Study of Losartan in Pediatric Patients With Hypertension - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00756938

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: 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	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

To investigate the safety and tolerability of losartan in hypersensitive children ages 6 months to 6 years [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To define a dose-response relationship for losartan in hypersensitive children ages 6 months to 6 years [ Time Frame: After 21 day treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Losartan	Drug: Losartan 0.1 mg/kg/day titrating to 1.4 mg/kg/day Arm 1: starting dose is 0.1 mg/kg/day. Titrate dose at Week 3 to 0.3 mg/kg/day. At Week 6 titrate dose to 0.7 mg/kg/day. At week 9 titrate dose to 1.4 mg/kg/day. Treatment period is 12 weeks.
2: Experimental Losartan	Drug: Losartan 0.3 mg/kg/day titrating to 1.4 mg/kg/day Arm 2: starting dose of losartan is 0.3 mg/kg/day. At week 3 titrate dose to 0.7 mg/kg/day. At week 6 titrate dose to 1.4 mg/kg/day and will continue with dose until end of treatment. Treatment period is 12 weeks.
3: Experimental Losartan	Drug: Losartan 0.7 mg/kg/day titrating to 1.4 mg/kg/day Arm 3: Starting dose of Losartan is 0.7 mg/kg/day. At week 3 titrate dose to 1.4 mg/kg/day and continue on dose until end of treatment. Treatment period is 12 weeks.

Eligibility

Ages Eligible for Study:	6 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756938

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Florida
Call For Information	Recruiting
Miami, Florida, United States, 33155
United States, Indiana
Call For Information	Recruiting
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Call For Information	Recruiting
Lexington, Kentucky, United States, 40503
United States, New York
Call For Information	Recruiting
Williamsville, New York, United States, 14221
United States, Ohio
Call For Information	Recruiting
Akron, Ohio, United States, 44308
Lithuania, Lietuva
UAB Merck Sharp & Dohme	Recruiting
Vilnius, Lietuva, Lithuania
Contact: Andrius Bacevicius 3705 2 780 243

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_545, MK0954-337
Study First Received:	September 18, 2008
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00756938 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Losartan
Vascular Diseases
Cardiovascular Agents

Anti-Arrhythmia Agents
Angiotensin II
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Losartan
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009