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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-01

Study Completion Date

2011-03-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Losartan Double-Blind Base Study (12-weeks)

Normotensive participants received losartan.

Hypertensive participants received either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo).

Group Type EXPERIMENTAL

Losartan Potassium

Intervention Type DRUG

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.

Comparator: Placebo (Losartan)

Intervention Type OTHER

Placebo (losartan suspension), administered orally, once daily for 12 weeks

Amlodipine Double-Blind Base Study (12-weeks)

Hypertensive participants were randomized to receive either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo) for 12 weeks.

Group Type ACTIVE_COMPARATOR

Comparator: Placebo (Losartan)

Intervention Type OTHER

Placebo (losartan suspension), administered orally, once daily for 12 weeks

Comparator: amlodipine besylate

Intervention Type DRUG

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

Comparator: Placebo (amlodipine besylate)

Intervention Type OTHER

Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks

Placebo (Losartan)

Intervention Type OTHER

Normotensive patients randomized to losartan placebo for 12 weeks.

Losartan Open-Label Extension Phase (Month 36)

Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).

Group Type EXPERIMENTAL

Losartan Potassium

Intervention Type DRUG

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.

Enalapril Open-Label Extension Phase (Month 36)

Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).

Group Type ACTIVE_COMPARATOR

Enalapril Maleate

Intervention Type DRUG

Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.

Interventions

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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.

Intervention Type DRUG

Comparator: Placebo (Losartan)

Placebo (losartan suspension), administered orally, once daily for 12 weeks

Intervention Type OTHER

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

Intervention Type DRUG

Comparator: Placebo (amlodipine besylate)

Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks

Intervention Type OTHER

Placebo (Losartan)

Normotensive patients randomized to losartan placebo for 12 weeks.

Intervention Type OTHER

Enalapril Maleate

Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.

Intervention Type DRUG

Other Intervention Names

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Cozaar® NORVASC® NORVASC® Vasotec® Renitec®

Eligibility Criteria

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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)

Minimum Eligible Age

12 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No