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    Summary
    EudraCT Number:2010-019247-19
    Sponsor's Protocol Code Number:DRONE_C_04629
    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:2010-07-02
    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 number2010-019247-19
    A.3Full title of the trial
    A Randomized, international, multi-center, open-label study to document pharmacokinetics and optimal timing of initiation of dronedarone TreatmEnt following long-term aMIodarone in patients with paroxysmal or perSistent Atrial Fibrillation whatever the reason for the change of treatment

    Estudio AleatoRizado, internacional, multicéntrico y abierto para conocer la farmacocinética y el inicio óptimo del TratamiEnto con dronedarona tras aMiodarona a largo plazo en pacientes con fibrilación auricular paroxística o perSistente, con independencia del motivo del cambio de tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    ARTEMIS AF Long-Term
    A.4.1Sponsor's protocol code numberDRONE_C_04629
    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 groupe
    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 Yes
    D.2.1.1.1Trade name MULTAQ 400 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS
    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.3.4Pharmaceutical 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 INNDRONEDARONA
    D.3.9.3Other descriptive nameDRONEDARONA
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibrilación auricular paroxística o persistente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    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
    Explorar los perfiles farmacocinéticos de dronedarona y SR35021 (metabolito activo) según los distintos calendarios de inicio del tratamiento con dronedarona
    E.2.2Secondary objectives of the trial
    • Investigar la posible interacción farmacocinética entre dronedarona y amiodarona.
    • Evaluar el índice de recurrencia de FA un mes y dos meses después de la aleatorización.
    • Evaluar la seguridad del cambio de amiodarona a dronedarona y la seguridad de dronedarona.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudio farmacogenético;
    fecha: 3-mayo 2010
    versión 1.0

    El objetico es investigar variantes alélicas de enzimas del metabolismo de los fármacos como factores intrínsecos asociados a variabilidad en la farmacocinética o farmacodinámica de dronedarona.
    E.3Principal inclusion criteria
    Principales criterios de inclusión en la selección:
    1)Hombre o mujer de 18 o más años de edad,
    2)Paciente ambulatorio,
    3)Paciente con FA paroxística o persistente que haya recibido amiodarona durante al menos 6 meses antes de la selección, y en tratamiento con 200 mg/día (al menos 5 días por semana) durante al menos los 2 meses previos a la selección,
    4)Paciente que requiera un cambio del tratamiento con amiodarona por cualquier motivo, pero sin toxicidad grave asociada a amiodarona (enfermedad pulmonar intersticial, toxicidad hepática o tiroidea),
    5)Paciente con al menos un factor de riesgo cardiovascular (es decir, edad > 70, hipertensión, diabetes, enfermedad cerebrovascular previa, diámetro de la aurícula izquierda &#8805; 50 mm o fracción de eyección del ventrículo izquierdo [FEVI] < 40%),
    6)Paciente con anticoagulación eficaz según las guías de la ACC/AHA/ESC,
    7)QTcB < 500 ms en el ECG de 12 derivaciones,
    8)Consentimiento informado por escrito.

    Principales criterios de inclusión antes de la aleatorización:
    1)Paciente en ritmo sinusal antes de la aleatorización
    2)Paciente con anticoagulación oral eficaz según las guías de la ACC/AHA/ESC de 2006, en el momento de la aleatorización y durante el periodo de estudio
    3)QTcB < 500 ms y PR < 280 ms en el ECG de 12 derivaciones,
    4)Paciente ambulatorio (sólo se permitirán hospitalizaciones de 48 h para una cardioversión programada).
    E.4Principal exclusion criteria
    Principales criterios generales de exclusión (en el protocolo se facilita la lista completa) en la selección (S) y en la aleatorización (A):
    • Contraindicación de la anticoagulación oral (S),
    • Cualquier episodio de FA confirmado que lleve a la inclusión en el estudio tras un trastorno agudo que se sepa que produce FA (S),
    • FA permanente en la que la cardioversión haya fracasado (S),
    • Bradicardia < 50 lpm en el ECG de 12 derivaciones (S, A),
    • Insuficiencia cardíaca clínicamente manifiesta (S, A):
    o insuficiencia cardíaca de clase III o IV de la New York Heart Association (NYHA),
    o o bien clase II de la NYHA con una descompensación reciente que requiera hospitalización o remisión a una clínica especializada en insuficiencia cardíaca,
    o o bien pacientes en situación hemodinámica inestable
    • Síndrome de Wolff-Parkinson-White (S),
    • Ablación por catéter previa para fibrilación auricular (S),
    • Ablación por catéter programada en las próximas 10 semanas (S).
    • Antecedentes previos de intolerancia o toxicidad por amiodarona (S),
    • Antecedentes de disfunción tiroidea (S),
    • Cualquier contraindicación según la ficha técnica de dronedarona:
    o Pacientes en los que sea obligatorio un tratamiento concomitante contraindicado (S, A) (consulte más detalles en el texto del protocolo):
    • inhibidores potentes del citocromo P450 (CYP3A4),
    • uso concomitante de fármacos o plantas medicinales que prolonguen el intervalo QT y puedan incrementar el riesgo de Torsade de Pointes,

    o Paciente previamente tratado con antiarrítmicos de clase I o clase III (incluido el sotalol) con excepción de amiodarona, si el antiarrítmico se tomó menos de una semana antes del día de la selección (si se tomó antes de una semana previo a la selección, puede incluirse al paciente) (S),
    E.5 End points
    E.5.1Primary end point(s)
    Niveles plasmáticos de dronedarona y su metabolito SR35021 (AUC0-12 horas y Cmáx).
    • en la aleatorización (basal),
    • 3 horas después de la primera dosis de dronedarona,
    • después de una semana de tratamiento con dronedarona (antes de la dosis de dronedarona),
    • después de dos semanas de tratamiento con dronedarona (antes de la dosis de dronedarona),
    • después de cuatro semanas de tratamiento con dronedarona (antes de la dosis de dronedarona),
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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
    Úlitma visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 165
    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 Decision2010-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-18
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