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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,501
benidipine+angiotensin receptor blocker, titlation scheme
benidipine+β-blockers, titlation scheme
benidipie+thiazide diuretics, titlation scheme
Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, Japan
A composite of fatal and non-fatal cardiovascular events.
Time frame: first event
Achievement of target blood pressure (< 140 mmHg/90 mmHg).
Time frame: time course
All-cause mortality.
Time frame: first event
Death from cardiovascular events.
Time frame: first event
Fatal and non-fatal cardiovascular events.
Time frame: first event
Hospitalization due to heart failure.
Time frame: first event
New onset of diabetes mellitus.
Time frame: first event
Safety (adverse events and adverse drug reaction).
Time frame: total number
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