OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134160
• Other study ID #: 15-April-2005
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2005
• Last updated: October 3, 2010
• Start date: August 2005
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: OSCAR Study
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 84 Years

Eligibility

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, ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension

Intervention

Drug:
• Olmesartan medoxomil
Olmesartan medoxomil 40mg/Day
• Calcium channel blockers (amlodipine, azelnidipine)
Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)

Locations

Country	Name	City	State
Japan	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

Sponsors (2)

Lead Sponsor	Collaborator
OSCAR Study	Japan Heart Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		36 Months	No
Primary	Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia)		36 Months	No
Primary	Heart failure		36 Months	No
Primary	Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)		36 Months	No
Primary	Diabetic complications (nephropathy, retinopathy and neuropathy)		36 Months	No
Primary	Renal dysfunction (doubling of serum creatinine, end stage renal diseases)		36 Months	No
Primary	All cause mortality		36 Months	No
Secondary	Development of each cardiovascular event		36 Months	No
Secondary	Blood pressure change (systolic blood pressure [SBP], diastolic blood pressure [DBP], mean blood pressure [MBP]) at every observation point in the follow-up period		36 Months	No
Secondary	Serious adverse events other than primary outcome events		36 Months	No