Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: losartan potassium

• Registration Number: NCT00756938
• Lead Sponsor: Organon and Co

Brief Summary

This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Study Start: 2009-03-01
• Primary Completion: 2012-08-14
• Study Completion: 2012-08-14
• Disposition First Submitted: 2013-08-01
• Disposition First Submitted QC: 2013-08-01
• Disposition First Posted: 2013-08-08
• Results First Submitted: 2014-01-16
• Results First Submitted QC: 2014-01-16
• Results First Posted: 2014-03-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Participant is determined to be hypertensive

Exclusion Criteria

• Participant has a history of severe or symptomatic hypertension
• Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
• Participant has started taking hypertensive medications within the past 30 days
• Participant has a known sensitivity to losartan or history of angioneurotic edema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan potassium 0.1 to 1.4 mg/kg	losartan potassium	Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Losartan potassium 0.3 to 1.4 mg/kg	losartan potassium	Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Losartan potassium 0.7 to 1.4 mg/kg	losartan potassium	Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)	up to 12 weeks (Base Study); up to 24 months (Extension)
Mean Change From Baseline in Systolic Blood Pressure	Baseline and Day 21	Sitting blood pressure (\[BP\] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event	up to 12 weeks (Base Study); up to 24 months (Extension)

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Diastolic Blood Pressure	Baseline and Day 21	Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.