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    Summary
    EudraCT Number:2013-000046-19
    Sponsor's Protocol Code Number:RIVAROXHFA3001/BAY59-7939/16302
    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:2013-06-25
    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 number2013-000046-19
    A.3Full title of the trial
    A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Oral Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Chronic Heart Failure and Significant Coronary Artery Disease Following a Hospitalization for Exacerbation of Heart Failure
    Estudio multicéntrico, aleatorizado, doble ciego, basado en eventos, que compara la eficacia y seguridad de Rivaroxaban oral con placebo en la reducción del riesgo de muerte, infarto de miocardio o ictus, en pacientes con insuficiencia cardiaca crónica y enfermedad arterial coronaria significativa tras una hospitalización por exacerbación de la insuficiencia cardiaca.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Rivaroxaban in patients with heart failure when they are hospitalized for worsening of their heart failure
    Estudio de Rivaroxaban en pacientes con insuficiencia cardiaca cuando son hospitalizados por exacerbación de la insuficiencia cardiaca.
    A.3.2Name or abbreviated title of the trial where available
    COMMANDER HF Study
    Estudio COMMANDER HF
    A.4.1Sponsor's protocol code numberRIVAROXHFA3001/BAY59-7939/16302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/134/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development
    B.5.2Functional name of contact pointWilliam Byra, MD
    B.5.3 Address:
    B.5.3.1Street Address920 Route 202 South
    B.5.3.2Town/ cityRaritan, NJ
    B.5.3.3Post code08869
    B.5.3.4CountryUnited States
    B.5.4Telephone number011908927 3540
    B.5.6E-mailwbyra@its.jnj.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 Yes
    D.2.1.1.1Trade name Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRivaroxaban
    D.3.2Product code JNJ-39039039/BAY 59-7939
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY 59-7939
    D.3.9.4EV Substance CodeSUB29263
    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) 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of death, heart attack and stroke in patients with chronic heart failure and significant coronary artery disease following a hospitalization for exacerbation of heart failure.
    Reducción del riesgo de muerte, infarto de miocardio o ictus en pacientes con insuficiencia cardiaca crónica y enfermedad arterial coronaria significativa tras una hospitalización por exacerbación de la insuficiencia cardiaca
    E.1.1.1Medical condition in easily understood language
    Patients with heart failure following hospitalization for worsening of their heart failure
    Pacientes con insuficiencia cardiaca seguida de hospitalización por exacerbación de la insuficiencia cardiaca.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    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 that rivaroxaban is superior to placebo in subjects with chronic heart failure and significant coronary artery disease , who are receiving standard care, in reducing the risk of the composite of all-cause mortality, myocardial infarction, or stroke following a recent hospitalization for exacerbation of heart failure.
    El objetivo principal es demostrar que el rivaroxabán, administrado a pacientes con IC crónica y EC importante que reciben tratamiento según la pauta habitual, es superior al placebo para reducir el riesgo de la combinación de MCC, IM o ictus tras una hospitalización reciente por un agravamiento de la IC.
    E.2.2Secondary objectives of the trial
    The major secondary objectives are to compare rivaroxaban with placebo in addition to standard care in subjects with chronic heart failure and significant coronary artery disease following a recent hospitalization for exacerbation of heart failure in reducing the risk of the following outcomes:
    Composite of cardiovascular mortality and re-hospitalization for worsening heart failure
    Cardiovascular mortality
    Re-hospitalization for worsening of heart failure
    Re-hospitalization for cardiovascular events
    Los objetivos secundarios consisten en comparar el rivaroxabán con placebo, añadidos al tratamiento habitual en pacientes con IC crónica y EC importante tras una hospitalización reciente por agravamiento de la IC, en cuanto a la reducción del riesgo de los criterios de valoración siguientes:
    Combinación de muerte por causa CV y rehospitalización por empeoramiento de la IC.
    Muerte por causa CV.
    Rehospitalización por empeoramiento de la IC.
    Rehospitalización por episodios CV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject must have documented symptomatic chronic HF for at least 3 months prior to screening and must be hospitalized for exacerbation of chronic HF (index hospitalization) before randomization.
    Subject must have a documented LVEF of less than or equal to 40% within 3 months before randomization.
    Subject must have evidence of significant CAD.
    Subject must be medically stable in terms of their heart failure clinical status at the time of randomization.
    Subject must be receiving appropriate treatment for HF or CAD at the appropriate dosing per guidelines.
    Tener IC crónica sintomática documentada desde al menos 3 meses antes de la selección y estar hospitalizado por un agravamiento de la IC crónica (hospitalización de referencia) antes de la aleatorización.
    Tener una FEVI documentada igual o inferior al 40% en los 3 meses previos a la aleatorización o durante la hospitalización de referencia.
    Tener pruebas de EC importante.
    Encontrarse médicamente estable en cuanto al estado clínico de la insuficiencia cardíaca en el momento de la aleatorización. Estar recibiendo un tratamiento adecuado para la IC en dosis correctas según las directrices.
    E.4Principal exclusion criteria
    Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding.
    Subject has a severe concomitant disease or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
    Subject had a prior stroke within 90 days of randomization.
    Subject has been hospitalized longer than 21 days during the index hospitalization.
    Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously.
    Cualquier trastorno que, en opinión del investigador, contraindique el tratamiento anticoagulante o conlleve un riesgo inaceptable de hemorragia.
    Tener una enfermedad coexistente grave o cualquier condición por la cual, en opinión del investigador, la participación no seria el mejor de los intereses para el paciente o que pueda impedir, limitar o evitar la evaluación específica del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the first occurrence of death, MI, or stroke
    El término principal es el primer episodio de muerte, IM, o infarto
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization to global treatment end date (which is also the end of study visit)
    Desde la randomización (el cual es también el final de visitas del estudio)
    E.5.2Secondary end point(s)
    1) Composite of CV mortality and re-hospitalization for worsening of HF
    2) CV mortality
    3) Re-hospitalization for worsening of HF
    4) Re-hospitalization for CV events
    1)Combinación de muerte por causa CV y rehospitalización por empeoramiento de la IC.
    2)Muerte por causa CV.
    3)Rehospitalización por empeoramiento de la IC.
    4)Rehospitalización por episodios CV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomization to global treatment end date (which is also the end of study visit)
    Desde la randomización (el cual es también el final de visitas del estudio)
    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 Yes
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA142
    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
    Argentina
    Bulgaria
    China
    Czech Republic
    Germany
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    United States
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 1750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3250
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3100
    F.4.2.2In the whole clinical trial 5000
    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
    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 Decision2013-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-02
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