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    The EU Clinical Trials Register currently displays   42314   clinical trials with a EudraCT protocol, of which   6969   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002147-91
    Sponsor's Protocol Code Number:CV185-030
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-04-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2006-002147-91
    A.3Full title of the trial
    "Estudio BMS CV185030- Estudio fase III, controlado con Warfarina, aleatorizado, doble ciego y de brazos paralelos, para evaluar la seguridad y la eficacia de Apixaban en la prevención de accidente cerebrovascular y embolismo sistémico en pacientes con fibrilación auricular no valvular."

    A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation

    + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific, version 3.0, dated 04-Nov-2006
    A.3.2Name or abbreviated title of the trial where available
    ARISTOTLE
    A.4.1Sponsor's protocol code numberCV185-030
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApixaban
    D.3.2Product code BMS-562247
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApixaban
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codeBMS-562247 (laboratory code)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApixaban
    D.3.2Product code BMS-562247
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApixaban
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codeBMS-562247 (laboratory code)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Coumadin
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Company
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCoumadin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWarfarin sodium
    D.3.9.1CAS number 129-06-6
    D.3.9.2Current sponsor codeBMS 565793
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ARRITMIA; TROMBOSIS

    ARRHYTHMIA; THROMBOSIS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057613
    E.1.2Term Thromboembolic stroke
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the
    combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in
    subjects with AF and at least one additional risk factor for stroke.
    E.2.2Secondary objectives of the trial
    • Determine in subjects with AF & at least 1 additional risk factor for stroke,
    whether apixaban is superior to warfarin in combined endpoints of:
    - ischemic stroke, hemorrhagic stroke & systemic embolism
    − ischemic stroke, hemorrhagic stroke, systemic embolism & major bleeding, in warfarin naïve subjects
    − ischemic stroke, hemorrhagic stroke, systemic embolism and major bleeding
    • To compare, in subjects with AF & at least 1 additional risk factor for stroke,
    apixaban and warfarin with respect to the composite endpoint of:
    - ischemic stroke, hemorrhagic stroke, systemic embolism & all cause death
    − ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding & all cause death
    − ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction & all cause death
    − incidence of major bleeding
    • To assess safety of apixaban in subjects with AF & at least 1 additional risk
    factor for stroke.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For entry into the study, the following criteria MUST be met.
    1) Age >= 18 years
    2) Permanent or persistent atrial fibrillation or atrial flutter documented by ECG at the
    time of enrollment.
    OR
    If not in atrial fibrillation/flutter at the time of enrollment, must have atrial
    fibrillation/flutter documented on two separate occasions at least 2 weeks apart in the 6
    months prior to enrollment. Atrial fibrillation/flutter may be documented by ECG, or as
    an episode at least one minute in duration on a rhythm strip or Holter recording.
    3) One or more of the following risk factor(s) for stroke:
    a) Age 75 years or older
    b) Prior stroke, TIA or systemic embolus
    c) Either symptomatic congestive heart failure within 3 months or left ventricular
    dysfunction with an LV ejection fraction (LVEF) =< 40% by echocardiography,
    radionuclide study or contrast angiography
    d) Diabetes mellitus
    e) Hypertension requiring pharmacological treatment
    4) Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the treatment period of the study or for
    2 weeks after the last dose of study medication, whichever is longer, in such a manner that the risk of pregnancy is minimized.
    WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral
    contraceptives, other hormonal contraceptives (vaginal products, skin patches, or
    implanted or injectable products), or mechanical products such as an intrauterine device
    or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or arepracticing abstinence or where their partner is sterile (eg, vasectomy) should be
    considered to be of childbearing potential.
    WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25
    IU/L or equivalent units of HCG) within 48 hours prior to the start of investigational
    product.
    5) All subjects must provide signed written informed consent.
    E.4Principal exclusion criteria
    1) Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
    2) Clinically significant (moderate or severe) mitral stenosis
    3) Increased bleeding risk that is believed to be a contraindication to oral anticoagulation
    (e.g. documented peptic ulcer disease within 6 months, previous intracranial
    hemorrhage)
    4) Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.
    prosthetic mechanical heart valve)
    5) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg, or diastolic BP
    > 100 mm Hg)
    6) Active infective endocarditis
    7) Planned major surgery
    8) Planned atrial fibrillation or flutter ablation procedure
    9) Use of an unapproved, investigational drug or device within the past 30 days
    10) Required treatment with aspirin > 165 mg/day
    11) Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel,
    ticlopidine)
    12) Severe comorbid condition with life expectancy of =< 1 year
    13) Active alcohol or drug abuse, or psychosocial reasons that make study participation
    impractical
    14) Recent stroke (within 30 days)
    15) Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine
    clearance < 25 mL/min)
    16) ALT or AST > 2X ULN or a Total Bilirubin >= 1.5X ULN (unless an alternative
    causative factor [e.g., Gilbert’s syndrome] is identified)
    17) Platelet count =< 100,000/ mm3
    18) Hemoglobin < 10 g/dL
    19) Inability to comply with INR monitoring
    20) Prior randomization into an apixaban clinical study
    21) Prisoners or subjects who are involuntarily incarcerated
    22) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (e.g., infectious disease) illness
    23) Women of child bearing potential (WOCBP) unwilling or unable to use an acceptable
    method to avoid pregnancy:
    a) WOCBP using a prohibited contraceptive method
    b) WOCBP include any female who has experienced menarche and who has not
    undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
    or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >= 12
    consecutive months; or women on hormone replacement therapy (HRT) with
    documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL]. Even
    women who are using oral contraceptives, other hormonal contraceptives (vaginal
    products, skin patches, or implanted or injectable products), or mechanical
    products such as an intrauterine device or barrier methods (diaphragm, condoms,
    spermicides) to prevent pregnancy, or are practicing abstinence or where their
    partner is sterile (e.g., vasectomy) should be considered to be of child bearing
    potential
    c) Women who are pregnant or breastfeeding
    d) Women with a positive pregnancy test on enrollment or prior to administration of
    investigational product.
    Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and the integrity of the study data. It is imperative that subjects fully meet all eligibility criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    The primary efficacy endpoint will be the time to first occurrence of confirmed ischemic stroke, hemorrhagic or systemic embolism.

    The secondary efficacy endpoints will be time to first occurrence of confirmed:
    • ischemic stroke
    • hemorrhagic stroke
    • systemic embolism
    • all cause death
    • composite of ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding
    • composite of ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death
    • composite of ischemic stroke, hemorrhagic stroke, systemic embolism, major bleeding, all cause death
    • composite of ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction, all cause death

    Primary safety endpoint
    The primary safety endpoint is the time to first occurrence of confirmed major bleeding.

    Secondary safety endpoints
    The secondary safety outcome for this trial is a composite of confirmed major bleeding and confirmed clinically significant non-major bleeding. Other safety outcome measures will also be assessed, and will include minor bleeds, fractures and other AEs as well as abnormal standard clinical laboratory test results.
    All major bleeding and clinically relevant non-major bleeding outcomes will be adjudicated by CEC.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA165
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state516
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5010
    F.4.2.2In the whole clinical trial 15000
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-25
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