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

• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: hydrochlorothiazide (+) losartan potassium; Drug: losartan potassium; Drug: Placebo for Losartan; Drug: Placebo for Losartan/HCTZ	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: May 24, 2007
• Actual Primary Completion Date: October 22, 2007
• Actual Study Completion Date: October 22, 2007

Arms and Interventions

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 Name: 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 Name: 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: hydrochlorothiazide (+) losartan potassium; losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Other Name: MK0954A; Drug: Placebo for Losartan
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: hydrochlorothiazide (+) losartan potassium; losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Other Name: MK0954A; Drug: Placebo for Losartan

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period [ Time Frame: Baseline and Week 4 ]
2. Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study [ Time Frame: up to 4 weeks ]
3. 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 Outcome Measures :

1. Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period [ Time Frame: Baseline and Week 4 ]

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Study Data/Documents: CSR Synopsis 

CSR Synopsis 

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00447603 History of Changes
• Other Study ID Numbers: 0954A-327; 2007_502
• First Posted: March 15, 2007
• Results First Posted: March 5, 2014
• Last Update Posted: August 21, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Hypertension; Losartan; Vascular Diseases; Cardiovascular Diseases; Hydrochlorothiazide; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Chloride Symporter Inhibitors; Membrane Transport Modulators