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