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Trial record 49 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00092209
Recruitment Status : Completed
First Posted : September 24, 2004
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: MK0954A, hydrochlorothiazide (+) losartan potassium Drug: Comparator: placebo, losartan, hydrochlorothiazide Phase 3

Detailed Description:
The duration of treatment is 3.5 months.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2002
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mean trough SiDBP after 8 weeks of treatment

Secondary Outcome Measures :
  1. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00092209

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092209     History of Changes
Other Study ID Numbers: 0954A-302
First Posted: September 24, 2004    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators