Study to Determine the Effects of Losartan on Proteinuria in Pediatric Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Proteinuria
Intervention: losartan potassium (Drug); Comparator: amlodipine besylate (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
The purpose of this study is to evaluate the effects of Losartan on proteinuria (protein
amounts in the urine) in pediatric patients.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: 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.
Eligibility
Minimum age: 1 Year.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme (I.A.) Corp., Santiago 6761641, Chile; Recruiting
Alfredo Wilkinson, Phone: 54-11-4796-8347
Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536
MSD Guatemala, Guatemala 1010, Guatemala; Recruiting
Patricia Salazar, Phone: 502 2 427-0922
MSD Pharmaceuticals Private Ltd., New Delhi 110011, India; Recruiting
Naveen Rao, Phone: 91 11 555 13086
MSD (Norge) AS, Drammen 3011, Norway; Recruiting
Ketil Berstad, Phone: 47-32-20-74-60
Merck Sharp & Dohme (I.A.) Corp., Panama Site Information, Panama; Recruiting
Patricia Salazar, Phone: 506-210-0116
Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700
Call for Information, San Juan 00936-5067, Puerto Rico; Recruiting
Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-095-941-8264
Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400
Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825
Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452341
Call for Information, Chicago, Illinois 60614-0000, United States; Recruiting
Call for Information, Louisville, Kentucky 40202, United States; Recruiting
Merck Sharp & Dohme, Peru S.R.L., Surquillo, Lima LIMA 34, Peru; Recruiting
Jorge Vinces, Phone: 511-411-5933
Call for Information, St. Louis, Missouri 63104, United States; Recruiting
Call for Information, Newark, New Jersey 07103, United States; Recruiting
Call for Information, Hackensack, New Jersey 07601, United States; Recruiting
Call for Information, New York, New York 10029, United States; Recruiting
Call for Information, New Hyde Park, New York 11040-0000, United States; Recruiting
Call for Information, Greenville, North Carolina 27834, United States; Recruiting
Call for Information, Tempe, Texas 76508, United States; Recruiting
Call for Information, Richmond, Virginia 23219, United States; Recruiting
Call for Information, Charlottesville, Virginia 229080000, United States; Recruiting
Additional Information
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
Starting date: May 2007
Last updated: June 11, 2008
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