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Completed

NCT Number: NCT00092209

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

25 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The duration of treatment is 3.5 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0954A, hydrochlorothiazide (+) losartan potassium

Drug

Comparator: placebo, losartan, hydrochlorothiazide

Drug

Primary outcomes

  1. Mean trough SiDBP after 8 weeks of treatment

Secondary outcomes

  1. Safety

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Sep 24, 2004
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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