Study of Losartan in Pediatric Patients With Hypertension

Condition(s) targeted: Hypertension

Intervention: Losartan 0.1 mg/kg/day titrating to 1.4 mg/kg/day (Drug); Losartan 0.3 mg/kg/day titrating to 1.4 mg/kg/day (Drug); Losartan 0.7 mg/kg/day titrating to 1.4 mg/kg/day (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

This study will explore the dose-response of losartan as well as the safety and tolerability in children 6 months to 6 years.

Official title: A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension

Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To investigate the safety and tolerability of losartan in hypersensitive children ages 6 months to 6 years

Secondary outcome: To define a dose-response relationship for losartan in hypersensitive children ages 6 months to 6 years

Minimum age: 6 Months. Maximum age: 6 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is male or female 6 months to 6 years of age

- Patient is determined to be hypertensive

Exclusion Criteria:

- Patient has a history of severe or symptomatic hypertension

- Patient has history of heart failure, rhythm disturbance or cardiomyopathy, or

obstructive valvular disease

- Patient has started taking hypertensive medications within the past 30 days

- Patient has a known sensitivity to losartan or history of angioneurotic edema

Toll Free Number, Phone: 1-888-577-8839

Merck Sharp & Dohme (Argentina) Inc., Buenos Aires B1638BGN, Argentina; Recruiting
Alfredo Wilkinson, Phone: 54-11-4796-8347

Merck Sharp & Dohme (I.A.) Corp., Santiago 6761641, Chile; Recruiting
Margarita Charlin, MD, Phone: 562-655-8850

MSD Guatemala, Guatemala 1010, Guatemala; Recruiting
Patricia Salazar, Phone: 506-2210-0116

MSD Magyarorszag Kft., Budapest 1123, Hungary; Recruiting
Geza Szoverffy, Phone: 36-1 888 5325

MSD Pharmaceuticals Private Ltd., New Delhi 110011, India; Recruiting
Swashraya Shah, Phone: 91-124-464-7338

MSD (Norge) AS, Drammen 3011, Norway; Recruiting
Gunnar Saeter, Phone: 47 32 20 7460

Merck Sharp & Dohme (I.A.) Corporation, Makati City 1229, Philippines; Recruiting
Cesar "Butch" Recto II, Phone: 632-885-0700

MSD Bucharest, Bucharest Sector 1, Romania; Recruiting
Marius R. Ursa, Phone: 4021 316 8353

Merck Sharp & Dohme IDEA, Inc., Moscow 121059, Russian Federation; Recruiting
Tatiana Serebriakova, Phone: 7-495-941-8264

Merck Sharp & Dohme De Espana, S.A.E., Madrid 28027, Spain; Recruiting
Jorge Gonzalez-Esteban, Phone: 34-91-3210-728

Call For Information, Birmingham, Alabama 35233, United States; Recruiting

Call For Information, Little Rock, Arkansas 72202, United States; Recruiting

Call For Information, Orange, California 92868, United States; Recruiting

Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400

Call For Information, Miami, Florida 33155, United States; Recruiting

Merch Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452341

Call For Information, Indianapolis, Indiana 46260, United States; Recruiting

Call For Information, Lexington, Kentucky 40503, United States; Recruiting

UAB Merck Sharp & Dohme, Vilnius, Lietuva, Lithuania; Recruiting
Andrius Bacevicius, Phone: 3705 2 780 243

Call For Information, Williamsville, New York 14221, United States; Recruiting

Call For Information, Akron, Ohio 44308, United States; Recruiting

Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo, SP 04717-004, Brazil; Recruiting
Jose Octavio P. Costa Filo, Phone: 55-11-5189-7942

Call For Information, Salt Lake City, Utah 84132, United States; Recruiting

Call For Information, Marshfield, Wisconsin 54449, United States; Recruiting

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: December 2008
Ending date: January 2011
Last updated: October 16, 2009