The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.
Hypertension is one of the major risk factors of cardiovascular diseases. It is also important for elderly hypertensive patients to strictly reduce their blood pressures to prevent cardiovascular events. Although angiotensin II receptor blockers (ARBs) are increasingly used in antihypertensive treatment recently, few studies have been performed in Japan to assess the difference between high-dose ARB monotherapy and combination therapy of ARB with calcium channel blocker (CCB) in prevention of cardiovascular diseases for patients whose blood pressure is not well controlled by ARB monotherapy. OSCAR-study is a multicenter, active-controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (PROBE) design study. The dose administered is olmesartan medoxomil 20mg/day as ARB monotherapy in the 'Step 1' period. If the blood pressure is not adequately controlled and treatment is well tolerated then the dose is changed to olmesartan medoxomil 40mg/day in the high-dose ARB monotherapy group, or olmesartan medoxomil 20mg/day and a CCB in the combination therapy group in the 'Step 2' period. At least 500 patients will be enrolled in each group, and the follow-up duration will be 3 years. The primary objective is to compare the incidence of a composite of fatal and non-fatal cardiovascular events, and all cause mortality between the two treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
Olmesartan medoxomil 40mg/Day
Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)
Department of Cardiovascular Medicine Graduate School of Medical Science Kumamoto University
1-1-1 Honjyo, Kumamoto-City, Kumamoto, Japan
OSCAR-Study Data Center
ShinjukuParkTower30FN, 3-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack)
Time frame: 36 Months
Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia)
Time frame: 36 Months
Heart failure
Time frame: 36 Months
Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)
Time frame: 36 Months
Diabetic complications (nephropathy, retinopathy and neuropathy)
Time frame: 36 Months
Renal dysfunction (doubling of serum creatinine, end stage renal diseases)
Time frame: 36 Months
All cause mortality
Time frame: 36 Months
Development of each cardiovascular event
Time frame: 36 Months
Blood pressure change (systolic blood pressure [SBP], diastolic blood pressure [DBP], mean blood pressure [MBP]) at every observation point in the follow-up period
Time frame: 36 Months
Serious adverse events other than primary outcome events
Time frame: 36 Months
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