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

Last updated: August 4, 2015
Sponsor: New Haven Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

Heart Disease

Vascular Diseases

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT02370680
NHP-ASP-102
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withat least 2 CVD risk factors (obese, smoker, ≥ 55 years of age, prior thrombotic event)

Exclusion

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 toimpaired drug absorption, clinically significant abnormal baseline ECG, history ofhepatitis, malignancy within the past five years, or HIV, history of alcohol or drugabuse.

Study Design

Total Participants: 41
Study Start date:
February 01, 2015
Estimated Completion Date:
July 31, 2015

Connect with a study center

  • Platelet and Thrombosis Research, LLC

    Baltimore, Maryland 21215
    United States

    Site Not Available

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