Clinical trial NCT00568178
Conditions: Proteinuria
Sponsor: Organon and Co
Start date: 2007-06-01; Completion date: 2011-03-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Normotensive participants received losartan.

Hypertensive participants received either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo). arm 2: Hypertensive participants were randomized to receive either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo) for 12 weeks. arm 3: Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient). arm 4: Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).
Interventions: intervention 1: Losartan Potassium intervention 2: Comparator: Placebo (Losartan) intervention 3: Comparator: amlodipine besylate intervention 4: Comparator: Placebo (amlodipine besylate) intervention 5: Placebo (Losartan) intervention 6: Enalapril Maleate
Intervention descriptions: intervention 1: 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. intervention 2: Placebo (losartan suspension), administered orally, once daily for 12 weeks intervention 3: 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 intervention 4: Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks intervention 5: Normotensive patients randomized to losartan placebo for 12 weeks. intervention 6: Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.

Protocol documents: