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Completed

NCT Number: NCT00135551

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

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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

Ube, Yamaguchi, 755-8505, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin Receptor Blockers

Drug

benidipine+angiotensin receptor blocker, titlation scheme

Other names: benidipine, angiotensin receptor blockers

β-blockers

Drug

benidipine+β-blockers, titlation scheme

Other names: benidipine, β-blockers

Thiazide diuretics

Drug

benidipie+thiazide diuretics, titlation scheme

Other names: benidipie, thiazide diuretics

Primary outcomes

  1. A composite of fatal and non-fatal cardiovascular events.

    Time frame: first event

  2. Achievement of target blood pressure (< 140 mmHg/90 mmHg).

    Time frame: time course

Secondary outcomes

  1. All-cause mortality.

    Time frame: first event

  2. Death from cardiovascular events.

    Time frame: first event

  3. Fatal and non-fatal cardiovascular events.

    Time frame: first event

  4. Hospitalization due to heart failure.

    Time frame: first event

  5. New onset of diabetes mellitus.

    Time frame: first event

  6. Safety (adverse events and adverse drug reaction).

    Time frame: total number

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

The Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial

Acronym: COPE

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Aug 26, 2005
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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