Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Recruitment status was Active, not recruiting
The purpose of this study is to compare an angiotensin II receptor antagonist (candesartan cilexetil– Blopress®) and a calcium channel blocker (amlodipine besilate– Norvasc®/Amlodin®) in terms of the incidence of cardiovascular events among high-risk hypertensive patients.
Drug: Candesartan cilexetil
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients|
- Sudden death: death of endogenous origin within 24 hours after acute onset
- Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack
- Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction
- Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event)
- Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery
- All deaths
- Involution of left ventricular hypertrophy (LVMI)
- Proportion of the subjects who withdrew from the allocated treatment
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||December 2005|
Hypertension continues to be a major public health issue in the world. To combat this problem, many antihypertensive drugs have been developed and proven effective at controlling blood pressure in the last half century. In recent decades, antihypertensive drugs have been shown to have cardiovascular benefits beyond the reduction of blood pressure, and the focus has shifted to clarification of these effects. Angiotensin II receptor antagonists and calcium channel blockers are the most widely used antihypertensive drugs in Japan. However, these two classes of drugs have not yet been compared with respect to their efficacy for treating cardiovascular events.
Comparison: Response-dependent dose titration and blinded assessment of endpoints in high risk hypertensive patients treated with either an angiotensin II receptor antagonist (candesartan cilexetil) compared to a third-generation calcium channel blocker (amlodipine besilate).
|Kyoto, Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan, 606-8501|
|Principal Investigator:||Takao Saruta, M.D.||Keio University|