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NCT00092209 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092209
Other study ID # 0954A-302
Secondary ID 2004_065
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2002
Est. completion date November 2002

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The duration of treatment is 3.5 months.

Recruitment information / eligibility
Status Completed
Enrollment 840
Est. completion date November 2002
Est. primary completion date November 2002
Accepts healthy volunteers No
Gender All
Age group 25 Years to 74 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MK0954A, hydrochlorothiazide (+) losartan potassium

• Comparator: placebo, losartan, hydrochlorothiazide

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Mean trough SiDBP after 8 weeks of treatment
Secondary Safety
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