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

NCT ID: NCT00092209

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2002-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The duration of treatment is 3.5 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MK0954A, hydrochlorothiazide (+) losartan potassium

Intervention Type DRUG

Comparator: placebo, losartan, hydrochlorothiazide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Explore related publications, articles, or registry entries linked to this study.

Saruta T, Ogihara T, Matsuoka H, Suzuki H, Toki M, Hirayama Y, Nonaka K, Takahashi K. Antihypertensive efficacy and safety of fixed-dose combination therapy with losartan plus hydrochlorothiazide in Japanese patients with essential hypertension. Hypertens Res. 2007 Aug;30(8):729-39. doi: 10.1291/hypres.30.729.

Reference Type BACKGROUND
PMID: 17917321 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004_065

Identifier Type: -

Identifier Source: secondary_id

0954A-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Obese Hypertension Study (0954-315)
NCT00289887 COMPLETED PHASE3