Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial

UMIN ID: UMIN000001152

Registered date:12/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Outpatients who are required a combination therapy with sitting systolic blood pressure >=140 mmHg or diastolic blood pressure>=90 mmHg
• Date of first enrollment: 2003/04/01
• Target sample size: 3000
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

benidipine + angiotensin receptor blocker
benidipine + beta-blocker
benidipine + thiazide diuretic

Outcome(s)

• Primary Outcome: 1)A composite of fatal and non-fatal cardiovascular events (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 2)Achievement of target blood pressure (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg)serious and non-serious cardiovascular events
• Secondary Outcome: (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)

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1. Seated systolic blood pressure >=200 mmHg or seated diastolic blood pressure >=120 mmHg 2. Secondary hypertension 3. Type 1 diabetes mellitus or type 2 diabetes on insulin treatment 4. 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 5. Heart failure (NYHA functional classification II, III or IV) 6. Congenital heart disease or a history of rheumatic heart disease 7. Chronic atrial fibrillation or atrial flutter 8 Serious liver dysfunction (AST or ALT >=100 IU/l) or Serious renal dysfunction (serum creatinine >=2 mg/dl) 9. Severe peripheral arterial disease (Fontaine Class II, III or IV) 10. History of malignancy 5 years prior to study entry 11. Pregnancy 12. Compliance rate <70% assessed by a patient interview 13. Known hypersensitivity or contraindication to benidipine, angiotensin receptor blockers,beta-blockers, and thiazide diuretics 14. Other serious illness or significant abnormalities that the investigator judges inappropriate for the study

Related Information

• Primary Sponsor: COPE Trial Group
• Secondary Sponsor: The Japanese Society of Hypertension
• Source(s) of Monetary Support: Kyowa Hakko Kogyo Co.,
• Secondary ID(s): NCT00135551