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

Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: Aspirin; Drug: Durlaza™

• Registration Number: NCT02370680
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durlaza™, 1 capsule	Aspirin	Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
Durlaza™, 1 capsule	Durlaza™	Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
Durlaza™, 2 capsules	Aspirin	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
Durlaza™, 2 capsules	Durlaza™	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

Primary Outcome Measures

Name	Time	Method
change in platelet aggregation	During the 26-hour hospital stays, outcomes will be measured at various timepoints

Secondary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index	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	participants are followed for approximately 40 to 65 days once they start study medication

Trial Locations

Locations (1)

Platelet and Thrombosis Research, LLC; 🇺🇸 Baltimore, Maryland, United States