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

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

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.

Inclusion Criteria:

• Participant is 1 to 17 years of age
• Able to provide a first-morning urine sample each day during the study
• Documented history of proteinuria associated with chronic kidney disease of any origin
• Signed consent of parent and/or legal guardian

Exclusion Criteria:

• Pregnant and/or nursing
• Requires more than 2 medications to control high blood pressure
• Has undergone major organ transplantation (e.g. heart, kidney, liver)
• Known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema
• Known sensitivity to amlodipine or other calcium channel blocker
• Requires cyclosporine to treat renal disease (kidney disease)