CompletedPhase 3

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

306 participantsStarted 2007-06-01

Plain-language summary

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

Who can participate

Age range12 Months – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12

Timeframe: Baseline and Week 12

Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36

Timeframe: Baseline and Month 36

Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36

Timeframe: Baseline and Month 36

Trial details

NCT IDNCT00568178

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09-01

Results submitted2009-08-11

View on ClinicalTrials.gov More Proteinuria trials