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OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study

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ClinicalTrials.gov Identifier: NCT00134160
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : October 5, 2010
Sponsor:
Collaborator:
Japan Heart Foundation
Information provided by:
OSCAR Study

Tracking Information
First Submitted Date  ICMJE August 22, 2005
First Posted Date  ICMJE August 24, 2005
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE August 2005
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • 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 ]
  • Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) [ Time Frame: 36 Months ]
  • Heart failure [ Time Frame: 36 Months ]
  • Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) [ Time Frame: 36 Months ]
  • Diabetic complications (nephropathy, retinopathy and neuropathy) [ Time Frame: 36 Months ]
  • Renal dysfunction (doubling of serum creatinine, end stage renal diseases) [ Time Frame: 36 Months ]
  • All cause mortality [ Time Frame: 36 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
  • 1) A composite of fatal and non-fatal cardiovascular events
  • (1) Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of ndetermined etiology and transient ischemic attack)
  • (2) Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia)
  • (3) Heart failure
  • (4) Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases)
  • (5) Diabetic complications (nephropathy, retinopathy and neuropathy)
  • (6) Renal dysfunction (doubling of serum creatinine, end stage renal diseases)
  • 2) All cause mortality
Change History Complete list of historical versions of study NCT00134160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • Development of each cardiovascular event [ Time Frame: 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 ]
  • Serious adverse events other than primary outcome events [ Time Frame: 36 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2005)
  • 1) Development of each cardiovascular event
  • 2) Blood pressure change (SBP, DBP, MBP) at every observation point in the follow-up period
  • 3) Serious adverse events other than primary outcome events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study
Official Title  ICMJE 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
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 reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hypertension
  • Cardiovascular Diseases
Intervention  ICMJE
  • Drug: Olmesartan medoxomil
    Olmesartan medoxomil 40mg/Day
  • Drug: Calcium channel blockers (amlodipine, azelnidipine)
    Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)
Study Arms  ICMJE
  • Active Comparator: 1
    High-dose ARB monotherapy
    Intervention: Drug: Olmesartan medoxomil
  • Active Comparator: 2
    Combination therapy of ARB with Calcium Channel Blocker
    Intervention: Drug: Calcium channel blockers (amlodipine, azelnidipine)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 22, 2005)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 84 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00134160
Other Study ID Numbers  ICMJE 15-April-2005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ogawa Hisao, Kumamoto University Graduate School of Medical Science
Study Sponsor  ICMJE OSCAR Study
Collaborators  ICMJE Japan Heart Foundation
Investigators  ICMJE
Study Chair: Kikuo Arakawa, MD Emeritus Professor Fukuoka University, Fukuoka, Japan
PRS Account OSCAR Study
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP