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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00501059 |
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied. However, the overall risk level of the study populations was low (< 10% 10-year). The current study is designed to proof the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk (20-30% 10-year) of cardiovascular disease. Subjects are treated in a standard care setting and may receive treatment of the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.
Condition | Intervention | Phase |
---|---|---|
Moderate Risk of CVD |
Drug: Aspirin (Acetylsalicylic acid, BAYE4465) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease |
Estimated Enrollment: | 12000 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
100 mg enteric-coated Acetylsalicyclic
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Arm 2: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12198, EudraCT 2006-003622-29 |
Study First Received: | July 12, 2007 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00501059 |
Health Authority: | United States: Food and Drug Administration |
Primary prevention of coronary heart disease Stroke and cardiovascular death Aspirin |
Coronary Disease Death Heart Diseases Aspirin |
Cerebral Infarction Stroke Coronary Artery Disease |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Hematologic Agents Physiological Effects of Drugs Enzyme Inhibitors Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Fibrin Modulating Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Platelet Aggregation Inhibitors Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |