Benidipine-based Comparison of Angiotensin Receptors, β-blockers, or Thiazide Diuretics in Hypertensive Patients (COPE)
This study has been completed.
Sponsor:
Seiji Umemoto, M.D., Ph.D.
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
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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: Angiotensin receptor blockers Drug: β-blockers Drug: thiazide diuretics |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial |
Resource links provided by NLM:
Further study details as provided by COPE Trial Group:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 3501 |
| Study Start Date: | May 2003 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: angiotensin receptor blockers
benidipine+angiotensin receptor blockers, titlation scheme
|
Drug: Angiotensin receptor blockers
benidipine+angiotensin receptor blocker, titlation scheme
Other Name: benidipine, angiotensin receptor blockers
|
|
Active Comparator: β-blockers
benidipie+β-blockers, titlation scheme
|
Drug: β-blockers
benidipine+β-blockers, titlation scheme
Other Name: benidipine, β-blockers
|
|
Active Comparator: thiazide diuretics
benidipine+thiazide diuretics, titlation scheme
|
Drug: thiazide diuretics
benidipie+thiazide diuretics, titlation scheme
Other Name: benidipie, thiazide diuretics
|
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 | |
| Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine | |
| Ube, Yamaguchi, Japan, 755-8505 | |
Sponsors and Collaborators
Seiji Umemoto, M.D., Ph.D.
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
Additional Information:
Publications:
| Responsible Party: | Seiji Umemoto, M.D., Ph.D., Associate Professor, COPE Trial Group |
| ClinicalTrials.gov Identifier: | NCT00135551 History of Changes |
| Other Study ID Numbers: | copeadministrator |
| Study First Received: | August 24, 2005 |
| Last Updated: | February 19, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Vascular Diseases Diuretics Sodium Chloride Symporter Inhibitors Benidipine Angiotensin Receptor Antagonists Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Cardiovascular Agents Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on June 18, 2013