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Trial record 57 of 1302 for:    ASPIRIN AND Platelet Aggregation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE February 11, 2015
First Posted Date  ICMJE February 25, 2015
Last Update Posted Date August 6, 2015
Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
change in platelet aggregation [ Time Frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02370680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Reactive Hyperemia Index [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2015)
  • Serum Thromboxane [ Time Frame: 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE
  • Drug: Aspirin
    steady-state run-in prior to Durlaza treatment
    Other Name: Bayer aspirin
  • Drug: Durlaza™
    comparison of different numbers of capsules
Study Arms  ICMJE
  • Experimental: Durlaza™, 1 capsule
    Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
    Interventions:
    • Drug: Aspirin
    • Drug: Durlaza™
  • 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
    Interventions:
    • Drug: Aspirin
    • Drug: Durlaza™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2015)
41
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
40
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02370680
Other Study ID Numbers  ICMJE NHP-ASP-102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New Haven Pharmaceuticals, Inc.
Study Sponsor  ICMJE New Haven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Gurbel, MD Platelet Thrombosis Research, LLC
PRS Account New Haven Pharmaceuticals, Inc.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP