Study to Evaluate the Interaction Between Aspirin and Nexium

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01199328
First received: September 9, 2010
Last updated: November 18, 2010
Last verified: November 2010

September 9, 2010
November 18, 2010
September 2010
November 2010   (final data collection date for primary outcome measure)
Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers [ Time Frame: Ongoing throughout the study from consent through withdrawal ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01199328 on ClinicalTrials.gov Archive Site
  • Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline [ Time Frame: Ongoing throughout the study from consent through withdrawal ] [ Designated as safety issue: No ]
  • Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin [ Time Frame: Ongoing throughout the study from consent through withdrawal ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Interaction Between Aspirin and Nexium
A Phase I, Open, Two-way Crossover, Drug-drug Interaction Study Evaluating the Effect of Esomeprazole on the Pharmacodynamics of Acetylsalicylic Acid After 5 Days of Treatment

The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Aspirin
    81mg Tablet oral, once daily
  • Drug: Esomeprazole
    20 mg Tablet oral, once daily
    Other Name: Nexium
  • Active Comparator: 1
    Aspirin 81 mg
    Intervention: Drug: Aspirin
  • Active Comparator: 2
    Esomeprazole 20mg/aspirin 81mg
    Interventions:
    • Drug: Aspirin
    • Drug: Esomeprazole
Andersson T, Morrison D, Nagy P, Pisupati J, Schettler J, Warner TD. Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):217-24. doi: 10.2165/11634280-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision informed consent prior to any study specific procedures.
  • Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture.
  • Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control:
  • Continuously practice abstinence during screening and throughout the duration of the study
  • Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives.
  • Have a body mass index (BMI) between 19 and 30 kg/m2
  • No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
  • Previous enrolment or randomisation in the present study.
  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease
  • History or presence of clinically significant gastrointestinal e.e. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
  • Any clinically significant illness within 4 weeks of the first administration of investigational product.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199328
D961FC00011
No
MDS, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Dennis N Morrison, MD Bio-Kinetic Clinical Applications
Study Director: Tore Lind AstraZeneca
Study Chair: Lynne Durborow AstraZeneca
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP