Clinical trial

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

Name

0954A-327

Description

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.

Trial arms

Trial start

2007-05-24

Estimated PCD

2007-10-22

Trial end

2007-10-22

Status

Terminated

Phase

Early phase I

Treatment

hydrochlorothiazide (+) losartan potassium

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

Arms:

Losartan 100 mg/HCTZ 12.5 mg, Losartan 50 mg/HCTZ 12.5 mg

Other names:

MK0954A

losartan potassium

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

Arms:

Losartan 100 mg, Losartan 50 mg

Other names:

MK0954

Placebo for Losartan

Arms:

Losartan 100 mg/HCTZ 12.5 mg, Losartan 50 mg/HCTZ 12.5 mg

Placebo for Losartan/HCTZ

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

Arms:

Losartan 100 mg, Losartan 50 mg

Size

Primary endpoint

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

Baseline and Week 4

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

up to 4 weeks

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

up to 4 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2024-05-23

1 organization

3 products

1 indication

Organization

Organon and Co

Product

Hydrochlorothiazide + Losartan potassium

Indication

Hypertension

Product

Losartan

Product

Placebo for Losartan + HCTZ