A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540

NCT01557335 | Completed Phase 1

• 1 other identifier: PA32540-111
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet Aggregation

Keywords

To evaluate adenosine diphosphate (ADP)-induced platelet aggregation

Outcome Measures

Primary Outcomes (1)

• Evaluate adenosine diphosphate (ADP)-induced platelet aggregation

  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).

  7 days

Secondary Outcomes (1)

• Evaluate arachidonic acid (AA)-induced platelet aggregation

  7 days

Study Arms (2)

Clopidogrel (Plavix®) and PA32540

EXPERIMENTAL

PA32540 and Clopidogrel (Plavix®) tablet, 10 hours post PA32540

Drug: Plavix® and PA32540

EC aspirin, EC omeprazole, Clopidogrel

ACTIVE COMPARATOR

Drug: EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)

Interventions

Plavix® and PA32540 DRUG

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)

Clopidogrel (Plavix®) and PA32540

EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®) DRUG

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

EC aspirin, EC omeprazole, Clopidogrel

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• POZEN: lead

Study Sites (1)

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

Location

Related Publications (1)

• Gurbel PA, Bliden KP, Fort JG, Jeong YH, Shuldiner A, Chai S, Gesheff T, Antonino M, Gesheff M, Zhang Y, Tantry US. Spaced administration of PA32540 and clopidogrel results in greater platelet inhibition than synchronous administration of enteric-coated aspirin and enteric-coated omeprazole and clopidogrel. Am Heart J. 2013 Feb;165(2):176-82. doi: 10.1016/j.ahj.2012.07.032. Epub 2012 Dec 4.

  PMID: 23351820 DERIVED

MeSH Terms

Interventions

Clopidogrel; Omeprazole

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Benzimidazoles

Study Officials

• Lisa Zimmerman

  POZEN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 19, 2012
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

US (1)