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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125463
Recruitment Status : Unknown
Verified April 2005 by The Japanese Society of Hypertension.
Recruitment status was:  Active, not recruiting
First Posted : August 1, 2005
Last Update Posted : August 10, 2005
Information provided by:
The Japanese Society of Hypertension

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 incidence of cardiovascular events among high-risk hypertensive patients.

Condition or disease Intervention/treatment Phase
Hypertension Cardiovascular Diseases Drug: Candesartan cilexetil Phase 3

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 last half century. In recent decades, antihypertensive drugs have been shown to have cardiovascular benefits beyond the reduction of blood pressure, and the focus has shifted to clarification of these effects. Angiotensin II receptor antagonists and calcium channel blockers are the most widely used antihypertensive drugs in Japan. However, these two classes of drugs have not yet been compared with respect to their efficacy for treating cardiovascular events.

Comparison: Response-dependent dose titration and blinded assessment of endpoints in high risk hypertensive patients treated with either an angiotensin II receptor antagonist (candesartan cilexetil) compared to a third-generation calcium channel blocker (amlodipine besilate).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) Trial of Cardiovascular Events in High-Risk Hypertensive Patients
Study Start Date : September 2001
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Sudden death: death of endogenous origin within 24 hours after acute onset
  2. Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack
  3. Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction
  4. 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)
  5. Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery

Secondary Outcome Measures :
  1. All deaths
  2. Involution of left ventricular hypertrophy (LVMI)
  3. Proportion of the subjects who withdrew from the allocated treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00125463

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Kyoto University
Kyoto, Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan, 606-8501
Sponsors and Collaborators
The Japanese Society of Hypertension
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Principal Investigator: Takao Saruta, M.D. Keio University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00125463     History of Changes
Other Study ID Numbers: JSH-00001
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: August 10, 2005
Last Verified: April 2005
Keywords provided by The Japanese Society of Hypertension:
clinical trial
Candesartan Antihypertensive Survival Evaluation in Japan trial
candesartan cilexetil
amlodipine besilate
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vascular Diseases
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action