Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092209
First received: September 21, 2004
Last updated: July 7, 2014
Last verified: July 2014

September 21, 2004
July 7, 2014
May 2002
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Mean trough SiDBP after 8 weeks of treatment
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Complete list of historical versions of study NCT00092209 on ClinicalTrials.gov Archive Site
Safety
Not Provided
Not Provided
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Antihypertensive Efficacy and Safety of Approved Drugs in Japanese Patients With Essential Hypertension (Banyu Study)(0954A-302)
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

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.

The duration of treatment is 3.5 months.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK0954A, hydrochlorothiazide (+) losartan potassium
  • Drug: Comparator: placebo, losartan, hydrochlorothiazide
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
October 2002
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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
Both
25 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092209
0954A-302, 2004_065
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP