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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000267 |
Receipt No. | R000000336 |
Scientific Title | Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients |
Date of disclosure of the study information | 2005/10/30 |
Last modified on | 2006/11/01 |
Basic information | ||
Public title | Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients | |
Acronym | CASE-J | |
Scientific Title | Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients | |
Scientific Title:Acronym | CASE-J | |
Region |
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Condition | |||
Condition | Hypertension
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Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | 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.
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Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | 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 |
Key secondary outcomes | All deaths
Involution of left ventricular; hypertrophy (LVMI); Proportion of the subjects who withdrew from the allocated treatment |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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. |
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Interventions/Control_2 | 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. |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.SBP >=140 mmHg in those <70 years old or >=160 mmHg in those >=70 years old or DBP >=90 mmHg in a sitting position on two consecutive measurements at clinic
2.At least one of the following risk factors: a) SBP >=180 mmHg or DBP >=110 mmHg on two consecutive visits b) Type 2 diabetes (fasting blood glucose >=126 mg/dl, causal blood glucose >=200 mg/dl, HbA1c >=6.5%, 2h blood glucose on 75gOGTT >=200 mg/dl,or current treatment with hypoglycemic agent) c) History of cerebral hemorrhage, cerebral infarction, or transient ischemic attack until 6 months prior to the screening d) 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. e) Proteinuria >=+1 or renal impairment (serum creatinine >=1.3 mg/dl) within 3 months at the time of giving informed consent. f) Arteriosclerotic peripheral arterial obstruction (Fontaine class >=2) |
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Key exclusion 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 |
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Target sample size | 4000 |
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Name of lead principal investigator |
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Organization | Keio University | ||||||
Division name | School of Medicine | ||||||
Zip code | |||||||
Address | Sugimoto Building 2F, 1-12, Shinano-machi, Sinjyuku-ku, Tokyo | ||||||
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Organization | Kyoto University | ||||||
Division name | Epidemiological & Clinical Research Information Management | ||||||
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sakamoto@pbh.med.kyoto-u.ac.jp |
Sponsor | |
Institute | EBM Collaborating Research Center in Kyoto University |
Institute | |
Department |
Funding Source | |
Organization | The Japanese Society of Hypertension |
Organization | |
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Category of Funding Organization | Self funding |
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Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT00125463 |
Org. issuing International ID_1 | ClinicalTrials.gov |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Publication of results | Published |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000336 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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