Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: losartan potassium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Change From Baseline in Systolic Blood PressureNumber of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s) Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
Secondary outcome: Mean Change From Baseline in Diastolic Blood Pressure
Eligibility
Minimum age: 6 Months.
Maximum age: 6 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Merck: Patient & Caregiver U.S. Product Web Site
Starting date: March 2009
Last updated: January 14, 2015
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