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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00092209
• Lead Sponsor: Organon and Co

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.

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2002-11
• Study Completion: 2002-11
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean trough SiDBP after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Safety