OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study

October 3, 2010 updated by: OSCAR Study

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kumamoto
      • 1-1-1 Honjyo, Kumamoto-City, Kumamoto, Japan, 860-8556
        • Department of Cardiovascular Medicine Graduate School of Medical Science Kumamoto University
    • Tokyo
      • ShinjukuParkTower30FN, 3-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan, 163-1030
        • OSCAR-Study Data Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 84 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
36 Months
Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia)
Time Frame: 36 Months
36 Months
Heart failure
Time Frame: 36 Months
36 Months
Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)
Time Frame: 36 Months
36 Months
Diabetic complications (nephropathy, retinopathy and neuropathy)
Time Frame: 36 Months
36 Months
Renal dysfunction (doubling of serum creatinine, end stage renal diseases)
Time Frame: 36 Months
36 Months
All cause mortality
Time Frame: 36 Months
36 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of each cardiovascular event
Time Frame: 36 Months
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
36 Months
Serious adverse events other than primary outcome events
Time Frame: 36 Months
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSCAR Study

Collaborators

Japan Heart Foundation

Investigators

  • Study Chair: Kikuo Arakawa, MD, Emeritus Professor Fukuoka University, Fukuoka, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

October 5, 2010

Last Update Submitted That Met QC Criteria

October 3, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-April-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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