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

This study has been completed.
Sponsor:
Collaborators:
The Japanese Society of Hypertension
Yamaguchi University Hospital
Kyowa Hakko Kogyo Co., Ltd.
Information provided by (Responsible Party):
Seiji Umemoto, M.D., Ph.D., COPE Trial Group
ClinicalTrials.gov Identifier:
NCT00135551
First received: August 24, 2005
Last updated: February 19, 2012
Last verified: February 2012

August 24, 2005
February 19, 2012
May 2003
May 2010   (final data collection date for primary outcome measure)
  • A composite of fatal and non-fatal cardiovascular events. [ Time Frame: first event ] [ Designated as safety issue: Yes ]
  • Achievement of target blood pressure (< 140 mmHg/90 mmHg). [ Time Frame: time course ] [ Designated as safety issue: Yes ]
  • 1) A composite of fatal and non-fatal cardiovascular events
  • 2) Achievement of target blood pressure (systolic blood pressure < 140 mmHg and diastolic blood pressure <90 mmHg).
  • 1. Sudden death (acute onset and intrinsic death within 24 h).
  • 2. Fatal or nonfatal stroke (new onset or recurrence).
  • 3. Fatal or nonfatal myocardial infarction (new onset or recurrence), hospitalization due to unstable angina, new onset of heart failure (Class II, III, or IV), sudden cardiac death.
  • 4. New onset or worsening of peripheral arterial disease.
  • 5. New onset or worsening of renal failure (as indicated by a serum creatinine level that is at least doubled to over 2 mg/dl), serum creatinine ≥ 4.0 mg/dl, renal dialysis or renal transplantation.
Complete list of historical versions of study NCT00135551 on ClinicalTrials.gov Archive Site
  • All-cause mortality. [ Time Frame: first event ] [ Designated as safety issue: Yes ]
  • Death from cardiovascular events. [ Time Frame: first event ] [ Designated as safety issue: Yes ]
  • Fatal and non-fatal cardiovascular events. [ Time Frame: first event ] [ Designated as safety issue: Yes ]
  • Hospitalization due to heart failure. [ Time Frame: first event ] [ Designated as safety issue: Yes ]
  • New onset of diabetes mellitus. [ Time Frame: first event ] [ Designated as safety issue: Yes ]
  • Safety (adverse events and adverse drug reaction). [ Time Frame: total number ] [ Designated as safety issue: Yes ]
  • 1. All-cause mortality.
  • 2. Death from cardiovascular events.
  • 3. Fatal and non-fatal cardiovascular events.
  • 4. Hospitalization due to heart failure.
  • 5. New onset of diabetes mellitus.
  • 6. Safety (adverse events and adverse drug reaction).
Not Provided
Not Provided
 
Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
  • Drug: Angiotensin receptor blockers
    benidipine+angiotensin receptor blocker, titlation scheme
    Other Name: benidipine, angiotensin receptor blockers
  • Drug: β-blockers
    benidipine+β-blockers, titlation scheme
    Other Name: benidipine, β-blockers
  • Drug: thiazide diuretics
    benidipie+thiazide diuretics, titlation scheme
    Other Name: benidipie, thiazide diuretics
  • Active Comparator: angiotensin receptor blockers
    benidipine+angiotensin receptor blockers, titlation scheme
    Intervention: Drug: Angiotensin receptor blockers
  • Active Comparator: β-blockers
    benidipie+β-blockers, titlation scheme
    Intervention: Drug: β-blockers
  • Active Comparator: thiazide diuretics
    benidipine+thiazide diuretics, titlation scheme
    Intervention: Drug: thiazide diuretics

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3501
November 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00135551
copeadministrator
Yes
Seiji Umemoto, M.D., Ph.D., COPE Trial Group
Seiji Umemoto, M.D., Ph.D.
  • The Japanese Society of Hypertension
  • Yamaguchi University Hospital
  • Kyowa Hakko Kogyo Co., Ltd.
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
COPE Trial Group
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP