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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Losartan + Pbo Amlodipine
• Active Comparator: 2
  • Arm 2: Amlodipine + Pbo Losartan

Primary Measures

• Urine samples will be tested at Visit 3, 7, and 11 of the study for levels of protein and creatinine to see how well your kidneys are working after 12 weeks of treatment
  • Time Frame: 12 weeks of treatment
    Safety Issue?: No

Secondary Measures

• For patients that have high blood pressure, your blood pressure (BP) will be monitored to see how well the study drug is working after 12 weeks of treatment. BP will be checked at every study visit. You may also be advised by doctor to check BP at home.
  • Time Frame: 12 weeks of treatment
    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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on September 05, 2008

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results

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