Back to resultsAntihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0954A, hydrochlorothiazide (+) losartan potassium
Comparator: placebo, losartan, hydrochlorothiazide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Mean trough SiDBP after 8 weeks of treatment
Secondary Outcome Measures
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092209
Brief Title
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief 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.
Detailed Description
The duration of treatment is 3.5 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
840 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0954A, hydrochlorothiazide (+) losartan potassium
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo, losartan, hydrochlorothiazide
Primary Outcome Measure Information:
Title
Mean trough SiDBP after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17917321
Citation
Saruta T, Ogihara T, Matsuoka H, Suzuki H, Toki M, Hirayama Y, Nonaka K, Takahashi K. Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension. Hypertens Res. 2007 Aug;30(8):729-39. doi: 10.1291/hypres.30.729.
Results Reference
background
Learn more about this trial
Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
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