Study to Determine the Effects of Losartan on Proteinuria in Pediatric Patients (0954-326)

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”

The purpose of this study is to evaluate the effects of Losartan on proteinuria (protein amounts in the urine) in pediatric patients.

This is a 12-week double-blind study with an optional open-label extension phase. Patients who completed or discontinued the 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 will continue until the 100th patient completes 3 years of follow-up.

Intervention(s) in this Clinical Trial

• Drug: Comparator: losartan potassium
  • losartan potassium 25 and 50 milligram (mg) tablets or suspension. Dose will titrate up to a maximum of 100mg (based on weight) orally per day (po qd).Duration of Treatment: 12 Weeks
• Drug: Comparator: Placebo to amlodipine
  • amlodipine besylate Placebo suspension 0.05 mg/kilogram (kg) (maximum 5mg/day).Duration of Treatment: 12 Weeks
• Drug: Comparator: amlodipine besylate
  • amlodipine besylate 0.05 mg/kg suspension (maximum 5mg/day.Duration of Treatment: 12 Weeks
• Drug: Comparator: Placebo to losartan
  • losartan potassium 25 and 50 mg placebo tablets or suspension po qd. Duration of Treatment: 12 Weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Normotensive patients: Losartan
• Placebo Comparator: 2
  • Arm 2: Normotensive patients: Placebo to Losartan
• Active Comparator: 3
  • Arm 3: Hypertensive patients: Amlodipine + Placebo to Losartan
• Experimental: 4
  • Arm 4: Hypertensive patients: Losartan + Placebo to Amlodipine

Primary Measures

• Percent Change From Baseline in Protein/Creatinine (Pr/Cr) Ratio at Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Systolic Blood Pressure in Hypertensive Patients at Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Change From Baseline in Diastolic Blood Pressure in Hypertensive Patients at Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No

Inclusion Criteria:

• Patient 1 to 17 years of age; Patient is able to provide a first morning urine sample
• Patient has documented history of proteinuria associated with chronic kidney disease of any origin
• A parent or legal guardian will need to sign a consent form
• The child may also be asked to sign a consent form, depending on his/her age

Exclusion Criteria:

• Patient is pregnant or nursing; Patients who needs more than 2 medications to control their high blood pressure
• Patient has nephrotic-range proteinuria that is steroid responsive
• Patient has undergone major organ transplantation (e.g. heart, kidney, liver)
• Patient has a known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema
• Patient has a known sensitivity to amlodipine or other calcium channel blocker
• Patient requires cyclosporine to treat renal disease
• Patient has any reason to think that they would not be cooperative, take study drug as asked, or not keep appointments

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Year

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568178

Study ID Number: 2006_560

ClinicalTrials.gov Identifier: NCT00568178

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site