UMIN ID: C000000267
Registered date:30/10/2005
Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension |
| Date of first enrollment | 2001/09/01 |
| Target sample size | 4000 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Candesartan cilexetil (Blopress®) administered orally at a dose of 4–8 mg/day. When necessary, the dose was increased up to 12 mg/day. However, in patients with renal impairment, the drug was started from 2 mg/day and increased up to 8 mg/ day when necessary. The targets of BP control are as follows, <60age:SBP<130 DBP<85 60s:SBP<140 DBP<90 70s:SBP<150 DBP<90 80s:SBP<160 DBP<90 Following randomization, patients will be monitored with the appropriate frequency as judged by the collaborating physicians. The dose of the assigned drug can be gradually increased up to the maximum dosage (for candesartan, 12 mg/day) to achieve the therapeutic goals. If not achieved by the maximum dosage of each drug, any antihypertensive drugs other than the angiotensin II receptor antagonist, the calcium channel blocker, or ACE inhibitors can be added. Amlodipine besilate (Norvasc®/ Amlodin®) administered orally at a dose of 2.5–5 mg/day and increased up to 10 mg/day when necessary. The targets of BP control are as follows, <60age:SBP<130 DBP<85 60s:SBP<140 DBP<90 70s:SBP<150 DBP<90 80s:SBP<160 DBP<90 Following randomization, patients will be monitored with the appropriate frequency as judged by the collaborating physicians. The dose of the assigned drug can be gradually increased up to the maximum dosage (for amlodipine, 10 mg/day) to achieve the therapeutic goals. If not achieved by the maximum dosage of each drug, any antihypertensive drugs other than the angiotensin II receptor antagonist, the calcium channel blocker, or ACE inhibitors can be added. |
Outcome(s)
| Primary Outcome | Sudden death: death of endogenous origin within 24 hours after acute onset; Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack ; Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction; Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event); Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery |
|---|---|
| Secondary Outcome | All deaths Involution of left ventricular; hypertrophy (LVMI); Proportion of the subjects who withdrew from the allocated treatment |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.SBP ≥200 mmHg or DBP ≥120 mmHg in a sitting position 2.Type I diabetes mellitus 3.History of myocardial infarction or cerebrovascular accidents within 6 months prior to the screening 4.PTCA or CABG done within 6 months of screening or scheduled 5.Current treatment for congestive cardiac failure (NYHA functional class II or severer) or ejection fraction <40% 6.Coronary artery disease requiring beta blocker or calcium channel blocker 7.Atrial fibrillation or atrial flutter 8.Renal dysfunction (serum creatinine ≥3 mg/dl) 9.Hepatic dysfunction (AST and/or ALT ≥100 IU/l) 10.A history of malignant tumor within 5 years of enrollment or suspected 11.Contraindication for candesartan cilexetil or amlodipine besilate 12.Pregnancy, possible pregnancy, or plan to conceive a child within 5 years of enrollment 13.Not suited to the clinical trail as judged by a collaborating physician 14.Inability to give informed consent |
Related Information
| Primary Sponsor | EBM Collaborating Research Center in Kyoto University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Japanese Society of Hypertension |
| Secondary ID(s) | NCT00125463 |
Contact
| public contact | |
| Name | Junichi Sakamoto |
| Address | Japan |
| Telephone | |
| sakamoto@pbh.med.kyoto-u.ac.jp | |
| Affiliation | Kyoto University Epidemiological & Clinical Research Information Management |
| scientific contact | |
| Name | Takao Saruta |
| Address | Sugimoto Building 2F, 1-12, Shinano-machi, Sinjyuku-ku, Tokyo Japan |
| Telephone | |
| Affiliation | Keio University School of Medicine |