Trial | NCT02370680  Report issue

Title

Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
Durability of Antiplatelet Effect of a Novel Extended-Release Formulation of Acetylsalicylic Acid, Durlaza in CVD (Cardiovascular Disease) Patients at Risk of High Platelet Turnover

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    41
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.
Study Started
Feb 28
2015
Primary Completion
Jul 31
2015
Study Completion
Jul 31
2015
Last Update
Aug 06
2015
Estimate

Drug Aspirin

steady-state run-in prior to Durlaza treatment

  • Other names: Bayer aspirin

Drug Durlaza™

comparison of different numbers of capsules

Durlaza™, 1 capsule Experimental

Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit

Durlaza™, 2 capsules Experimental

in a rollover with 10 subjects from the first arm, an aspirin run-in, followed by Durlaza™, two capsules QD, for 14 ± 4 days and an in-patient visit

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.
No Results Posted