NCT00568178

An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))

A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.

Detailed description

The study included a 12-week double-blind treatment phase and a 36-month open-label extension phase. Participants who completed or discontinued the initial 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. The open label extension was designed to continue until the 100th participant completed 3 years of follow-up.

Conditions

• Proteinuria

Interventions

Type	Name	Description
DRUG	Losartan Potassium	Losartan Use During the Double-Blind Treatment Phase: Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed \<50 kg) or 100 mg/day (if the patient weighed ≥50 kg). Losartan Use During the Treatment Extension Phase: Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance.
OTHER	Comparator: Placebo (Losartan)	Placebo (losartan suspension), administered orally, once daily for 12 weeks
DRUG	Comparator: amlodipine besylate	Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks
OTHER	Comparator: Placebo (amlodipine besylate)	Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks
OTHER	Placebo (Losartan)	Normotensive patients randomized to losartan placebo for 12 weeks.
DRUG	Enalapril Maleate	Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-09-01
• Completion: 2011-03-01
• First posted: 2007-12-05
• Last updated: 2024-05-23
• Results posted: 2009-10-30