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

NCT00125463 | Unknown Phase 3

• 1 other identifier: JSH-00001
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Diseases

Keywords

Hypertension; clinical trial; Candesartan Antihypertensive Survival Evaluation in Japan trial; candesartan cilexetil; amlodipine besilate

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• All deaths

• Involution of left ventricular hypertrophy (LVMI)

• Proportion of the subjects who withdrew from the allocated treatment

Interventions

Candesartan cilexetil DRUG

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Japanese Society of Hypertension: lead

Study Sites (1)

Kyoto University

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

Location

Related Publications (2)

• 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.

  PMID: 14717341 BACKGROUND

• 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.

  PMID: 18971535 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Takao Saruta, M.D.

  Keio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 1, 2005
• Study Start: September 1, 2001
• Study Completion: December 1, 2005
• Last Updated: August 10, 2005

Record last verified: 2005-04

Locations

JP (1)