Status:
COMPLETED
OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study
Lead Sponsor:
OSCAR Study
Collaborating Sponsors:
Japan Heart Foundation
Conditions:
Hypertension
Cardiovascular Diseases
Eligibility:
All Genders
65-84 years
Phase:
PHASE4
Brief Summary
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 reduci...
Detailed Description
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 even...
Eligibility Criteria
Inclusion
- Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex
- Current antihypertensive treatment with monotherapy
- SBP ≥ 140mmHg or DBP ≥ 90mmHg in a sitting position on two measurements on two clinic visits
- At least one of the following risk factors:
- Diabetes mellitus Type 2;
- History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent);
- Diagnosis of asymptomatic cerebrovascular disease;
- History of myocardial infarction (more than 6 months before giving informed consent);
- Diagnosis of angina pectoris or heart failure (New York Heart Association \[NYHA\] functional classification I or II);
- Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum ≥ 12mm on echocardiography or Sv1+Rv5 ≥ 35mm on electrocardiography before informed consent);
- Diagnosis of aortic aneurysm;
- History of aortic dissection (more than 6 months before giving informed consent);
- Diagnosis of arteriosclerotic peripheral arterial obstruction (Fontaine classification from 2 to 4);
- Serum creatinine: 1.2-2.5mg/dL (male); 1.0-2.5mg/dL (female);
- Proteinuria: ≥ +1 (or ≥ 0.3g/g･Cr. estimated from 24-hour urine collection or random urinary protein corrected by urine creatinine).
Exclusion
- Secondary hypertension or malignant hypertension
- Heart failure (NYHA functional classification III or IV)
- Required treatment for malignant tumor
- Serious liver or renal dysfunction (serum creatinine \> 2.5mg/dL or with dialysis treatment)
- Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, β-blockers, thiazide diuretics, etc.)
- History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers
- Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00134160
Start Date
August 1 2005
End Date
May 1 2010
Last Update
October 5 2010
Active Locations (2)
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1
Department of Cardiovascular Medicine Graduate School of Medical Science Kumamoto University
1-1-1 Honjyo, Kumamoto-City, Kumamoto, Japan, 860-8556
2
OSCAR-Study Data Center
ShinjukuParkTower30FN, 3-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1030