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

NCT02370680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-08-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Aspirin

steady-state run-in prior to Durlaza treatment

DRUG

Durlaza™

comparison of different numbers of capsules

Sponsors & Collaborators

  • New Haven Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Gurbel, MD · Platelet Thrombosis Research, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370680 on ClinicalTrials.gov