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HypertensionPhase 3NCT00125463

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

A Phase 3 study testing Candesartan cilexetil in people with Hypertension and Cardiovascular Diseases, run by The Japanese Society of Hypertension at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 85 years
Conditions the study is for
Hypertension, Cardiovascular Diseases
What is being tested?
Candesartan cilexetil
How many people
3,200 participants
Where
1 siteJapan
Study dates
Sep 2001to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Kyoto University

    Kyoto, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501

Other trials in Japan

About this study

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.

Read 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 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).

Being tested
Candesartan cilexetil
Keywords
Hypertension, clinical trial, Candesartan Antihypertensive Survival Evaluation in Japan trial, candesartan cilexetil, amlodipine besilate
Medical subject headings
Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Candesartan cilexetilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (3)

  1. All deaths

  2. Involution of left ventricular hypertrophy (LVMI)

  3. Proportion of the subjects who withdrew from the allocated treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2005 (estimated)
  2. Study startSep 2001
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00125463
Sponsor's protocol ID
JSH-00001
Status last verified
Apr 2005
First submitted
29 Jul 2005
Last updated
10 Aug 2005
Results posted
No

Publications

  • Fukui T, Rahman M, Hayashi K, Takeda K, Higaki J, Sato T, Fukushima M, Sakamoto J, Morita S, Ogihara T, Fukiyama K, Fujishima M, Saruta T; CASE-J Study Group. Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial of cardiovascular events in high-risk hypertensive patients: rationale, design, and methods. Hypertens Res. 2003 Dec;26(12):979-90. doi: 10.1291/hypres.26.979.

    PubMed 14717341

  • Ogihara T, Nakao K, Fukui T, Fukiyama K, Fujimoto A, Ueshima K, Oba K, Shimamoto K, Matsuoka H, Saruta T; CASE-J Trial Group. The optimal target blood pressure for antihypertensive treatment in Japanese elderly patients with high-risk hypertension: a subanalysis of the Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J) trial. Hypertens Res. 2008 Aug;31(8):1595-601. doi: 10.1291/hypres.31.1595.

    PubMed 18971535

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Candesartan cilexetil in people with Hypertension and Cardiovascular Diseases, run by The Japanese Society of Hypertension at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sudden death: death of endogenous origin within 24 hours after acute onset. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00125463, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2005; AzTrials last refreshed its copy on 8 Nov 2026.

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