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    Summary
    EudraCT Number:2010-019638-28
    Sponsor's Protocol Code Number:PMR-EC-1211
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-10-29
    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 number2010-019638-28
    A.3Full title of the trial
    INVESTIGATING NEW ONSET DIABETES MELLITUS IN KIDNEY TRANSPLANT RECIPIENTS RECEIVING AN ADVAGRAF-BASED IMMUNOSUPPRESSIVE REGIMEN WITH OR WITHOUT CORTICOSTEROIDS ?
    A MULTICENTER, TWO ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY - ESTUDIO CLÍNICO MULTICÉNTRICO, ALEATORIZADO Y ABIERTO, CON DOS RAMAS DE TRATAMIENTO PARA INVESTIGAR LA DIABETES MELLITUS DE NOVO EN RECEPTORES DE TRASPLANTE RENAL QUE ESTÉN RECIBIENDO UNA PAUTA INMUNOSUPRESORA BASADA EN ADVAGRAF, CON O SIN CORTICOSTEROIDES
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE
    A.4.1Sponsor's protocol code numberPMR-EC-1211
    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 SponsorAstellas Pharma Europe 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 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 ADVAGRAF 0,5 mg cápsulas duras de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE, B.V.
    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 Prolonged-release capsule, hard
    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 INNTACROLIMUS
    D.3.9.3Other descriptive nameTACROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.1.1.1Trade name ADVAGRAF 1 mg cápsulas duras de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE, B.V.
    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 Prolonged-release capsule, hard
    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 INNTACROLIMUS
    D.3.9.3Other descriptive nameTACROLIMUS
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.1.1.1Trade name ADVAGRAF 3 mg cápsulas duras de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE, B.V.
    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 Prolonged-release capsule, hard
    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 INNTACROLIMUS
    D.3.9.3Other descriptive nameTACROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.2.1.1.1Trade name ADVAGRAF 5 mg cápsulas duras de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA EUROPE, B.V.
    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 Prolonged-release capsule, hard
    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 INNTACROLIMUS
    D.3.9.3Other descriptive nameTACROLIMUS
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Prophylaxis of rejection in kidney allograft recipients (by immunosuppression)- Profilaxis del rechazo en pacientes receptores de un trasplante renal.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.
    E.1.2Level LLT
    E.1.2Classification code 10050436
    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 comparar la incidencia de diabetes mellitus de novo entre los grupos 1 y 2, según los criterios de la Asociación Americana de Diabetes, en cualquier momento hasta las 24 semanas postrasplante renal. Grupo1: Advagraf + Basiliximab + MMF + Esteroids (durante los primeros 10 días)
    Grupo2: Advagraf + Basiliximab + MMF + Esteroids (solo en bolo intraoperatorio opcional)
    E.2.2Secondary objectives of the trial
    Comparar los perfiles de eficacia y seguridad de los dos regímenes de tratamiento entre sí.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Edad &#8805;18 años.
    2. Paciente con enfermedad renal terminal que es candidato adecuado para un trasplante renal primario o retrasplante (a menos que haya perdido el injerto por rechazo en los primeros 6 meses).
    3. Pacientes receptores de un trasplante renal de un cadáver o un donante vivo (HLA no idéntico) con grupo ABO compatible.
    4. Las mujeres en edad fértil deben tener una prueba de embarazo sérica o urinaria negativa en el momento de la inclusión y deben comprometerse a seguir un control de natalidad altamente eficaz durante el estudio. Un método de control de natalidad eficaz se define como aquel que asocia una tasa de fracaso baja (CPMP/ICH/286/95 modificado), de menos del 1% al año, cuando se utiliza de forma constante y correcta, como pueden ser los implantes, los inyectables, los anticonceptivos orales combinados, algunos DIU, la abstinencia sexual o la pareja vasectomizada.
    5. Pacientes capaces de comprender el objetivo y los riesgos del estudio, que han sido totalmente informados y que den su consentimiento informado por escrito (es necesario tener el formulario de consentimiento informado firmado).
    E.4Principal exclusion criteria
    1.El paciente recibe o ha recibido previamente un trasplante de órgano diferente del renal.
    2. Tiempo de isquemia fría del riñón donante >30 horas.
    3. Estudio de reactividad de anticuerpos (PRA) >20%.
    4. Pérdida del trasplante renal previo en el periodo de un año, por motivos inmunológicos.
    5. El paciente recibe un injerto de un donante a corazón parado diferente a la categoría 3 de Maastricht (retirada del soporte vital en espera de la parada cardiaca).
    6. El paciente padece una enfermedad hepática significativa, definida como una elevación continuada de SGPT/ALT y/o SGOT/AST y/o niveles totales de bilirrubina &#8805;2 veces el límite superior del intervalo del centro o paciente que reciba un injerto de un donante con hepatitis C o B.
    7. Diagnóstico de diabetes mellitus previo al trasplante (tratada con medicación recetada o controlada con dieta) o evidencia de una prueba TTOG previa positiva en el historial de los pacientes o diagnóstico previo de diabetes gestacional o HbA1C basal &#8805; 6,5 mmol/L.
    8. El paciente requiere iniciar una terapia secuencial o paralela con preparados de anticuerpos inmunosupresores.
    9. El paciente requiere dosificación continuada con un fármaco inmunosupresor sistémico antes del trasplante (p. ej., por lupus, glomerulonefritis focal segmentaria, etc.), aparte de los niveles mínimos de inmunosupresores tras el fracaso de un trasplante previo sin nefrectomía.
    10. Cuando el médico considere que es necesario el tratamiento a largo plazo con esteroides para la prevención de la enfermedad renal recurrente autoinmune o si el paciente requiere dosificación continuada con corticosteroides durante el estudio por cualquier otra patología.
    11. El paciente presenta infecciones concomitantes significativas no controladas y/o diarrea severa, vómitos, malabsorción activa del tracto gastrointestinal superior o úlcera péptica activa.
    12. Mujeres embarazadas o madres lactantes.
    13. Paciente o donante VIH-positivo.
    14. Intolerancia o alergia conocida a tacrolimus, antibióticos macrólidos, corticosteroides, Basiliximab, Micofenolato Mofetil o cualquiera de los excipientes del producto.
    15. Evidencia de cáncer en los últimos 5 años, aparte del carcinoma de células basales o escamosas.
    16. Paciente que participa en la actualidad en otro ensayo clínico y/o ha recibido un fármaco en investigación en los 28 días previos a la aleatorización.
    17. Cualquier tipo de abuso de sustancias, trastorno psiquiátrico u otro problema que, en opinión del investigador, pudiese complicar la comunicación con el investigador
    18. Poca probabilidad de que el paciente acuda a las visitas programadas en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal de este estudio es comparar la incidencia de diabetes mellitus de novo entre los grupos 1 y 2, según los criterios de la Asociación Americana de Diabetes, en cualquier momento hasta las 24 semanas postrasplante renal.
    1. HbA1C &#8805; 6,5% en la visita de la semana 12 o después de la misma. La prueba se realizará en un laboratorio, utilizando un método con certificación NGSP y de forma estandarizada con la prueba DCCT.
    O
    2. GPA (Glucosa Plasmática en Ayunas) &#8805; 126 mg/dl (7,0 mmol/l). Se define como ayunas la ausencia de ingesta calórica durante al menos las 8 horas previas a la toma de la muestra de sangre.*
    O
    3. Glucemia a las 2 h &#8805; 200 mg/dl (11,1 mmol/l) durante una prueba TTOG. La prueba debe realizarse como describe la Organización Mundial de la Salud, utilizando una carga de glucosa que contenga el equivalente a 75 g de glucosa anhidra disuelta en agua.*
    O
    4. Síntomas de hiperglucemia y una glucemia puntualcrisis de hiperglucemia &#8805; 200 mg/dl (11,1 mmol/l). Se define como “puntualcrisis” cualquier momento del día, sin tener en cuenta el tiempo transcurrido desde la última comida. Los síntomas clásicos de hiperglucemia son poliuria, polidipsia y pérdida de peso inexplicable.

    * En ausencia de hiperglucemia inequívoca, los criterios 2) y 3) deberán confirmarse repitiendo la misma prueba &#8805; 30 días después del resultado positivo inicial. No es necesario
    repetir la prueba en los casos 1) y 4). Un único resultado de HbA1C &#8805; 6,5% en la semana 12 o posteriormente, o de hiperglucemia inequívoca (4) es suficiente para confirmar el diagnóstico de NODAT.

    En los casos 2) y 3), el diagnóstico se considerará en el momento de la primera prueba que demuestre los criterios anteriores solo si se confirma mediante una segunda lectura con la misma prueba, o si se ha iniciado el tratamiento para la diabetes
    Según el protocolo, la HbA1C se medirá en la visita inicial, la semana 12 y la semana 24. La prueba TTOG se hará en la semana 8 y de nuevo en la semana 24. La glucosa se medirá en todas las visitas del estudio. El investigador podría realizar pruebas adicionales utilizando los métodos anteriores, a su propia consideración.
    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 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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    El final del estudio se define como la última valoración definida por protocolo del último paciente (visita de fin de estudio o visita de seguimiento en los casos de retirada).
    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 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 state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 950
    F.4.2.2In the whole clinical trial 1166
    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 Decision2011-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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