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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: losartan potassium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756938

0954-337

CTRI/2009/091/000045 (Registry Identifier)

2008_545 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

Losartan potassium 0.1 to 1.4 mg/kg

Experimental group

Description:

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

Treatment:

Drug: losartan potassium

Losartan potassium 0.3 to 1.4 mg/kg

Experimental group

Description:

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

Treatment:

Drug: losartan potassium

Losartan potassium 0.7 to 1.4 mg/kg

Experimental group

Description:

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

Treatment:

Drug: losartan potassium