Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36348   clinical trials with a EudraCT protocol, of which   5989   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004708-30
    Sponsor's Protocol Code Number:DU176b-D-U311
    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:2015-04-27
    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 number2014-004708-30
    A.3Full title of the trial
    A PHASE 3B, PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLIND EVALUATOR (PROBE) STUDY EVALUATING THE EFFICACY AND
    SAFETY OF (LMW) HEPARIN/EDOXABAN VERSUS DALTEPARIN IN VENOUS THROMBOEMBOLISM ASSOCIATED WITH CANCER
    ESTUDIO DE FASE IIIB, PROSPECTIVO, ABIERTO, CON ENMASCARAMIENTO
    DE LOS EVALUADORES (PROBE) EN EL QUE SE EVALÚAN LA EFICACIA Y LA
    SEGURIDAD DE HEPARINA (BPM)/EDOXABÁN EN COMPARACIÓN CON
    DALTEPARINA PARA EL TROMBOEMBOLISMO VENOSO ASOCIADO AL
    CÁNCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Edoxaban/heparin versus dalteprin in cancer patients for prevention of thrombosis
    Edoxabán para el tromboembolismo venoso asociado al cáncer (TEV cáncer
    Hokusai)
    A.4.1Sponsor's protocol code numberDU176b-D-U311
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02073682
    A.5.4Other Identifiers
    Name:IND numberNumber:63,266
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDaiichi Sankyo Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportDaiichi Sankyo Development Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportDaiichi Sankyo Pharma Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.6E-maileuregaffairs@dsd-eu.com
    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 nameedoxaban
    D.3.2Product code DU-176b
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNedoxaban
    D.3.9.1CAS number 480449-71-6
    D.3.9.2Current sponsor codeDU-176b
    D.3.9.3Other descriptive nameEDOXABAN TOSYLATE
    D.3.9.4EV Substance CodeSUB35059
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.2.1.1.1Trade name The choice of the parenteral LMWH in the current protocol is defined by the treating physician that is availabe in the country. The ATC for these agents is B01AB
    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 namelow molecular weight heparin
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 9041-08-1
    D.3.9.3Other descriptive nameClexane
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Fragmin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDalteparin
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 INNdalteparin sodium
    D.3.9.3Other descriptive nameDALTEPARIN SODIUM
    D.3.9.4EV Substance CodeSUB11889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5000 to 18000
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    venous thromboembolism associated with cancer
    Tromboembolismo venoso asociado al cáncer
    E.1.1.1Medical condition in easily understood language
    blood clot associated with cancer
    coágulo de sangre asociado a cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10066899
    E.1.2Term Venous thromboembolism
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the non-inferiority of a 12-month course of low molecular weight heparin (LMWH)/edoxaban compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer. If non-inferiority is established, edoxaban will be compared with dalteparin for superiority.
    El objetivo principal es demostrar la no inferioridad de un ciclo de 12
    meses de heparina de bajo peso molecular (HBPM)/edoxabán en
    comparación con dalteparina para la prevención del resultado combinado
    del tromboembolismo venoso (TEV) recurrente o hemorragia grave en
    sujetos con TEV asociado al cáncer. Si se establece la no inferioridad,
    edoxabán se comparará con dalteparina para determinar la superioridad.
    E.2.2Secondary objectives of the trial
    To compare LMWH/edoxaban with dalteparin with regards to rates of:
    1. Recurrent VTE;
    2. Major bleeding;
    3. Clinically relevant non-major (CRNM) bleeding;
    4. Major + CRNM bleeding;
    5. Event-free survival, defined as the proportion of subjects over time free of recurrent VTE, major bleeding events, and death;
    6. VTE-related death;
    7. Mortality from all causes;
    8. Recurrent deep vein thrombosis (DVT);
    9. Recurrent pulmonary embolism (PE);
    10. Healthcare resource utilization for potential recurrent VTE and bleed events.
    comparar HBPM/edoxabán con dalteparina con respecto a las tasas de:
    1.TEV recurrente
    2.Hemorragias graves
    3.Hemorragias graves y no graves clínicamente relevantes (NGCR)
    4.Hemorragia grave + NGCR
    5.Supervivencia libre de acontecimientos, definida como la proporción de
    sujetos conforme pasa el tiempo sin TEV recurrente, episodios de
    hemorragia importantes ni muerte
    6.Muerte relacionada con el TEV
    7.Mortalidad por todas las causas
    8.Trombosis venosa profunda recurrente (TVP)
    9.Embolismo pulmonar (EP) recurrente
    10.Utilización de recursos sanitarios para posibles acontecimientos de
    hemorragia y TEV recurrente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult subjects presenting with VTE associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin) for whom long-term treatment with LMWH is intended are eligible to participate in the study.
    Subjects must satisfy all of the following criteria to be included in the study:
    1. Male or female subjects with age ? 18 years or the otherwise legal lower age according to the country of residence;
    2. Confirmed symptomatic or unsuspected lower extremity proximal DVT (ie, popliteal, femoral, iliac or inferior vena cava (IVC) vein thrombosis), or confirmed symptomatic PE, or unsuspected PE of a segmental or larger pulmonary artery;
    3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to randomization. [Note: Diagnosis of cancer must be objectively documented];
    4. Intention for long-term treatment (at least 6 months) with parenteral LMWH;
    5. Able to provide written informed consent.
    Podrán participar en el estudio los sujetos adultos, que presenten TEV
    asociado al cáncer (excepto el carcinoma cutáneo de células basales o
    escamosas) para quienes esté indicado el tratamiento a largo plazo con
    HBPM.
    Entre los criterios de elegibilidad clave se incluyen:
    Criterios de inclusión:
    1.Hombres o mujeres ? 18 años de edad o la edad que se considere
    legalmente adulta según el país de residencia
    2.TVP sintomática o insospechada, confirmada, proximal en las
    extremidades inferiores (es decir, trombosis de la vena popliteal, la vena
    femoral, la vena ilíaca o la vena cava inferior) o EP sintomática
    confirmada o EP insospechada de una arteria pulmonar segmental o
    mayor
    3.Cáncer, excepto el carcinoma cutáneo de células basales o escamosas.
    El cáncer debe estar activo o se debe haber diagnosticado en un plazo de 2 años previos a la aleatorización. El diagnóstico/los antecedentes de cáncer deben estar documentados de
    manera objetiva
    4.Intención de recibir tratamiento a largo plazo (al menos 6 meses) con HBPM parenteral
    5.Capaces de otorgar su consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
    2. More than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment (LMWH, unfractionated heparin, and fondaparinux per local labeling), oral direct anticoagulants or VKA prior to randomization to treat the current (index) episode;
    3. Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
    4. Active bleeding or any contraindication for treatment with LMWH/dalteparin or edoxaban;
    5. Indication for dalteparin other than DVT and/or PE;
    6. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or 4 at the time of randomization (Appendix 17.6);
    7. Calculated CrCL < 30 mL/min;
    8. History of heparin associated thrombocytopenia;
    9. Acute hepatitis, chronic active hepatitis, liver cirrhosis;
    10. Hepatocelullar injury with concurrent transaminase (ALT/AST > 3 x ULN) and bilirubin (> 2 x ULN) elevations in the absence of a clinical explanation;
    11. Life expectancy < 3 months;
    12. Platelet count < 50,000/mL;
    13. Uncontrolled hypertension as judged by the Investigator (eg, systolic blood pressure (BP) > 170 mmHg or diastolic blood pressure > 100 mmHg despite antihypertensive treatment);
    14. Women of childbearing potential without proper contraceptive measures, and women who are pregnant or breast feeding;
    Note: Childbearing potential without proper contraceptive measures (ie, a method of contraception with a failure rate < 1 % during the course of the study including the observational period). These methods of contraception according to the note for guidance on nonclinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence, and vasectomy for the male partner).
    15. Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2
    (COX-2) inhibitors for ? 4 days/week anticipated to continue during the study;
    16. Treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy (any 2 antiplatelet agents including aspirin plus any other oral or intravenous [IV] antiplatelet drug) anticipated to continue during the study;
    17. Treatment with the P-gp inhibitors ritonavir, nelfinavir, indinavir, or saquinavir anticipated to continue during the study;
    18. Systemic use of the P-gp inhibitors ketoconazole, itraconazole, erythromycin, azithromycin or clarithromycin at the time of randomization; subsequent use is permitted;
    19. Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
    1. Trombectomía, inserción de un filtro caval, o uso de un agente
    fibrinolítico para tratar el episodio actual (de referencia) de TVP y/o EP
    2. Más de 72 horas de tratamiento previo con anticoagulantes (HBPM,
    heparina no fraccionada y fondaparinux según la etiqueta local),
    anticoagulantes orales directos o agonistas de la vitamina K (AVK) antes
    de la aleatorización para tratar el episodio actual (de referencia)
    3.Tratamiento con dosis terapéuticas de un anticoagulante excepto el
    que se usa para el tratamiento previo del episodio actual de TEV (de
    referencia) antes de la aleatorización
    4. Hemorragia activa o cualquier contraindicación para el tratamiento
    con HBPM/dalteparina o edoxabán
    5. Indicación para dalteparina distinta de TVP y/o EP
    6. Un estado general de 3 o 4 según la Escala del Grupo Oncológico
    Cooperativo del Este (ECOG) en el momento de la aleatorizaciónApéndice
    17.6)
    7. Aclaramiento calculado de la creatinina (ACr) < 30 ml/min
    8. Antecedentes de heparina asociada a trombocitopenia
    9. Hepatitis aguda, hepatitis activa crónica, cirrosis hepática
    10. Lesión hepatocelular con elevaciones concurrentes de las
    transaminasas (alanina transaminasa [ALT]/aspartato transaminasa
    [AST] > 3 veces el límite superior de la normalidad [LSN]) y bilirrubina
    (> 2 veces el LSN) a falta de una explicación clínica
    11. Esperanza de vida < 3 meses
    12. Recuento de plaquetas < 50.000/ml
    13. Hipertensión descontrolada a criterio del investigador (p. ej., presión
    arterial sistólica > 170 mmHg o presión arterial diastólica > 100 mmHg a
    pesar del tratamiento antihipertensivo)
    14. Mujeres en edad fértil sin medidas anticonceptivas adecuadas y
    mujeres que estén embarazadas o en período de lactancia
    15. El tratamiento crónico con fármacos antiinflamatorios no esteroideos
    (AINE) excepto la aspirina, incluidos los inhibidores de la
    ciclooxigenasa-1 (COX-1) y la ciclooxigenasa-2 (COX-2) durante ? 4
    días/semana, que se prevea que continúe durante el estudio
    16. Tratamiento con aspirina con dosis de más de 100 mg/al día o
    tratamiento antiplaquetario doble (2 agentes antiplaquetarios
    cualesquiera, entre los que se incluyen la aspirina más cualquier otro
    fármaco antiplaquetario oral o intravenoso) que se prevea que continúe
    durante el estudio
    17. Tratamiento con los inhibidores de la gp-P ritonavir, nelfinavir,
    indinavir o saquinavir. que se prevea que continúe durante el estudio
    18. Uso sistémico de los inhibidores de la gp-P ketoconazol, itraconazol,
    eritromicina, azitromicina o claritromicina en el momento de la
    aleatorización; su uso posterior está permitido
    19. Sujetos con cualquier afección que, a criterio del Investigador,
    implicaría para el sujeto un aumento del riesgo de perjuicio si
    participase en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary study outcome is the composite of recurrent
    VTE, and major bleeding.
    Recurrent VTE is either:
    -symptomatic confirmed (new) DVT or (new) PE;
    -unsuspected (new) proximal DVT of the legs or unsuspected (new) PE located in segmental or more proximal arteries:
    Unsuspected DVT or PE are thrombi that are detected during imaging testing performed for other reasons (eg, computed tomography (CT) for cancer staging) and not for suspicion of DVT or PE.
    -fatal PE (including unexplained death for which PE cannot be ruled out).
    El resultado principal del estudio es la combinación de TEV recurrente y
    hemorragia grave.
    El TEV recurrente es:
    - TVP (nueva) sintomática confirmada o EP (nueva)
    - TVP proximal (nueva) insospechada de las piernas o EP (nueva)
    insospechada localizada en las arterias segmentales o en las arterias
    más proximales:
    El TVP o la EP insospechados son trombos que se detectan durante las
    pruebas de imagen realizadas por otras razones (p. ej., tomografía axial
    computarizada [TAC] para determinar el estadio del cáncer) y no en el
    caso de sospecha de TVP o EP.
    - EP mortal (incluido el fallecimiento sin explicación en el que no se
    pueda excluir la EP como causa)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    E.5.2Secondary end point(s)
    -Recurrent VTE;
    -Major bleeding;
    -CRNM bleeding;
    -Major + CRNM bleeding;
    -Event-free survival, defined as the proportion of subjects over time free of recurrent VTE, major bleeding events, and death;
    -VTE-related death;
    -Mortality from all causes;
    -Recurrent DVT;
    -Recurrent PE;
    -Healthcare resource utilization for potential
    recurrent VTE and bleed events.
    -TEV recurrente
    - Hemorragias graves
    - Hemorragia NGCR
    - Hemorragia grave + NGCR
    - Supervivencia libre de acontecimientos, definida como la proporción de
    sujetos conforme pasa el tiempo sin TEV recurrente, episodios de
    hemorragia importantes ni muerte
    - Muerte relacionada con el TEV
    - Mortalidad por todas las causas
    - TVP recurrente
    - EP recurrente
    - Utilización de recursos sanitarios para posibles acontecimientos de
    hemorragia y TEV recurrente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Evaluador ciego (Probe)
    Blind evaluator (probe)
    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.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Netherlands
    New Zealand
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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
    Once 1000 subjects are randomized, a global End-of-Treatment (EOT) date will be established that ensures a minimum of 6 months of study treatment and follow-up for the final subject(s) randomized. All subjects will permanently discontinue study treatment on or before the EOT date.
    Una vez se haya aleatorizado a 1000 sujetos en el estudio, se
    establecerá una fecha de fin de tratamiento (FdT) general que
    garantizará un mínimo de 6 meses de tratamiento del estudio y
    seguimiento para el/los último(s) sujeto(s) aleatorizado(s). Todos los
    sujetos interrumpirán de forma permanente el tratamiento del estudio
    en la fecha de FdT o con anterioridad a esta.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 620
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 614
    F.4.2.2In the whole clinical trial 1000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    ninguno
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA