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The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) Trial

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: COPE Trial Group
The Japanese Society of Hypertension
Yamaguchi University Hospital
Kyowa Hakko Kogyo Co., Ltd.
Information provided by: COPE Trial Group
ClinicalTrials.gov Identifier: NCT00135551
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Drug: Benidipine hydrochloride
Drug: Angiotensin receptor blockers
Drug: β-blockers
Drug: Thiazide diuretics
Phase IV

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Benidipine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) Trial

Further study details as provided by COPE Trial Group:

Primary Outcome Measures:
  • A composite of fatal and non-fatal cardiovascular events.
  • Achievement of target blood pressure (< 140 mmHg/90 mmHg).

Secondary Outcome Measures:
  • All-cause mortality.
  • Death from cardiovascular events.
  • Fatal and non-fatal cardiovascular events.
  • Hospitalization due to heart failure.
  • New onset of diabetes mellitus.
  • Safety (adverse events and adverse drug reaction).

Estimated Enrollment:   3000
Study Start Date:   May 2003

  Eligibility
Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135551

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

Sponsors and Collaborators
COPE Trial Group
The Japanese Society of Hypertension
Yamaguchi University Hospital
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    
  More Information


Click here for more information about this study (in Japanese): The Combination Therapy of Hypertension to Prevent Cardiovascular Events (COPE) Trial  This link exits the ClinicalTrials.gov site
 
Japanese Society of Hypertension  This link exits the ClinicalTrials.gov site
 
Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine  This link exits the ClinicalTrials.gov site
 
Department of Geriatric Medicine, Osaka University Graduate School of Medicine  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   copeadministrator
First Received:   August 24, 2005
Last Updated:   March 5, 2007
ClinicalTrials.gov Identifier:   NCT00135551
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by COPE Trial Group:
Hypertension  
Multicenter clinical trial  
PROBE  
Combination therapy
Benidipine
Essential Hypertension

Study placed in the following topic categories:
Vascular Diseases
Essential hypertension
Benidipine
Hypertension

Additional relevant MeSH terms:
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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