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An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel

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ClinicalTrials.gov Identifier: NCT01210339
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 27, 2010
First Posted Date  ICMJE September 28, 2010
Last Update Posted Date October 7, 2011
Study Start Date  ICMJE November 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
  • The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done before treatment period 1. ]
  • The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done after treatment period 1 ]
  • The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done before treatment period 2. ]
  • The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline [ Time Frame: Pharmacodynamic sampling will be done after treatment period 2. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01210339 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2010)
  • The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacokinetics of the active metabolite of clopidogrel by assessing Area Under Curve (AUC) and Cmax.after 9 days of clopidogrel treatment [ Time Frame: Pharmacokinetic sampling will be done at the end of treatment period 1 and 2 (Day 9). ]
  • The safety and tolerability of clopidogrel alone and in combination with esomeprazole/ acetylsalicylic acid [ Time Frame: Safety will be monitored continuously. Adverse events will be collected from the first administration of Investigational Product (IP) throughout the study until the follow-up visit (on average) 7-10 days after last dose. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
  • The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacokinetics of the active metabolite of clopidogrel by assessing AUC and Cmax.after 9 days of clopidogrel treatment [ Time Frame: Pharmacokinetic sampling will be done at the end of treatment period 1 and 2 (Day 9). ]
  • The safety and tolerability of clopidogrel alone and in combination with esomeprazole/ acetylsalicylic acid [ Time Frame: Safety will be monitored continuously. Adverse events will be collected from the first administration of IP throughout the study until the follow-up visit (on average) 7-10 days after last dose. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel
Official Title  ICMJE An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers
Brief Summary The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Clopidogrel
    Clopidogrel
  • Drug: Esomeprazole/ASA
    20 mg/81 mg once daily for five days (Day 5-9)
    Other Name: Axanum
Study Arms  ICMJE
  • Experimental: 1
    Treatment A (Clopidogrel 9 days), at least 14 days wash-out, Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days)
    Interventions:
    • Drug: Clopidogrel
    • Drug: Esomeprazole/ASA
  • Experimental: 2
    Treatment B (Clopidogrel 4 days followed by Clopidogrel + Esomeprazole/ASA 5 days), at least 14 days wash-out, Treatment A (Clopidogrel 9 days)
    Interventions:
    • Drug: Clopidogrel
    • Drug: Esomeprazole/ASA
Publications * Andersson T, Nagy P, Niazi M, Nylander S, Galbraith H, Ranjan S, Wallentin L. Effect of esomeprazole with/without acetylsalicylic acid, omeprazole and lansoprazole on pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers. Am J Cardiovasc Drugs. 2014 Jun;14(3):217-27. doi: 10.1007/s40256-014-0073-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2011)
58
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2010)
59
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
  • Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
  • Have a body mass index between 19 and 30 kg/m2 inclusive
  • No clinically significant abnormal findings at the physical examination as judged by the investigator

Exclusion Criteria:

  • Any clinically significant abnormalities in laboratory screening results as judged by investigator
  • Platelet count <150 x 10^9/L on Day -1 or any other conditions that would increase the risk of bleeding
  • Previous bone marrow transplant
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01210339
Other Study ID Numbers  ICMJE D961FC00010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Peter Nagy, MD AstraZeneca
PRS Account AstraZeneca
Verification Date October 2011

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