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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092209
First Posted: September 24, 2004
Last Update Posted: March 18, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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, hydrochlorothiazide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 840
Study Start Date: April 2002
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Detailed Description:
The duration of treatment is 3.5 months.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00092209


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092209     History of Changes
Other Study ID Numbers: 0954A-302
2004_065
First Submitted: September 21, 2004
First Posted: September 24, 2004
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Antihypertensive Agents
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