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

February 3, 2022 updated by: Organon and Co

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of treatment is 3.5 months.

Study Type

Interventional

Enrollment

840

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean trough SiDBP after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

November 1, 2002

Study Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

September 21, 2004

First Submitted That Met QC Criteria

September 23, 2004

First Posted (Estimate)

September 24, 2004

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0954A-302
  • 2004_065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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