Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients: Rationale, Design, and Methods

Valsartan in Elderly Isolated Systolic Hypertension (VALISH) Study: Rationale and Design

“…However, it is unclear what type of agents is favorable not only to reduce BP but also to protect against the incidence of cardiovascular events. In fact, in order to compare the protective effects against cardiovascular events in hypertensive patients, an investigator-initiated trial, the CASE-J study, is currently being performed in elderly hypertensive subjects in Japan (26).…”

The Optimal Target Blood Pressure for Antihypertensive Treatment in Japanese Elderly Patients with High-Risk Hypertension: A Subanalysis of the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial

“…High risk was defined as the presence of any one of the following factors: severe hypertension; type 2 diabetes; history of stroke or transient ischemic attack; history of myocardial infarction, angina pectoris, or left ventricular hypertrophy; renal dysfunction; or arteriosclerotic peripheral artery disease (16). The ages of the patients ranged from 20 to 84 years old.…”

“…After randomization, 2,364 patients were assigned to the candesartan group, and 2,364 patients were assigned to the amlodipine group (the mean of 3.2 years follow-up). The primary endpoint of the CASE-J trial was CV mortality and morbidity, which was a composite of sudden death; cerebrovascular events, including stroke or transient ischemic attack; cardiac events, including heart failure, angina pectoris, or acute myocardial infarction; renal events, including a serum creatinine concentration ≥ 4.0 mg/dL or a doubling of the serum creatinine concentration; and vascular events, including dissecting aortic aneurysm or arteriosclerotic occlusion of a peripheral artery (7,16). The CASE-J trial followed the CV events repeatedly until a patient died, and a 97.1% follow-up rate was achieved.…”

Informed Consent in the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial: A Survey of Collaborating Physicians

“…The Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) is a prospective, multicenter, open-label, randomized controlled trial to compare the effectiveness of an angiotensin II receptor antagonist (candesartan cilexetil) and a calcium channel blocker (amlodipine besilate) in reducing the incidence of cardiovascular events in high-risk hypertensive patients (4). Enrollment began in September 2001 and follow-up is to be completed in December 2005.…”

“…Enrollment began in September 2001 and follow-up is to be completed in December 2005. Written IC was taken before the patient was enrolled after explaining the following items: the objectives of the study, the duration of treatment, the random nature of the treatment allocation, the availability of alternative drugs, the possible adverse reactions of the treatment, the voluntary nature of participation, the fact that patients refusing to participate will not be disadvantaged in any way, the freedom to withdraw from the study at any time, the protective measures taken to ensure privacy, and the approval of the CASE-J trial by a university ethics committee (4).…”