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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2010-019791-73
    Sponsor's Protocol Code Number:EFC11405
    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:2010-06-25
    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 number2010-019791-73
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar el beneficio clínico de Dronedarona 400 mg BID añadida a terapia estándar en pacientes con fibrilación auricular permanente y factores de riesgo adicionales
    _______________________________________________

    A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors
    A.3.2Name or abbreviated title of the trial where available
    Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)
    A.4.1Sponsor's protocol code numberEFC11405
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 nameDronedarona
    D.3.2Product code SR33589
    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 INNDRONEDARONE
    D.3.9.1CAS number 141626360
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibrilación auricular
    __________________

    Atrial Fibrillation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este ensayo es demostrar la eficacia de dronedarona en la prevención de los acontecimientos cardiovasculares mayores (ictus, embolismo arterial sistémico, infarto de miocardio o muerte cardiovascular) u hospitalización cardiovascular no programada o muerte por cualquier causa en pacientes con fibrilación auricular permanente y factores de riesgo adicionales).
    ----------------------------------------------------------
    Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation (AF) and additional risk factors
    E.2.2Secondary objectives of the trial
    Demostrar la eficacia de dronedarona en la prevención de muerte cardiovascular.
    --------------------------------------------------
    Demonstrate the efficacy of dronedarone in preventing cardiovascular death
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    España participará en el subestudio nº1
    1) Evaluation of whether physician access to a WEB-based nomogram for INR control improves the time in therapeutic range
    Date: 30 April 2010-Version: 1 Concerned countries : all. 2) Evaluation of the effect of dronedarone in patients with systolic dysfunction in the PALLAS Study Date: 30 April 2010-Version: 1 Concerned countries : Belgium, Germany, Netherlands, Italy 3) Measurement of quality of life in the PALLAS study
    Date 30 April 2010 -Version1
    E.3Principal inclusion criteria
    1.Pacientes en fibrilación auricular permanente definida por la presencia de todos los criterios siguientes:
    -Disponibilidad de un ECG de 12 derivaciones no más de 14 días antes de la aleatorización, que muestre que el paciente está en fibrilación auricular o flúter auricular
    -Disponibilidad de documentación (incluyendo tiras de ritmo o informe médico del ritmo) que muestren que el paciente estaba en fibrilación auricular o flúter auricular al menos 6 meses antes de la aleatorización
    -Sin evidencia de ritmo sinusal en el periodo entre estas dos documentaciones de fibrilación auricular
    -Decisión del paciente y del médico de dejar que la fibrilación auricular continúe sin realizar más esfuerzos para restaurar el ritmo sinusal
    2. Pacientes de 65 años de edad o mayores con al menos uno de los siguientes criterios de riesgo
    -Enfermedad arterial coronaria
    -Ictus o AIT previo (confirmado por un neurólogo)
    -Insuficiencia cardiaca sintomática
    -Fracción de eyección ventricular izquierda inferior o igual a 0,40
    -Enfermedad oclusiva arterial periférica
    -Edad de 75 años o mayores con hipertensión y diabetes mellitus
    3. Consentimiento informado por escrito firmado
    ---------------------------------------------------------
    Permanent AF defined by the presence of all of the following criteria:
    - Availability of one 12-lead ECG not more than 14 days prior to randomization showing that the patient is in AF or atrial flutter
    - Availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in AF or atrial flutter at least 6 months prior to randomization
    - No evidence of sinus rhythm in the period between these two documentations of AF
    - Patient and physician decision to allow AF to continue without further efforts to restore sinus rhythm
    Patients aged 65 years or older with at least one of the following risk criteria:
    - Coronary artery disease
    - Prior stroke or Transient Ischemic Attack (TIA)
    - Symptomatic heart failure
    - Left ventricular ejection fraction less or equal to 0.40
    - Peripheral arterial occlusive disease
    - Aged 75 years or older with both hypertension and diabetes mellitus
    E.4Principal exclusion criteria
    1.Criterios de exclusión relacionados con la metodología del estudio
    -Pacientes en fibrilación auricular paroxística
    -Pacientes en fibrilación auricular persistente sin una decisión de permitir que la fibrilación auricular continúe sin mayores esfuerzos para restaurar el ritmo sinusal
    -Pacientes con ablación del nódulo auriculoventricular o diagnosticados previamente con bloqueo AV de tercer grado permanente
    -Pacientes con un desfibrinados cardiaco implantado
    -Cualquier enfermedad o alteración no cardiovascular que pueda impedir la participación o limitar gravemente la supervivencia, incluyendo cáncer con metástasis y trasplante de órgano que precise supresión inmunológica
    -Participación anterior (2 meses previos) o actual en otro ensayo clínico con un fármaco en investigación (en desarrollo) o con un dispositivo en investigación
    -Participación previa en este ensayo
    -Tratamiento con dronedarona en los 3 meses previos a la aleatorización
    -Que el paciente sea el investigador o algún Sub-investigador, ayudante de la investigación, farmacéutico, coordinador del ensayo, otro miembro del equipo o familiar que en consecuencia esté directamente implicado en la realización del protocolo
    -Paciente posiblemente no cumplidor con los procedimientos del ensayo
    2.Criterios de exclusión relacionados con el conocimiento actual de dronedarona
    -Pacientes con insuficiencia cardiaca de clase IV de NYHA o clase III de NYHA inestable* reciente
    -Inestable*: intensificación de terapia para insuficiencia cardiaca (por ejemplo aumento de diuréticos , ECA /BRAs, o inotrópicos) debido al aumento de síntomas en el mes anterior a la aleatorización.
    -Bradicardia constante durante el día < 50 lpm sin funcionamiento de un marcapasos electrónico
    -Intervalo QT > 500 ms
    -Hipersensibilidad a la sustancia activa o a cualquiera de los excipientes
    -Necesidad de co-administración de inhibidores fuertes de CYP3A4, como ketoconazol, itraconazol voriconazol, telitromicina, claritromicina, nefazodona y ritonavir que determine exposición sistémica
    -Necesidad de co-administración de productos medicinales que inducen torsades de pointes como fenotiazidas, cisaprida, bepridil, antidepresivos tricíclicos, terfenadina y ciertos macrólidos orales, o antiarrítmicos de clase I y III)
    -Alteración hepática grave
    -Cualquier contraindicación adicional según la ficha técnica local de dronedarona (cuando esté disponible)
    --------------------------------------------------------
    - Paroxysmal AF
    - Persistent AF without a decision to allow AF to continue without further efforts to restore sinus rhythm
    - Heart failure of New-York Heart Association (NYHA) class IV or recent unstable NYHA class III
    E.5 End points
    E.5.1Primary end point(s)
    - Composite endpoint of first stroke, systemic arterial embolism, myocardial infarction or cardiovascular death
    - Composite endpoint of first unplanned cardiovascular hospitalization or death from any cause
    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 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 Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA251
    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 months1
    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 months1
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state162
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3925
    F.4.2.2In the whole clinical trial 10800
    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 Decision2010-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-21
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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