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

• Status: Unknown status
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Japanese Society of Hypertension
• Treatments: Antihypertensive Agents; Candesartan; Candesartan cilexetil

Criteria

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