A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540
Information source: POZEN
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Platelet Aggregation
Intervention: Plavix® and PA32540 (Drug); EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: POZEN Official(s) and/or principal investigator(s): Lisa Zimmerman, Study Director, Affiliation: POZEN
Summary
This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel
dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel
dosed concomitantly.
Clinical Details
Official title: A Randomized, Open-Label, Cross-Over, Study to Evaluate the Inhibitory Effect of Clopidogrel, EC Aspirin 81 mg and EC Omeprazole 40 mg All Dosed Concomitantly and PA32540 and Clopidogrel Dosed Separately on Platelet Aggregation in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluate adenosine diphosphate (ADP)-induced platelet aggregation
Secondary outcome: Evaluate arachidonic acid (AA)-induced platelet aggregation
Detailed description:
PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in
patients at risk for developing aspirin-associated gastric ulcers.
Aspirin 81 mg taken concomitantly with clopidogrel 75 mg as maintenance doses is standard of
care in some patients with cardiovascular disease. The combination of aspirin and
clopidogrel, however, significantly increases the risk for bleeding events. To mitigate
upper gastrointestinal bleeding events, these patients would require the use of a proton
pump inhibitor. For that reason, the reference arm in this study uses Prilosec® 40 mg as a
comparator - the same proton pump inhibitor at the same dose level.
The primary objective is to evaluate adenosine diphosphate (ADP)-induced platelet
aggregation following administration of clopidogrel, EC aspirin 81 mg and EC omeprazole 40
mg, all dosed concomitantly, and PA32540 and clopidogrel dosed separately
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or non-lactating, non-pregnant female subjects who are 40 years or older at the
time of initial dosing
- -Physical status within normal limits for age and consistent with observations at
Screening
- Able to understand and comply with study procedures required and able and willing to
provide written informed consent prior to any study procedures being performed
Exclusion Criteria:
- History of hypersensitivity, allergy or intolerance to omeprazole or other
proton-pump inhibitors (PPIs)
- History of hypersensitivity, allergy or intolerance to aspirin or any NSAID and/or a
history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- History of hypersensitivity or intolerance to clopidogrel
- History of hepatitis B or C, a positive test for hepatitis B surface antigen,
hepatitis C antibody, a history of human immunodeficiency virus (HIV) infection or
demonstration of HIV antibodies
- History of malignancy, treated or untreated, within the past five years, with the
exception of successfully treated basal cell or squamous cell carcinoma of - Evidence
of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the
Investigator's opinion, would endanger a subject if he/she were to participate in the
study
- Presence of an uncontrolled acute, or a chronic medical illness, e. g., GI disorder,
diabetes, hypertension, thyroid disorder, bleeding disorder, infection, which in the
Investigator's opinion would endanger a subject if he/she were to participate in the
study or interfere with the objective of this study
- Schizophrenia or bipolar disorder
- GI disorder or surgery leading to impaired drug absorption
- < 70% platelet aggregation at Screening
- Donation of blood or plasma within 4 weeks of the study
- PPI use or any enzyme inducing/inhibiting agents within 4 weeks prior to dosing
- Taking any antiplatelet drug within 2 weeks of the screening visit or during the
study, or more than two 325 mg doses of aspirin or more than 2 doses of any other
NSAIDs within 14 days prior to the screening visit
Locations and Contacts
Sinai Center for Thrombosis Research, Baltimore, Maryland 21215, United States
Additional Information
Starting date: November 2010
Last updated: March 15, 2012
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