Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01147588
First received: June 4, 2010
Last updated: June 27, 2011
Last verified: June 2011

June 4, 2010
June 27, 2011
May 2010
May 2011   (final data collection date for primary outcome measure)
  • Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). [ Time Frame: Day 2 ] [ Designated as safety issue: Yes ]
  • Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
  • Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). [ Time Frame: Day 15 ] [ Designated as safety issue: Yes ]
  • Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA). [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01147588 on ClinicalTrials.gov Archive Site
  • Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the AUC, AUC 0-t and Cmax after the loading dose of clopidogrel (Day 1) and AUC 0-t, ss and Css, max. [ Time Frame: Days 5,14, 29 ] [ Designated as safety issue: Yes ]
  • Evaluate the safety and tolerability of clopidogrel given concomittantly with esomeprazole, omeprazole or lansoprazole by assessment of adverse events and calculation of change from baseline for clinical laboratory tests, vital signs and pECG. [ Time Frame: Every in-house day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel
An Open-label, Randomized, 4-treatment, 3-period, Crossover Interaction Study, Evaluating the Effect of Esomeprazole 40 mg, Omeprazole 80 mg or Lansoprazole 60 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel in Healthy Volunteers

The aim of this study is to determine if there is a pharmacological interaction between clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this possible interaction would change over time.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: lansoprazole
    60 mg (2x30-mg capsule), once daily
  • Drug: omeprazole
    80 mg (2x40-mg capsule), once daily
  • Drug: esomeprazole
    40 mg (1x40-mg capsule), once daily
  • Drug: clopidogrel
    300 mg loading dose on Day 1 then 75 mg daily for 28 days
  • Experimental: 1
    lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg
    Interventions:
    • Drug: lansoprazole
    • Drug: clopidogrel
  • Experimental: 2
    omeprazole 80 mg + clopidogrel 300/75 mg
    Interventions:
    • Drug: omeprazole
    • Drug: clopidogrel
  • Experimental: 3
    esomeprazole 40 mg + clopidogrel 300/75 mg
    Interventions:
    • Drug: esomeprazole
    • Drug: clopidogrel
  • Experimental: 4
    clopidogrel 300/75 mg alone
    Intervention: Drug: clopidogrel
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.
 
Completed
149
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males within the age of 18-45 years and females within the age of 18-55 years with suitable veins for cannulation or repeated vein puncture. Females must be of non-childbearing potential.
  • Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
  • No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in study.
  • History or presence of gastrointestinal e.g. 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. Any medical/surgical procedure or trauma within 3 months of the treatment period; scheduled surgery, including dental surgery within 2 weeks.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01147588
D9612C00034
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Kelli Craven, MD Quintiles
Study Director: Ken Price AstraZeneca
Study Chair: Mirjana Kujacic AstraZeneca
AstraZeneca
June 2011

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