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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00125463
• Other study ID #: JSH-00001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 29, 2005
• Last updated: August 8, 2005
• Start date: September 2001
• Est. completion date: December 2005

Study information

• Verified date: April 2005
• Source: The Japanese Society of Hypertension
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3200
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

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 aß 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Drug:
• Candesartan cilexetil

Locations

Country	Name	City	State
Japan	Kyoto University	Kyoto	Yoshidakonoe-cho, Sakyo-ku, Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
The Japanese Society of Hypertension

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sudden death: death of endogenous origin within 24 hours after acute onset
Primary	Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack
Primary	Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction
Primary	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)
Primary	Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery
Secondary	All deaths
Secondary	Involution of left ventricular hypertrophy (LVMI)
Secondary	Proportion of the subjects who withdrew from the allocated treatment