Trial record 1 of 297 for:    A Phase III, Randomized, Open-Label, Parallel-Group, Dose-
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Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00756938
First received: September 18, 2008
Last updated: July 16, 2014
Last verified: July 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean Change From Baseline in Systolic Blood Pressure [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]
    Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.

  • Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s) [ Time Frame: up to 12 weeks (Base Study); up to 24 months (Extension) ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event [ Time Frame: up to 12 weeks (Base Study); up to 24 months (Extension) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Diastolic Blood Pressure [ Time Frame: Baseline and Day 21 ] [ Designated as safety issue: No ]
    Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.


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
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
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
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
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
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00756938     History of Changes
Other Study ID Numbers: 0954-337, 2008_545, CTRI/2009/091/000045
Study First Received: September 18, 2008
Results First Received: January 16, 2014
Last Updated: July 16, 2014
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 August 28, 2014