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

NCT ID: NCT00447603

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-24
• Study Completion Date: 2007-10-22

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

losartan potassium

Intervention Type: DRUG

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

Placebo for Losartan/HCTZ

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

losartan potassium

Intervention Type: DRUG

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

Placebo for Losartan/HCTZ

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

hydrochlorothiazide (+) losartan potassium

Intervention Type: DRUG

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

Placebo for Losartan

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

hydrochlorothiazide (+) losartan potassium

Intervention Type: DRUG

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

Placebo for Losartan

Intervention Type: DRUG

Interventions

hydrochlorothiazide (+) losartan potassium

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

Intervention Type: DRUG

losartan potassium

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

Intervention Type: DRUG

Placebo for Losartan

Intervention Type: DRUG

Placebo for Losartan/HCTZ

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

Intervention Type: DRUG

Other Intervention Names

MK0954A; MK0954

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007_502

Identifier Type: -

Identifier Source: secondary_id

0954A-327

Identifier Type: -

Identifier Source: org_study_id