A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: hydrochlorothiazide (+) losartan potassium (Drug); losartan potassium (Drug); Comparator: losartan potassium (Drug); Comparator: Placebo (unspecified) (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to test the safety and effectiveness of Losartan as compared to
Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.
Clinical Details
Official title: A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Lower blood pressure
Secondary outcome: Well tolerated in pediatric patients.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is male/female and 6 to 17 years of age at the time of study with hypertension
(high blood pressure)
- Patient is able to swallow tablets
- Females of child bearing potential must use acceptable contraception throughout the
trial
Exclusion Criteria:
- Patient has a history of heart, metabolic or kidney disease
- Patient has a history of known heart, lung, liver and other body system disorders
- Patient is pregnant or nursing
- Patient has participated in another clinical trial within the last 28 days
Locations and Contacts
Additional Information
Starting date: April 2007
Ending date: October 2007
Last updated: December 23, 2007
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