Length of Effect of Extended Release Aspirin on Platelets in Patients With Diabetes and Heart Disease
NCT ID: NCT02370680
Last Updated: 2015-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2015-02-28
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Durlaza™, 1 capsule
Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
Aspirin
steady-state run-in prior to Durlaza treatment
Durlaza™
comparison of different numbers of capsules
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
Aspirin
steady-state run-in prior to Durlaza treatment
Durlaza™
comparison of different numbers of capsules
Interventions
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Aspirin
steady-state run-in prior to Durlaza treatment
Durlaza™
comparison of different numbers of capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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New Haven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Gurbel, MD
Role: PRINCIPAL_INVESTIGATOR
Platelet Thrombosis Research, LLC
Locations
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Platelet and Thrombosis Research, LLC
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NHP-ASP-102
Identifier Type: -
Identifier Source: org_study_id
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