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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00756938
First received: September 18, 2008
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  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 3

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:

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 ]

Enrollment: 101
Study Start Date: March 2009
Study Completion Date: August 2012
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

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: 0954-337, 2008_545
Study First Received: September 18, 2008
Last Updated: September 14, 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 May 21, 2013