Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
NCT ID: NCT01515657
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2012-01-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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PL2200 Aspirin Capsules
Investigational drug arm; crossover design
PL2200 Aspirin Capsules
325 mg aspirin; once per day for 3 days
Immediate-Release Aspirin Tablets
Active comparator; crossover design
Immediate-Release Aspirin Tablets
325 mg aspirin; once per day for 3 days
Enteric-coated aspirin caplets
Active comparator; crossover design
Enteric-coated aspirin caplets
325 mg aspirin; once per day for 3 days
Interventions
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PL2200 Aspirin Capsules
325 mg aspirin; once per day for 3 days
Immediate-Release Aspirin Tablets
325 mg aspirin; once per day for 3 days
Enteric-coated aspirin caplets
325 mg aspirin; once per day for 3 days
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of 30-40 kg/m2
* Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of \> 6.4% and/or fasting plasma glucose of \>125 mg/dL or current anti-diabetic medication)
* AA-induced platelet aggregation response of \>60% within 3 hours prior to initial dose of study drug administration
Exclusion Criteria
* Previous history of vascular disease
* Patient requires insulin
* Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization
21 Years
79 Years
ALL
No
Sponsors
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PLx Pharma
INDUSTRY
Responsible Party
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Locations
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MedPace Clinical Pharmacology
Cincinnati, Ohio, United States
Countries
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References
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Bhatt DL, Grosser T, Dong JF, Logan D, Jeske W, Angiolillo DJ, Frelinger AL 3rd, Lei L, Liang J, Moore JE, Cryer B, Marathi U. Enteric Coating and Aspirin Nonresponsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol. 2017 Feb 14;69(6):603-612. doi: 10.1016/j.jacc.2016.11.050. Epub 2017 Jan 11.
Other Identifiers
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PL-ASA-004
Identifier Type: -
Identifier Source: org_study_id
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