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Trial record 86 of 360 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01409616
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : March 21, 2013
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE August 1, 2011
First Posted Date  ICMJE August 4, 2011
Last Update Posted Date March 21, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2011)
Assessment of pharmacodynamics of darexaban [ Time Frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2011)
  • Assessment of pharmacodynamics of ASA and a combination of ASA and clopidogrel [ Time Frame: Baseline and up to 24 hours after six days of dosing of darexaban, ASA, clopidogrel, or a combination ]
  • Pharmacokinetics of ASA and the combination of ASA and clopidogrel assessed by plasma concentration [ Time Frame: Plasma samples are taken until 24 hours after six days of dosing of ASA, a combination of ASA and clopidogrel, or the combination with darexaban ]
  • Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events [ Time Frame: 6 days for each of the 2 treatment periods ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Whether Acetyl Salicylic Acid (Aspirin), the Combination of Aspirin and Clopidogrel and Darexaban (YM150) Interact in Their Effects
Official Title  ICMJE A Randomized, Open-label, Two-period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Effect of Darexaban (YM150) on Acetyl Salicylic Acid (ASA) and of Darexaban on the Combination of ASA and Clopidogrel at Steady State
Brief Summary The primary objective of this study is to evaluate whether ASA, the combination of ASA and clopidogrel, and darexaban, which have different effects on blood coagulation, influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.
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)
Condition  ICMJE
  • Pharmacodynamic Interaction
  • Healthy Subjects
Intervention  ICMJE
  • Drug: darexaban
    oral
    Other Name: YM150
  • Drug: darexaban (double dose)
    oral
    Other Name: YM150
  • Drug: Acetyl Salicylic Acid
    oral
    Other Name: Aspirin
  • Drug: clopidogrel
    oral
    Other Name: Plavix
Study Arms  ICMJE
  • Experimental: Treatment arm A
    ASA, wash-out (w.o.), ASA + darexaban
    Interventions:
    • Drug: darexaban
    • Drug: Acetyl Salicylic Acid
  • Experimental: Treatment arm B
    ASA + darexaban, w.o., ASA
    Interventions:
    • Drug: darexaban
    • Drug: Acetyl Salicylic Acid
  • Experimental: Treatment arm C
    ASA, w.o., darexaban (double dose) + ASA
    Interventions:
    • Drug: darexaban (double dose)
    • Drug: Acetyl Salicylic Acid
  • Experimental: Treatment arm D
    darexaban (double dose) + ASA, w.o., ASA
    Interventions:
    • Drug: darexaban (double dose)
    • Drug: Acetyl Salicylic Acid
  • Experimental: Treatment arm E
    ASA + clopidogrel, w.o., ASA + clopidogrel + darexaban
    Interventions:
    • Drug: darexaban
    • Drug: Acetyl Salicylic Acid
    • Drug: clopidogrel
  • Experimental: Treatment arm F
    ASA + clopidogrel + darexaban, w.o., ASA + clopidogrel
    Interventions:
    • Drug: darexaban
    • Drug: Acetyl Salicylic Acid
    • Drug: clopidogrel
  • Experimental: Treatment arm G
    ASA + clopidogrel, w.o., darexaban (double dose) + ASA + clopidogrel
    Interventions:
    • Drug: darexaban (double dose)
    • Drug: Acetyl Salicylic Acid
    • Drug: clopidogrel
  • Experimental: Treatment arm H
    darexaban (double dose) + ASA + clopidogrel, w.o., ASA + clopidogrel
    Interventions:
    • Drug: darexaban (double dose)
    • Drug: Acetyl Salicylic Acid
    • Drug: clopidogrel
Publications * Not Provided

*   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: August 3, 2011)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) between 18.5-30.0 kg/m2
  • Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

  • Known or suspected hypersensitivity to darexaban or ASA or any components of the formulation used
  • Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
  • Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
  • Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
  • Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
  • Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit.
  • Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
  • Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study
  • Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01409616
Other Study ID Numbers  ICMJE 150-CL-035
2007-007036-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Principal Investigator: Principal Investigator SGS Aster, Paris, France
PRS Account Astellas Pharma Inc
Verification Date August 2011

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