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

August 4, 2015 updated by: New Haven Pharmaceuticals, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Platelet and Thrombosis Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in platelet aggregation
Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
During the 26-hour hospital stays, outcomes will be measured at various timepoints

Secondary Outcome Measures

Outcome Measure
Time Frame
Reactive Hyperemia Index
Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
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
Time Frame: participants are followed for approximately 40 to 65 days once they start study medication
participants are followed for approximately 40 to 65 days once they start study medication

Other Outcome Measures

Outcome Measure
Time Frame
Serum Thromboxane
Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
During the 26-hour hospital stays, outcomes will be measured at various timepoints
urinary metabolites of prostacyclin and thromboxane
Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
During the 26-hour hospital stays, outcomes will be measured at various timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Haven Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Paul Gurbel, MD, Platelet Thrombosis Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHP-ASP-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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