OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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 reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSCAR Study
• Collaborator: Japan Heart Foundation
• Treatments: Amlodipine; Angiotensin II Type 1 Receptor Blockers; Calcium; Calcium Channel Blockers; Calcium, Dietary; Olmesartan; Olmesartan Medoxomil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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