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

Organon

Status and phase: Completed; Phase 3

Conditions: Proteinuria

Treatments: Drug: Losartan Potassium; Drug: Enalapril Maleate; Other: Placebo (Losartan); Other: Comparator: Placebo (Losartan); Drug: Comparator: amlodipine besylate; Other: Comparator: Placebo (amlodipine besylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568178

2006-006415-74 (EudraCT Number)

0954-326

Details and patient eligibility

About

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

Full description

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.

Enrollment: 306 patients

Sex: All

Ages: 12 months to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 4 patient groups

Losartan Double-Blind Base Study (12-weeks)

Experimental group

Description:

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

Treatment:

Other: Comparator: Placebo (Losartan)

Drug: Losartan Potassium

Amlodipine Double-Blind Base Study (12-weeks)

Active Comparator group

Description:

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

Treatment:

Other: Comparator: Placebo (amlodipine besylate)

Drug: Comparator: amlodipine besylate

Other: Placebo (Losartan)

Other: Comparator: Placebo (Losartan)

Losartan Open-Label Extension Phase (Month 36)

Experimental group

Description:

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).

Treatment:

Drug: Losartan Potassium

Enalapril Open-Label Extension Phase (Month 36)

Active Comparator group

Description:

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).

Treatment:

Drug: Enalapril Maleate