Status:
UNKNOWN
Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Lead Sponsor:
The Japanese Society of Hypertension
Conditions:
Hypertension
Cardiovascular Diseases
Eligibility:
All Genders
25-85 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT00125463
Start Date
September 1 2001
End Date
December 1 2005
Last Update
August 10 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyoto University
Kyoto, Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan, 606-8501