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

Sponsor

New Haven Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02370680

Collaborator

(none)

Enrollment

Location

Arms

4.9

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Aspirin Drug: Durlaza™	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Durlaza™, 1 capsule Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit	Drug: Aspirin steady-state run-in prior to Durlaza treatment Other Names: Bayer aspirin Drug: Durlaza™ comparison of different numbers of capsules
Experimental: Durlaza™, 2 capsules 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	Drug: Aspirin steady-state run-in prior to Durlaza treatment Other Names: Bayer aspirin Drug: Durlaza™ comparison of different numbers of capsules

Arm

Intervention/Treatment

Experimental: Durlaza™, 1 capsule

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

Drug: Aspirin

steady-state run-in prior to Durlaza treatment

Other Names:

Bayer aspirin

Drug: Durlaza™

comparison of different numbers of capsules

Experimental: Durlaza™, 2 capsules

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

Drug: Aspirin

steady-state run-in prior to Durlaza treatment

Other Names:

Bayer aspirin

Drug: Durlaza™

comparison of different numbers of capsules

Outcome Measures

Primary Outcome Measures

change in platelet aggregation [During the 26-hour hospital stays, outcomes will be measured at various timepoints]

Secondary Outcome Measures

Reactive Hyperemia Index [During the 26-hour hospital stays, outcomes will be measured at various timepoints]
Safety as measured by the number and system class of adverse events reported in each treatment arm [participants are followed for approximately 40 to 65 days once they start study medication]

Other Outcome Measures

Serum Thromboxane [During the 26-hour hospital stays, outcomes will be measured at various timepoints]
urinary metabolites of prostacyclin and thromboxane [During the 26-hour hospital stays, outcomes will be measured at various timepoints]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.