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

This study has been completed.

First Received on September 21, 2004. Last Updated on January 21, 2010 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092209

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: MK0954A, hydrochlorothiazide (+) losartan potassium Drug: Comparator: placebo, losartan, hydrochorothiazide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure Potassium

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Mean trough SiDBP after 8 weeks of treatment

Secondary Outcome Measures:

Safety

Estimated Enrollment:	840
Study Start Date:	May 2002
Study Completion Date:	October 2002

Detailed Description:

The duration of treatment is 3.5 months.

Eligibility

Ages Eligible for Study:	25 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092209

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092209 History of Changes
Other Study ID Numbers:	2004_065
Study First Received:	September 21, 2004
Last Updated:	January 21, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012