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

February 19, 2012 updated by: Seiji Umemoto, M.D., Ph.D.

The Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3501

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients who are required a combination therapy with sitting systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
  • Outpatients aged over 40 years and less than 85 years (inclusive), regardless of sex.
  • Previously untreated patients or patients who are on other therapy, which can be converted to 4mg of benidipine.
  • Patients who can be treated with benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics.

Exclusion Criteria:

  • Seated systolic blood pressure ≥ 200 mmHg or seated diastolic blood pressure ≥ 120 mmHg.
  • Secondary hypertension.
  • Type I diabetes mellitus or type 2 diabetes on insulin treatment.
  • History of cerebrovascular disorder, myocardial infarction, angina pectoris, coronary angioplasty or coronary artery bypass graft surgery within 6 months prior to enrolment in the study.
  • Heart failure (New York Heart Association [NYHA] functional classification II, III or IV).
  • Chronic atrial fibrillation or atrial flutter.
  • Congenital heart disease or a history of rheumatic heart disease.
  • Severe peripheral arterial disease (Fontaine Class II, III or IV).
  • Serious liver dysfunction (AST or ALT ≥100 IU / l).
  • Serious renal dysfunction (serum creatinine ≥ 2mg/dl).
  • History of malignancy 5 years prior to study entry.
  • Pregnancy.
  • Compliance rate < 70% assessed by a patient interview.
  • Known hypersensitivity or contraindication to benidipine, angiotensin receptor blockers, β-blockers, and thiazide diuretics.
  • Other serious illness or significant abnormalities that the investigator judges inappropriate for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: angiotensin receptor blockers
benidipine+angiotensin receptor blockers, titlation scheme
Drug: Angiotensin receptor blockers
benidipine+angiotensin receptor blocker, titlation scheme
Other Names:
  • benidipine, angiotensin receptor blockers
Active Comparator: β-blockers
benidipie+β-blockers, titlation scheme
Drug: β-blockers
benidipine+β-blockers, titlation scheme
Other Names:
  • benidipine, β-blockers
Active Comparator: thiazide diuretics
benidipine+thiazide diuretics, titlation scheme
Drug: thiazide diuretics
benidipie+thiazide diuretics, titlation scheme
Other Names:
  • benidipie, thiazide diuretics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite of fatal and non-fatal cardiovascular events.
Time Frame: first event
first event
Achievement of target blood pressure (< 140 mmHg/90 mmHg).
Time Frame: time course
time course

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality.
Time Frame: first event
first event
Death from cardiovascular events.
Time Frame: first event
first event
Fatal and non-fatal cardiovascular events.
Time Frame: first event
first event
Hospitalization due to heart failure.
Time Frame: first event
first event
New onset of diabetes mellitus.
Time Frame: first event
first event
Safety (adverse events and adverse drug reaction).
Time Frame: total number
total number

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seiji Umemoto, M.D., Ph.D.

Collaborators

Yamaguchi University Hospital
The Japanese Society of Hypertension
Kyowa Hakko Kogyo Co., Ltd.

Investigators

  • Principal Investigator: Toshio Ogihara, MD, PhD, Department of Geriatric Medicine, Osaka University Graduate School of Medicine
  • Study Chair: Takao Saruta, MD, PhD, Department of Internal Medicine, Keio University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 19, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • copeadministrator

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Disease

Clinical Trials on Angiotensin receptor blockers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe