Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients

NCT00135551 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3501

Last updated 2012-02-22

No results posted yet for this study

Summary

A number of major clinical trials have demonstrated the clinical benefits of lowering blood pressure and have indicated that a majority of patients with hypertension will require more than one drug to achieve optimal blood pressure control.

There is little data showing which antihypertensive combination best protects patients from cardiovascular events and which best achieves the target blood pressure with the fewest adverse events.

The COPE trial is planned to investigate, in patients with hypertension, which combination of the antihypertensive drugs, angiotensin receptor blockers, β-blockers or thiazide diuretics in addition to a long-acting calcium antagonist, benidipine hydrochloride, is superior to achieve the targeted blood pressure and prevent cardiovascular events with the fewest adverse drug effects.

Conditions

Interventions

DRUG

Angiotensin receptor blockers

benidipine+angiotensin receptor blocker, titlation scheme

DRUG

β-blockers

benidipine+β-blockers, titlation scheme

DRUG

thiazide diuretics

benidipie+thiazide diuretics, titlation scheme

Sponsors & Collaborators

  • The Japanese Society of Hypertension

    collaborator OTHER
  • Yamaguchi University Hospital

    collaborator OTHER
  • Kyowa Hakko Kogyo Co., Ltd.

    collaborator INDUSTRY
  • Seiji Umemoto, M.D., Ph.D.

    lead OTHER

Principal Investigators

  • Toshio Ogihara, MD, PhD · Department of Geriatric Medicine, Osaka University Graduate School of Medicine

  • Takao Saruta, MD, PhD · Department of Internal Medicine, Keio University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2010-05-31
Completion
2010-11-30

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00135551 on ClinicalTrials.gov