Clinical trial
A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension
Name
0954-326
Description
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
Trial arms
Trial start
2007-06-01
Estimated PCD
2008-09-01
Trial end
2011-03-01
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Losartan Double-Blind Base Study (12-weeks), Losartan Open-Label Extension Phase (Month 36)
Other names:
Cozaar®
Comparator: Placebo (Losartan)
Placebo (losartan suspension), administered orally, once daily for 12 weeks
Arms:
Amlodipine Double-Blind Base Study (12-weeks), Losartan Double-Blind Base Study (12-weeks)
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
Arms:
Amlodipine Double-Blind Base Study (12-weeks)
Other names:
NORVASC®
Comparator: Placebo (amlodipine besylate)
Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks
Arms:
Amlodipine Double-Blind Base Study (12-weeks)
Other names:
NORVASC®
Placebo (Losartan)
Normotensive patients randomized to losartan placebo for 12 weeks.
Arms:
Amlodipine Double-Blind Base Study (12-weeks)
Enalapril Maleate
Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.
Arms:
Enalapril Open-Label Extension Phase (Month 36)
Other names:
Vasotec®, Renitec®
Size
306
Primary endpoint
Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12
Baseline and Week 12
Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36
Baseline and Month 36
Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36
Baseline and Month 36
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 306, 'type': 'ACTUAL'}}
Updated at
2024-05-23
1 organization
Organization
Organon and Co