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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092209

Enrollment

840

Registered

2004-09-24

Start date

2002-04-30

Completion date

2002-11-30

Last updated

2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Detailed description

The duration of treatment is 3.5 months.

Interventions

DRUGMK0954A, hydrochlorothiazide (+) losartan potassium

DRUGComparator: placebo, losartan, hydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

25 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean trough SiDBP after 8 weeks of treatment	—

Secondary

Measure	Time frame
Safety	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026