Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00125463|
Recruitment Status : Unknown
Verified April 2005 by The Japanese Society of Hypertension.
Recruitment status was: Active, not recruiting
First Posted : August 1, 2005
Last Update Posted : August 10, 2005
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Cardiovascular Diseases||Drug: Candesartan cilexetil||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients|
|Study Start Date :||September 2001|
|Study Completion Date :||December 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125463
|Kyoto, Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan, 606-8501|
|Principal Investigator:||Takao Saruta, M.D.||Keio University|