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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: MK0954A, hydrochlorothiazide (+) losartan potassium; Drug: Comparator: placebo, losartan, hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092209

2004_065

0954A-302

Details and patient eligibility

About

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.

Full description

The duration of treatment is 3.5 months.

Sex: All

Ages: 25 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind