Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337 AM4/AM5) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00756938

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: losartan potassium	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Potassium

Drug Information available for: Losartan Losartan potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from baseline in systolic blood pressure [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in diastolic blood pressure [ Time Frame: 21 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Losartan potassium 0.1 to 1.4 mg/kg	Drug: losartan potassium losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached. Other Name: Cozaar
Experimental: Losartan potassium 0.3 to 1.4 mg/kg	Drug: losartan potassium losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached. Other Name: Cozaar
Experimental: Losartan potassium 0.7 to 1.4 mg/kg	Drug: losartan potassium losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached. Other Name: Cozaar

Eligibility

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

Criteria

Inclusion Criteria:

Participant is determined to be hypertensive

Exclusion Criteria:

Participant has a history of severe or symptomatic hypertension
Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
Participant has started taking hypertensive medications within the past 30 days
Participant 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

Brazil
Merck Sharp & Dohme Farmaceutica Ltda.	Recruiting
Sao Paulo, SP, Brazil, 04717-004
Contact: Jose Octavio P. Costa Filo 55-11-5189-7942
Colombia
Frosst Laboratories Inc.	Recruiting
Bogota, Cundinamarca, Colombia
Contact: Felipe Arbelaez 57-1-592-4400
Hungary
MSD Magyarorszag Kft.	Recruiting
Budapest, Hungary, 1123
Contact: Tamas Soroncz-Szabo +36 1 457 8522
India
MSD Pharmaceuticals Private Ltd.	Recruiting
Gurgaon, India
Contact: Swashraya Shah 911244647338
Lithuania
UAB Merck Sharp & Dohme	Recruiting
Vilnius, Lietuva, Lithuania
Contact: Andrius Bacevicius 3705 2 780 243
Philippines
Merck Sharp & Dohme (I.A.) Corporation	Recruiting
Makati City, Philippines, 1229
Contact: Cesar Recto +632 784 9588
Romania
MSD Bucharest	Recruiting
Bucharest, Romania, Sector 1
Contact: Jean-Jacques Tiberi +4 021 233 3530
Russian Federation
Merck Sharp & Dohme IDEA, Inc.	Recruiting
Moscow, Russian Federation
Contact: Alexander Bedenkov 7(495) 916 7100
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Cesar Sanz Rodriguez 34913210886
United Kingdom
Merck Sharp & Dohme Ltd.	Recruiting
Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
Contact: Paul Robinson 44 1992 452396

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

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

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00756938 History of Changes
Other Study ID Numbers:	MK-0954-337, 2008_545
Study First Received:	September 18, 2008
Last Updated:	February 8, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012