OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Cardiovascular Diseases |
Drug: Olmesartan medoxomil Drug: Calcium channel blockers (amlodipine, azelnidipine) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk |
- 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 ] [ Designated as safety issue: No ]
- Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Heart failure [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Diabetic complications (nephropathy, retinopathy and neuropathy) [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Renal dysfunction (doubling of serum creatinine, end stage renal diseases) [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- Development of each cardiovascular event [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Serious adverse events other than primary outcome events [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | August 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
High-dose ARB monotherapy
|
Drug: Olmesartan medoxomil
Olmesartan medoxomil 40mg/Day
|
|
Active Comparator: 2
Combination therapy of ARB with Calcium Channel Blocker
|
Drug: Calcium channel blockers (amlodipine, azelnidipine)
Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)
|
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 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.
Eligibility| Ages Eligible for Study: | 65 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Japan | |
| Department of Cardiovascular Medicine Graduate School of Medical Science Kumamoto University | |
| 1-1-1 Honjyo, Kumamoto-City, Kumamoto, Japan, 860-8556 | |
| OSCAR-Study Data Center | |
| ShinjukuParkTower30FN, 3-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1030 | |
| Study Chair: | Kikuo Arakawa, MD | Emeritus Professor Fukuoka University, Fukuoka, Japan |
More Information
Additional Information:
No publications provided by OSCAR Study
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ogawa Hisao, Kumamoto University Graduate School of Medical Science |
| ClinicalTrials.gov Identifier: | NCT00134160 History of Changes |
| Other Study ID Numbers: | 15-April-2005 |
| Study First Received: | August 22, 2005 |
| Last Updated: | October 3, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by OSCAR Study:
|
Aged Hypertension Cardiovascular Diseases Angiotensin II Type 1 Receptor Blockers |
Calcium Channel Blockers Combination Drug Therapy Diabetes Mellitus Type 2 |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Vascular Diseases Calcium, Dietary Calcium Channel Blockers Amlodipine Olmesartan medoxomil Olmesartan Angiotensin II Type 1 Receptor Blockers Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on October 16, 2012
