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

Organon and Co101 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

101

Conditions

Hypertension

Interventions

losartan potassiumDRUG

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Day 21

Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)

Time frame: 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

Time frame: up to 12 weeks (Base Study); up to 24 months (Extension)

Secondary Outcomes

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.

Time frame: Baseline and Day 21

Data from ClinicalTrials.gov

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