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

Organon and Co0 sites840 target enrollmentApril 2002

ConditionsHypertension

DrugsMK0954A, hydrochlorothiazide (+) losartan potassium Comparator: placebo, losartan, hydrochlorothiazide

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Organon and Co
Enrollment: 840
Primary Endpoint: Mean trough SiDBP after 8 weeks of treatment
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

November 2002

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

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