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

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

Collaborators

Pozen

Inclusion and exclusion criteria

Location

Research Site

Overland Park, KS, United States

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

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1723&filename=CSR-D1120C00036.pdf
Download
CSR-D1120C00036.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles - Overland Park Kansas

1-800-292-5533

volunteer@quintiles.com

Investigators

Principal Investigator

Ralph Schutz

Quintiles Phase 1 Services