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

Cardiovascular Disease Clinical Trial

— DURATION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370680
• Other study ID #: NHP-ASP-102
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2015
• Last updated: August 4, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: New Haven Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Aspirin
steady-state run-in prior to Durlaza treatment
• Durlaza™
comparison of different numbers of capsules

Locations

Country	Name	City	State
United States	Platelet and Thrombosis Research, LLC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
New Haven Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Thromboxane		During the 26-hour hospital stays, outcomes will be measured at various timepoints	No
Other	urinary metabolites of prostacyclin and thromboxane		During the 26-hour hospital stays, outcomes will be measured at various timepoints	No
Primary	change in platelet aggregation		During the 26-hour hospital stays, outcomes will be measured at various timepoints	No
Secondary	Reactive Hyperemia Index		During the 26-hour hospital stays, outcomes will be measured at various timepoints	No
Secondary	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	No