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

A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: losartan potassium

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Losartan potassium 0.1 to 1.4 mg/kg; 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	Drug: losartan potassium; losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.; Other Names: Cozaar
Experimental: Losartan potassium 0.3 to 1.4 mg/kg; 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	Drug: losartan potassium; losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.; Other Names: Cozaar
Experimental: Losartan potassium 0.7 to 1.4 mg/kg; 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	Drug: losartan potassium; losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.; Other Names: Cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Systolic Blood Pressure	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.	Baseline and Day 21
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)
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

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Diastolic Blood Pressure	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.	Baseline and Day 21

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Webb NJ, Wells TG, Shahinfar S, Massaad R, Dankner WM, Lam C, Santoro EP, McCrary Sisk C, Blaustein RO. A randomized, open-label, dose-response study of losartan in hypertensive children. Clin J Am Soc Nephrol. 2014 Aug 7;9(8):1441-8. doi: 10.2215/CJN.11111113. Epub 2014 May 29.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2009
• Primary Completion (Actual): August 14, 2012
• Study Completion (Actual): August 14, 2012

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 19, 2008
• First Posted (Estimate): September 22, 2008

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; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: 0954-337; 2008_545 (Other Identifier: Merck Study Number); CTRI/2009/091/000045 (Registry Identifier: CTRI)

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