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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amlodipine; Enalapril; Enalaprilat; Losartan

Criteria

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)