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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2006-003674-96
    Sponsor's Protocol Code Number:CV185-036
    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:2010-03-05
    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 number2006-003674-96
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety
    and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill
    Medical Subjects During and Following Hospitalization.

    ADOPT: Apixaban Dosing to Optimize Protection from Thrombosis

    And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date 27-Feb-2007).

    Estudio multicéntrico, fase III, aleatorizado, doble ciego, de brazos paralelos para evaluar la eficacia y seguridad de apixaban para la profilaxis de tromboembolismo venoso en pacientes médicos con enfermedad aguda durante y después de la hospitalización

    ADOPT: tratamiento con apixaban para optimizar la protección contra la trombosis

    Enmienda 01 para estudio farmacogenético en sangre específica de centro, versión 2.0 de fecha 27-Feb-2007
    A.3.2Name or abbreviated title of the trial where available
    ADOPT
    A.4.1Sponsor's protocol code numberCV185-036
    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
    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-562247-01
    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-562247-01 (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 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 Clexane
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameClexane
    D.3.2Product code enoxaparin sodium
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparin sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 mg/0.4ml
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Total Venous thromboembolism (VTE), defined as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein thrombosis (DVT), and asymptomatic proximal DVT.

    Una Enfermedad Tromboembólica Venosa (ETV) total se define como una combinación de embolismo pulmonar mortal y no-mortal, Trombosis Venosa Profunda (TVP) sintomática y TVP proximal asintomática


    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051055
    E.1.2Term Deep vein thrombosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037377
    E.1.2Term Pulmonary embolism
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049918
    E.1.2Term Deep venous thrombosis proximal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to
    standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended
    minimum period of 6 days, in subjects with acute medical illness. Total VTE is defined
    as the combination of fatal or nonfatal pulmonary embolism, symptomatic deep vein
    thrombosis (DVT), and asymptomatic proximal DVT detected by bilateral compression
    ultrasound.
    E.2.2Secondary objectives of the trial
    Efficacy:

    • To demonstrate that oral administration of apixaban 2.5 mg BID is not inferior to
    subcutaneous administration of enoxaparin 40 mg QD for the prevention of total VTE
    and VTE-related death occurring up to the time of discontinuation of parenteral
    therapy.
    • To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total VTE and all cause death compared to subcutaneous administration of enoxaparin 40 mg QD.
    • To assess the effect of orally-administered apixaban 2.5 mg BID on the incidence and time to occurrence of symptomatic PE and symptomatic DVT.
    • To assess the effect of orally-administered apixaban 2.5 mg BID on the rate of
    all-cause mortality at 30 and 90 days after randomization.

    Safety

    • To demonstrate that orally administered apixaban 2.5 mg BID for 30 days is generally safe and well tolerated in this patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must be willing and able to give written informed consent. Consent to participate in the study must be obtained prior to screening.
    2) Subjects hospitalized due to congestive heart failure, acute respiratory failure or with infection (without septic shock), acute rheumatic disorder, or inflammatory bowel
    disease.
    3) Except for subjects with congestive heart failure or respiratory failure, subjects must have one additional factor including:
    a) age ≥ 75
    b) previous documented VTE or history of VTE for which they received anticoagulation for at least 6 weeks
    c) cancer
    d) BMI ≥ 30 (See Appendix 4 for BMI chart)
    e) estrogenic hormone therapy
    f) chronic heart or respiratory failure
    4) Expected hospitalization of ≥ 3 days after randomization
    5) Severely or moderately restricted mobility (i.e. bedridden or limited to chair, walking to bathroom or within room; see section 6.9.1)
    6) Men and women, of any race, at least 40 years of age

    Women of childbearing potential (WOCBP) must be using an adequate method of
    contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
    E.4Principal exclusion criteria
    1) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study period
    2) WOCBP using a prohibited contraceptive method
    3) Women who are pregnant or breastfeeding
    4) Women with a positive pregnancy test on enrollment or prior to investigational
    product administration
    5) Subjects with a confirmed VTE
    6) Subjects with diseases requiring ongoing treatment with a parenteral or oral
    anticoagulant, e.g. subjects with mechanical valves, warfarin eligible atrial fibrillation
    7) Subjects with conditions requiring treatment with parenteral or oral antiplatelet agents other than aspirin ≤ 165 mg/day
    8) Active liver disease as evidenced by abnormal laboratory test findings (see physical and laboratory findings below)
    9) Anemia or thrombocytopenia as evidenced by abnormal laboratory test findings (see physical and laboratory findings below)
    10) Severe renal disease as evidenced by creatinine clearance < 30 mL/min as estimated by the method of Cockcroft and Gault (see Section 6.3.1.2)
    11) Subjects hospitalized more than 48 hours prior to randomization
    12) Subjects who are unable to take oral medications
    13) Subjects who have had surgery in the past 30 days that may be associated with a risk of bleeding
    14) Subjects who have received anticoagulant prophylaxis for VTE in the past 14 days consisting of more than two doses of enoxaparin or another low molecular weight heparin, more than four doses of unfractionated heparin, or more than two doses of an oral anticoagulant
    15) Subjects with active bleeding or high risk of bleeding
    16) Subjects with planned or scheduled invasive procedures during the treatment period
    17) Subjects in whom in the opinion of the Investigator it is not possible to obtain an
    adequate bilateral compression ultrasound evaluation
    18) Subjects with acute shock
    19) Subjects with a life expectancy < 1 month
    20) Abnormal hematological findings:
    • Hemoglobin < 10 g/dL
    • Platelet count < 100,000/mm
    21) Abnormal liver function tests:
    • ALT or AST > 2 X ULN or
    • bilirubin (direct or total) > 1.5 X ULN (unless in an alternative causative factor
    [e.g., Gilbert’s syndrome] is identified)
    22) Known or suspected allergies to enoxaparin or prior heparin-induced
    thrombocytopenia
    23) Use of bevacizumab (Avastin®) therapy within the previous 6 months or planned use during the study period
    24) Presently receiving oral anticoagulant therapy
    25) Presently receiving oral antiplatelet therapy other than aspirin at a dose ≤ 165 mg.
    26) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study
    27) Administration of any investigational drug currently or within 30 days prior to
    planned enrollment into this study
    28) Subjects unwilling or unable to comply with study medication instructions including the use of enoxaparin or matching placebo for the recommended minimum treatment duration of 6 days
    29) Subjects unwilling or unable to comply with study procedures (e.g., bilateral
    compression ultrasound) specified in the protocol
    30) Subjects who have previously been randomized in an experimental study of apixaban
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome measure is a composite endpoint of adjudicated total VTE and VTE-related death during 30 days of double-blind treatment, in acutely ill medical subjects during and following hospitalization.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 state281
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2793
    F.4.2.2In the whole clinical trial 7502
    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 Decision2007-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-18
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