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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension

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

Detailed Summary: 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.
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

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

    Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.

    Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period.

  • Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 [ Time Frame: Baseline and Month 36 ]

    Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.

    *The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase.

  • Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 [ Time Frame: Baseline and Month 36 ]

    The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:

    GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)

    GFR values were compared to the baseline GFR measure.

    [Note: For male participants, ages 13 to 17 years, 0.70 was used as

  • Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 [ Time Frame: Baseline and Week 12 ]


Original Secondary Outcome: For patients that have high blood pressure, your blood pressure (BP) will be monitored to see how well the study drug is working after 12 weeks of treatment. BP will be checked at every study visit. You may also be advised by doctor to check BP at home. [ Time Frame: 12 weeks of treatment ]

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: December 3, 2007
Date Started: June 2007
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2015