A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Platelet Aggregation |
Drug: Plavix® and PA32540 Drug: EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Evaluate adenosine diphosphate (ADP)-induced platelet aggregation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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.
The endpoint measure is IPA (Individual Platelet Aggregation)at day 7 and PA0 is the platelet aggregation at baseline. The IPA will be analyzed using analyses of variance (ANOVA).
- Evaluate arachidonic acid (AA)-induced platelet aggregation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To evaluate arachidonic acid (AA)-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.
The secondary endpoint is the IPA (Individual Platelet Aggregation) and will be analyzed using the same methodology as the primary endpoint.
| Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clopidogrel (Plavix®) and PA32540
PA32540 and Clopidogrel (Plavix®) tablet, 10 hours post PA32540
|
Drug: Plavix® and PA32540
one Plavix® 300 mg loading dose in the PM of Day 1 one Plavix® 75 mg maintenance dose in the PM of Days 2-7 PA32540(delayed release aspirin 325 mg plus immediate release omeprazole 40 mg)
|
| Active Comparator: EC aspirin, EC omeprazole, Clopidogrel |
Drug: EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)
One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 300 mg (loading dose) all One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 75 mg (maintenance dose) all taken concomitantly in the AM of Days 2-7
|
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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided by POZEN
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | POZEN |
| ClinicalTrials.gov Identifier: | NCT01557335 History of Changes |
| Other Study ID Numbers: | PA32540-111 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by POZEN:
|
To evaluate adenosine diphosphate (ADP)-induced platelet aggregation |
Additional relevant MeSH terms:
|
Aspirin Ticlopidine Clopidogrel Omeprazole Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Anti-Ulcer Agents Gastrointestinal Agents Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents |
ClinicalTrials.gov processed this record on June 18, 2013