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

Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01129388
First received: May 21, 2010
Last updated: December 14, 2011
Last verified: December 2011

May 21, 2010
December 14, 2011
March 2009
May 2009   (final data collection date for primary outcome measure)
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5µM after 5 days treatment [ Time Frame: Day 5 of each period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01129388 on ClinicalTrials.gov Archive Site
  • Maximum platelet aggregation intensity (MAI) induced by ADP 20µM after 5 days treatment [ Time Frame: Day 5 of each period ] [ Designated as safety issue: No ]
  • Platelet Reactivity Index - Vasodilatator-stimulated phosphoprotein test (PRI - VASP) after 5 days treatment [ Time Frame: Day 5 of each period ] [ Designated as safety issue: No ]
  • Clopidogrel pharmacokinetic parameters (maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC0-24)) after 5 days treatment [ Time Frame: Up to 24 hours postdose on Day 5 for each period ] [ Designated as safety issue: No ]
  • Clopidogrel active metabolite pharmacokinetic parameters (Cmax and AUC0-24) after 5 days treatment [ Time Frame: Up to 24 hours postdose on Day 5 for each period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects
A Randomized, Placebo-controlled, Two-period, Two-treatment, Two Sequence, Cross-over Pharmacodynamic and Pharmacokinetic Interaction Study After 5-days Repeated Oral Doses of Clopidogrel (300 mg Loading Dose Followed by 75 mg/Day) Alone or Given With Omeprazole 80 mg/Day (12 Hours Apart on the Same Days) in Healthy Male and Female Subjects

Primary objective:

  • Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects

Secondary Objectives:

  • Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval

The total study duration per subjects is 8-9 weeks broken down as follows:

  • Screening: 2 to 21 days before the first dosing
  • Period clopidogrel/placebo: 7 days including 5 days treatment
  • Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
  • Washout between periods: at least 14 days period after last dosing respect to clopidogrel treatment
  • End of study: at 7 to 10 days after the last dosing
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: clopidogrel

    Pharmaceutical form: tablet

    Route of administration: oral

    Other Name: SR25990
  • Drug: Placebo

    Pharmaceutical form: matching tablet

    Route of administration: oral

  • Drug: omeprazole

    Pharmaceutical form: delayed-release capsule

    Route of administration:oral

  • Experimental: Group clopidogrel - clopidogrel + omeprazole

    Period 1:

    • Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions
    • Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily

    Period 2:

    • Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily
    • Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
    • Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily
    Interventions:
    • Drug: clopidogrel
    • Drug: omeprazole
  • Placebo Comparator: Group placebo - placebo + omeprazole

    Period 1:

    • Day 1: placebo loading dose in the morning under fasted conditions
    • Day 2 to Day 5: placebo in the morning under fasted conditions, once daily

    Period 2:

    • Day -5 to Day -1: omeprazole 80 mg in the evening 2 hours after dinner, once daily
    • Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
    • Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily
    Interventions:
    • Drug: Placebo
    • Drug: omeprazole
  • Experimental: Group clopidogrel + omeprazole - clopidogrel

    Period 1:

    • Day -5 to Day -1: omeprazole 80 mgin the evening 2 hours after dinner, once daily
    • Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
    • Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily

    Period 2:

    • Day 1: clopidogrel 300 mg loading dose in the morning under fasted conditions
    • Day 2 to Day 5: clopidogrel 75 mg in the morning under fasted conditions, once daily
    Interventions:
    • Drug: clopidogrel
    • Drug: omeprazole
  • Placebo Comparator: Group placebo + omeprazole placebo

    Period 1:

    • Day -5 to Day -1: omeprazole 80 mg, once daily in the evening 2 hours after dinner
    • Day 1: placebo loading dose in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner
    • Day 2 to Day 5: placebo in the morning under fasted conditions + omeprazole 80 mg in the evening 2 hours after dinner, once daily

    Period 2:

    • Day 1: placebo loading dose in the morning under fasted conditions
    • Day 2 to Day 5: placebo in the morning under fasted conditions, once daily
    Interventions:
    • Drug: Placebo
    • Drug: omeprazole
Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther. 2011 Jan;89(1):65-74. Epub 2010 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy subject,

  • as determined by medical history, physical examination including vital signs and clinical laboratory tests.
  • with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²

Exclusion Criteria:

  • Evidence of inherited disorder of coagulation/hemostasis functions
  • Smoking more than 5 cigarettes or equivalent per day
  • Abnormal hemostasis screen
  • Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
  • Any contraindication to clopidogrel and/or omeprazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01129388
INT11166
No
Sanofi
Sanofi
Bristol-Myers Squibb
Study Director: International Clinical Development Study Director Sanofi
Sanofi
December 2011

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