Trials / Completed
CompletedNCT02370680
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- New Haven Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aspirin | steady-state run-in prior to Durlaza treatment |
| DRUG | Durlaza™ | comparison of different numbers of capsules |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2015-02-25
- Last updated
- 2015-08-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02370680. Inclusion in this directory is not an endorsement.