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    Summary
    EudraCT Number:2008-008719-25
    Sponsor's Protocol Code Number:CBAF312A2201
    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:2009-03-06
    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 number2008-008719-25
    A.3Full title of the trial
    Estudio fase II, a doble ciego, aleatorizado y multicéntrico, con esquema adaptativo de dosis, controlado con placebo y de grupos paralelos, para evaluar la eficacia, tolerabilidad y seguridad en base a parámetros de lesión observados mediante resonancia magnética, así como determinar la curva dosis - respuesta de BAF312 administrado oralmente en dosis única diaria en pacientes con Esclerosis Múltiple remitente recurrente.
    A.4.1Sponsor's protocol code numberCBAF312A2201
    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 SponsorNovartis Farmacéutica, S.A
    B.1.3.4CountrySpain
    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.3.2Product code BAF312
    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.3.9.2Current sponsor codeBAF312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 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.3.2Product code BAF312
    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.3.9.2Current sponsor codeBAF312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 3
    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.3.2Product code BAF312
    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.3.9.2Current sponsor codeBAF312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 4
    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.3.2Product code BAF312
    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.3.9.2Current sponsor codeBAF312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Esclerosis Múltiple remitente recurrente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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 estudio es evaluar la relación dosis-respuesta entre cinco dosis de BAF312 y placebo durante 3 meses de tratamiento en pacientes con EMRR, medida mediante el número de lesiones [RM] activas únicas combinadas (CUAL).
    E.2.2Secondary objectives of the trial
    - Evaluar la seguridad y tolerabilidad de BAF312 durante 6 meses y 3 meses de tratamiento en pacientes con EM
    - Evaluar la relación dosis-respuesta de BAF312 y placebo durante 6 meses de tratamiento en pacientes con EMRR, medida mediante CUAL
    - Estudiar el efecto de BAF312 en el número de recidivas y las medidas derivadas de las mismas
    - Estudiar la correlación de la evolución del recuento de linfocitos con la evolución paraclínica y curso clínico.
    - Determinar el efecto de BAF312 a los 6 y 3 meses de tratamiento en los parámetros de RM adicionales.
    - Determinar las concentraciones de BAF312 en plasma en estado de equilibrio en pacientes con EMRR
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estas evaluaciones únicamente se realizarán a los pacientes que acepten participar firmando el consentimiento informado aparte para biomarcadores exploratorios en sangre.
    Se facilitarán manuales de laboratorio con información detallada sobre la extracción, manejo y envío de las muestras.

    Para más detalles dirijase a la sección 7.6.2 del protocolo.
    E.3Principal inclusion criteria
    1.Los pacientes deben otorgar el consentimiento informado por escrito antes de llevar a cabo ninguna evaluación
    2.De 18 a 55 años de edad, ambas edades inclusive
    3.Hombre o mujer
    4.Las mujeres en edad fértil:
    ?deben tener un resultado negativo en la prueba de embarazo realizada en la Basal antes de ser incluidas en la Fase de Tratamiento Doble Ciego
    ?deberán utilizar simultáneamente dos métodos anticonceptivos eficaces ( entre ambos miembros de la pareja) durante el tratamiento y durante un mes o un ciclo menstrual, lo que dure más tiempo tras la retirada de la medicación del estudio
    ?si llevan 12 meses en estado postmenopáusico antes de la aleatorización o se han sometido a una intervención de esterilización quirúrgica (mediante histerectomía u ooforectomía bilateral, en caso de que esté documentada) no necesitan utilizar métodos anticonceptivos (para más información, véase el Apartado 8.3)
    5.Diagnóstico de EM según la definición de los criterios de McDonald revisados (véase el Apartado 4)
    6.Un curso remitente recurrente de la enfermedad con
    ?al menos 1 recidiva documentada durante el año anterior, o
    ?2 recidivas documentadas durante los 2 años anteriores, o
    ?una imagen de RM positiva realzada con Gd en la visita de selección (en caso de que la primera imagen de RM obtenida en la visita de selección sea negativa, se podrá realizar una segunda RM 1 mes después)
    7.Una puntuación en la escala ampliada de estado de discapacidad (EDSS) de 0 a 5 puntos, ambas inclusive, en la aleatorización
    8.Neurológicamente estable sin indicios de recidivas o tratamiento con corticoesteroides durante los 30 días previos a la aleatorización
    9.Pacientes que se nieguen a iniciar o a continuar el tratamiento con fármacos modificadores de la enfermedad disponibles para EM, por el motivo que sea, después de que el investigador les haya informado de sus beneficios respectivos y de los posibles acontecimientos adversos
    E.4Principal exclusion criteria
    1.Una manifestación de otro tipo de EM distinto de EMRR
    2.Antecedentes de enfermedad crónica del sistema inmunitario distinta de EM, o un síndrome de inmunodeficiencia conocido
    3.Antecedentes o presencia de enfermedad maligna (excepto carcinoma basocelular o carcinoma espinocelular (escamoso) de la piel tratado satisfactoriamente)
    4.Diagnóstico conocido o ?nuevo? de diabetes mellitus
    5.Diagnóstico de edema macular durante la fase de prealeatorización
    6.Infecciones bacterianas, víricas o fúngicas sistémicas activas, o diagnóstico de infección por SIDA, Hepatitis B, Hepatitis C definidas como pruebas de anticuerpos positivos a VIH, antígenos de superficie de la Hepatitis B o anticuerpos de la Hepatitis C, respectivamente
    7.Negativo para los anticuerpos IgG frente al virus varicela zóster en la Selección
    8.Han recibido cualquier vacuna viva o viva atenuada en los 2 meses anteriores a la aleatorización
    9.Han recibido irradiación linfoide total o trasplante de médula ósea
    10.Han sido tratados con:
    ?corticoesteroides u hormonas adrenocorticotrópicas en el mes anterior a la aleatorización
    ?IFN-? o acetato de glatiramero en los 3 meses anteriores a la aleatorización
    ?medicaciones inmunosupresoras como azatioprina o metotrexato en los 6 meses anteriores a la aleatorización
    ?inmunoglobulinas y/o anticuerpos monoclonales en los 6 meses anteriores a la aleatorización
    ?alemtuzumab, rituximab, cladribina, ciclofosfamida, mitoxantrona, u otros tratamientos inmunosupresores con efectos que puedan perdurar más de 6 meses, en cualquier momento
    11.Cualquier enfermedad médicamente inestable, evaluada por el médico tratante principal
    12.Cualquiera de las siguientes enfermedades cardiovasculares:
    ?infarto de miocardio en los 6 meses anteriores al reclutamiento o cardiopatía isquémica inestable actual
    ?antecedentes de enfermedad de Raynaud
    ?insuficiencia cardíaca en la Selección (Clase III, según la clasificación de la NYHA) o cualquier cardiopatía severa, según lo determine el investigador
    ?antecedentes de paro cardíaco
    ?antecedentes de bradicardia sintomática
    ?pulso en reposo <55 bpm antes de la aleatorización
    ?antecedentes de síndrome de disfunción sinusal o bloqueo cardíaco sinoatrial
    ?antecedentes o presencia de bloqueo AV de segundo grado o bloqueo AV de tercer grado o aumento del intervalo QTc > 440 mseg en el ECG de la Selección
    ?arritmia que requiera tratamiento actual con antiarrítmicos de Clase III
    ?hipertensión, no controlada con la medicación
    13.Cualquiera de las siguientes enfermedades pulmonares:
    ?enfermedad respiratoria grave o fibrosis pulmonar
    ?tuberculosis, excepto en el caso de antecedentes de tuberculosis tratada satisfactoriamente o antecedentes de tratamiento profiláctico tras reacción cutánea positiva a la PPD
    ?resultado anormal en la tomografía computerizada de alta resolución que sugiera enfermedad pulmonar activa
    ?resultados anormales en las Pruebas de la Función Pulmonar: FEV1 o FVC inferiores al 70% del valor pronosticado
    ?pacientes que reciban terapias crónicas para el asma
    14.Cualquiera de las siguientes hepatopatías:
    ?enfermedad hepática o biliar crónica
    ?bilirrubina total por encima del ULN, excepto en el contexto del síndrome de Gilbert
    ?bilirrubina conjugada por encima del ULN
    ?fosfatasa alcalina más de 1,5 veces por encima del ULN
    ?AST o SGOT, ALT o SGPT más de 2 veces por encima del ULN
    ?GGT más de 3 veces por encima del ULN
    15.Cualquiera de los siguientes valores anormales de laboratorio:
    ?creatinina sérica > 1,7 mg/dL
    ?recuento leucocitario < 3,500/mm3
    ?recuento de linfocitos < 800/mm3
    16.Cualquiera de los siguientes trastornos neurológicos/psiquiátricos:
    ?antecedentes de abuso de sustancias
    ?trastorno neurológico progresivo, distinto de EM
    17.No se le pueden realizar resonancias magnéticas
    18.No puede recibir medios de contraste de RM basados en gadolinio
    19.Participación en algún estudio de investigación clínica con terapia en investigación en los 3 meses anteriores a la aleatorización
    20.Antecedentes de hipersensibilidad a cualquiera de las medicaciones del estudio o a medicaciones de clase química similar
    21.Ser homozigoto para el CYP2C9*3, y negarse a realizarse las pruebas para el haplotipo CYP2C9*3
    22.Pacientes que estén utilizando medicaciones concomitantes que sean inhibidores o inductores de CYP2C9 fuertes o moderados.
    23.Mujeres embarazadas o en período de lactancia
    24.Antecedentes de terapia con modulador del receptor S1P
    25.Cualquier otra enfermedad o afección que pudiera interferir en la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal se define como el número mensual de lesiones activas únicas combinadas (CUAL) observadas mediante RM durante 3 meses de tratamiento.
    Las lesiones activas únicas combinadas se definen como nuevas lesiones realzadas con gadolinio [Gd] en imágenes de RM potenciadas en T1 o como lesiones nuevas o con crecimiento en imágenes de RM potenciadas en T2, sin doble recuento de lesiones.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    esquema adaptativo de dosis
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 years1
    E.8.9.1In the Member State concerned months7
    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 months7
    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) No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 275
    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)
    Los pacientes que completen la Fase de Tratamiento Doble Ciego podrán ser elegibles para participar en el estudio de la Fase de Extensión que se presentará como un protocolo independiente y con un nuevo número de EUDRACT.
    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 Decision2009-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-16
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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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