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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Drug: Placebo for Losartan; Drug: losartan potassium; Drug: Placebo for Losartan/HCTZ; Drug: hydrochlorothiazide (+) losartan potassium

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Losartan 50 mg; Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks	Drug: losartan potassium; Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period; Other Names: MK0954; Drug: Placebo for Losartan/HCTZ; losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Active Comparator: Losartan 100 mg; Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks	Drug: losartan potassium; Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period; Other Names: MK0954; Drug: Placebo for Losartan/HCTZ; losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Experimental: Losartan 50 mg/HCTZ 12.5 mg; Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks	Drug: Placebo for Losartan; Drug: hydrochlorothiazide (+) losartan potassium; losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Other Names: MK0954A
Experimental: Losartan 100 mg/HCTZ 12.5 mg; Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks	Drug: Placebo for Losartan; Drug: hydrochlorothiazide (+) losartan potassium; losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Other Names: MK0954A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2007
• Primary Completion (Actual): October 22, 2007
• Study Completion (Actual): October 22, 2007

Study Registration Dates

• First Submitted: March 14, 2007
• First Submitted That Met QC Criteria: March 14, 2007
• First Posted (Estimate): March 15, 2007

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: 0954A-327; 2007_502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

1. CSR Synopsis
2. CSR Synopsis