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A Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN400 and Low Dose Aspirin

This study has been completed.
Sponsor:
Collaborator:
POZEN
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01094483
First received: March 25, 2010
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.


Condition Intervention Phase
Platelet Inhibition
Drug: PN400
Drug: ASA
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacodynamic: Mean percent inhibition of serum thromboxane B2 [ Time Frame: measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2 ] [ Designated as safety issue: No ]
  • Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events [ Time Frame: during approx 6 week study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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
Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stable without clinically significant disease

Exclusion Criteria:

  • Use of NSAID within 2 weeks
  • Type 1 or 2 DM
  • GI disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094483

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
POZEN
Investigators
Principal Investigator: Ralph Schutz, MD Quintiles Phase 1 Services
Study Director: Catherine Datto, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01094483     History of Changes
Other Study ID Numbers: D1120C00036
Study First Received: March 25, 2010
Last Updated: December 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Thromboxane B2

ClinicalTrials.gov processed this record on November 24, 2014