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

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ClinicalTrials.gov Identifier: NCT02370680
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
New Haven Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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 Name: 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 Name: Bayer aspirin

Drug: Durlaza™
comparison of different numbers of capsules




Primary Outcome Measures :
  1. change in platelet aggregation [ Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints ]

Secondary Outcome Measures :
  1. Reactive Hyperemia Index [ Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints ]
  2. 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 ]

Other Outcome Measures:
  1. Serum Thromboxane [ Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints ]
  2. urinary metabolites of prostacyclin and thromboxane [ Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370680


Locations
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United States, Maryland
Platelet and Thrombosis Research, LLC
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
New Haven Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Paul Gurbel, MD Platelet Thrombosis Research, LLC

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Responsible Party: New Haven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02370680     History of Changes
Other Study ID Numbers: NHP-ASP-102
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

Keywords provided by New Haven Pharmaceuticals, Inc.:
Antiplatelet
Antiplatelet therapy
platelet turnover
high platelet turnover
platelet aggregation
cardiovascular disease
coronary artery disease
diabetes mellitus

Additional relevant MeSH terms:
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Aspirin
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics