Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients

Inclusion Criteria: Systolic blood pressure (SBP) ≥140 mmHg in those <70 years old or ≥160 mmHg in those ≥70 years old or diastolic blood pressure (DBP) ≥90 mmHg in a sitting position on two consecutive measurements at clinic At least one of the following risk factors: SBP ≥180 mmHg or DBP ≥110 mmHg on two consecutive visits; Type 2 diabetes (fasting blood glucose ≥126 mg/dl, causal blood glucose ≥200 mg/dl, HbA1c ≥6.5%, 2 hours blood glucose on 75 g oral glucose tolerance test [OGTT] ≥200 mg/dl, or current treatment with hypoglycemic agent); History of cerebral hemorrhage, cerebral infarction, or transient ischemic attack until 6 months prior to the screening; Thickness of the posterior wall of left ventricle or thickness of the wall of interventricular septum ≥12 mm on echocardiography or Sv1＋Rv5 ≥35 mm on electrocardiography, angina pectoris, and a past history (≥6 months before giving informed consent) of myocardial infarction; Proteinuria ≥＋1 or renal impairment (serum creatinine ≥1.3 mg/dl) within 3 months at the time of giving informed consent; Arteriosclerotic peripheral arterial obstruction (Fontaine class ≥2); *Clinical diagnosis of Alzheimer's disease. Exclusion Criteria: SBP ≥200 mmHg or DBP ≥120 mmHg in a sitting position Type I diabetes mellitus History of myocardial infarction or cerebrovascular accidents within 6 months prior to the screening Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting (CABG) done within 6 months of screening or scheduled Current treatment for congestive cardiac failure (New York Heart Association [NYHA] functional class II or severer) or ejection fraction <40% Coronary artery disease requiring αβ blocker or calcium channel blocker Atrial fibrillation or atrial flutter Renal dysfunction (serum creatinine ≥3 mg/dl) Hepatic dysfunction (AST and/or ALT ≥100 IU/l) A history of malignant tumor within 5 years of enrollment or suspected Contraindication for candesartan cilexetil or amlodipine besilate Pregnancy, possible pregnancy, or plan to conceive a child within 5 years of enrollment Not suited to the clinical trial as judged by a collaborating physician Inability to give informed consent