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| Sponsor: | Merck |
|---|---|
| Information provided by (Responsible Party): | Merck |
| ClinicalTrials.gov Identifier: | NCT00568178 |
Purpose
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Proteinuria |
Drug: Losartan Potassium Other: Comparator: Placebo (Losartan) Drug: Comparator: amlodipine besylate Other: Comparator: Placebo (amlodipine besylate) Other: Placebo (Losartan) Drug: Enalapril Maleate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
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.
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.
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 the multiplier in place of 0.55]
Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase.
| Enrollment: | 306 |
| Study Start Date: | June 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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).
|
Drug: 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. Other Name: Cozaar®
Other: Comparator: Placebo (Losartan)
Placebo (losartan suspension), administered orally, once daily for 12 weeks
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|
Active Comparator: 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.
|
Other: Comparator: Placebo (Losartan)
Placebo (losartan suspension), administered orally, once daily for 12 weeks
Drug: 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
Other Name: NORVASC®
Other: Comparator: Placebo (amlodipine besylate)
Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks
Other Name: NORVASC®
Other: Placebo (Losartan)
Normotensive patients randomized to losartan placebo for 12 weeks.
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|
Experimental: 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).
|
Drug: 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. Other Name: Cozaar®
|
|
Active Comparator: 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).
|
Drug: Enalapril Maleate
Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 12 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00568178 History of Changes |
| Other Study ID Numbers: | MK-0954-326, 2006-006415-74 |
| Study First Received: | December 3, 2007 |
| Results First Received: | August 11, 2009 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Enalapril Enalaprilat Amlodipine Losartan Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
