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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 25, 2010
Last updated: December 6, 2010
Last verified: December 2010
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 (Participant, 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

Resource links provided by NLM:

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 ]
  • Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events [ Time Frame: during approx 6 week study period ]

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


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01094483

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca Identifier: NCT01094483     History of Changes
Other Study ID Numbers: D1120C00036
Study First Received: March 25, 2010
Last Updated: December 6, 2010

Keywords provided by AstraZeneca:
Thromboxane B2

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on April 27, 2017