Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: MK0954A, hydrochlorothiazide (+) losartan potassium (Drug); Comparator: placebo, losartan, hydrochorothiazide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
The purpose of this study is to evaluate antihypertensive (lowering blood pressure)
effectiveness of three combinations of approved study drugs compared to both study drugs
being given alone.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Study of the Anti-Hypertensive Efficacy and Safety of Losartan Monotherapy as Compared to HCTZ Monotherapy and to the Combination of Losartan and HCTZ in Japanese Patients With Essential Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Mean trough SiDBP after 8 weeks of treatment
Secondary outcome: Safety
Detailed description:
The duration of treatment is 3. 5 months.
Eligibility
Minimum age: 25 Years.
Maximum age: 74 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Japanese ancestry
- Stable high blood pressure defined by the study criteria
Exclusion Criteria:
- Pregnant or nursing
- Significant concurrent kidney, liver, blood, or other disease
- Recent heart attack or heart surgery
- History of stroke, severe hypertension (high blood pressure), significant heart
failure or cardiac arrhythmias
- Significant lab abnormalities
- Uncontrolled blood sugar
- History of certain drug allergies
Locations and Contacts
Additional Information
Starting date: May 2002
Ending date: October 2002
Last updated: January 2, 2008
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