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

New Haven Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Disease

Treatments: Drug: Durlaza™; Drug: Aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02370680

NHP-ASP-102

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Durlaza™, 1 capsule

Experimental group

Description:

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

Treatment:

Drug: Durlaza™

Drug: Aspirin

Durlaza™, 2 capsules

Experimental group

Description:

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

Treatment:

Drug: Durlaza™

Drug: Aspirin