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

PHASE3CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

June 1, 2007

Primary Completion Date

September 1, 2008

Study Completion Date

March 1, 2011

Conditions
Proteinuria
Interventions
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.

All Listed Sponsors
lead

Organon and Co

INDUSTRY

NCT00568178 - An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2)) | Biotech Hunter | Biotech Hunter