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

Sponsor:	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 a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal Drug: Losartan 0.3 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal Drug: Losartan 0.7 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To define a dose-response relationship for losartan in hypertensive children ages 6 months to 6 years specifically the change from baseline in systolic blood pressure. [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate the safety and tolerability of losartan in hypertensive children ages 6 months to 6 years. Safety will be primarily measured by the number of patients with adverse experiences during the 12-week base study and extension. [ Time Frame: After 21 day treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2010
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 a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal 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 a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal 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 a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal 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

Show 26 Study Locations

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:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00756938 History of Changes
Health Authority:	United States: Food and Drug Administration

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 November 20, 2009