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