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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: losartan potassium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan potassium 0.1 to 1.4 mg/kg<br>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<br>* 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.<br>* Other names: Cozaar;|
| Experimental: Losartan potassium 0.3 to 1.4 mg/kg<br>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<br>* 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.<br>* Other names: Cozaar;|
| Experimental: Losartan potassium 0.7 to 1.4 mg/kg<br>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<br>* 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.<br>* Other names: Cozaar;|

What is the study measuring?
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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 |