A Study Assessing Inhibition of Serum Thromboxane B2 Levels with PN400 and Low Dose Aspirin
Study identifier:D1120C00036
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels with PN 400 and Low dose Aspirin
Medical condition
platelet inhibition
Phase
Phase 1
Healthy volunteers
Yes
Study drug
PN400, ASA, Placebo
Sex
All
Actual Enrollment
40
Study type
Interventional
Age
50 Years - 75 Years
Date
Study Start Date: 01 Mar 2010
Primary Completion Date: 01 May 2010
Study Completion Date: 01 May 2010
Study design
Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Pozen
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 PN400 + ASA | Drug: PN400 naproxen 500 mg/esomeprazole 20 mg oral tablet Drug: ASA Asprin 81 mg enteric coated tablet Other Name: Asprin |
| Placebo Comparator: 2 Placebo + ASA | Drug: ASA Asprin 81 mg enteric coated tablet Other Name: Asprin |
Contacts
Investigators
Principal Investigator
Ralph Schutz
Quintiles Phase 1 Services
