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

Phase 3TerminatedNCT00447603

Organon and Co40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

hydrochlorothiazide (+) losartan potassiumDRUG

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

losartan potassiumDRUG

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

Placebo for LosartanDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is male/female and 6 to 17 years of age at the time of study with hypertension (high blood pressure) * Patient is able to swallow tablets * Females of child bearing potential must use acceptable contraception throughout the trial Exclusion Criteria: * Patient has a history of heart, metabolic or kidney disease * Patient has a history of known heart, lung, liver and other body system disorders * Patient is pregnant or nursing * Patient has participated in another clinical trial within the last 28 days

Outcomes

Primary Outcomes

Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period

Time frame: Baseline and Week 4

Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study

Time frame: up to 4 weeks

Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study

Time frame: up to 4 weeks

Secondary Outcomes

Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period

Time frame: Baseline and Week 4

Data from ClinicalTrials.gov

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