBP) remains \>=95th percentile will then enter the double-blind phase. Participants who meet all entry criteria will be randomized in a 1:1 fashion to either losartan or losartan/hydrochlorothiazide (HCTZ) for 4 weeks and will be stratified according to body weight (\<50 kg and \>=50 kg). Participants whose weight is \<50 kg will be randomized to losartan 50 mg or losartan50 mg/HCTZ 12.5 mg. Participants weighing \>=50 kg will be randomized to losartan 100 mg or losartan/HCTZ 100 mg/12.5 mg. At the end of double-blind treatment, participants may enter a 20-week double-blind extension and will continue on their randomized therapy with losartan or losartan/HCTZ. 40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-05-24
• Primary completion: 2007-10-22
• Completion: 2007-10-22
• First posted: 2007-03-15
• Last updated: 2024-06-18
• Results posted: 2014-03-05