Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Haven Pharmaceuticals, Inc.
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Male or non-lactating, non-pregnant female subjects

• A history of Type 2 Diabetes and with history of at least one of the following:

Coronary Artery Disease, Peripheral Vascular Disease, or Ischemic Stroke, along with at least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)

Exclusion Criteria:

• Sensitivity to aspirin or any NSAID (nonsteroidal antiinflammatory drug),

• Evidence of uncontrolled or unstable cardio- or cerebrovascular disorder,

• Presence of uncontrolled or chronic medical illness, GI disorder or surgery leading to impaired drug absorption, clinically significant abnormal baseline ECG, history of hepatitis, malignancy within the past five years, or HIV, history of alcohol or drug abuse.