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    Summary
    EudraCT Number:2006-001139-23
    Sponsor's Protocol Code Number:L00070 IN 303 B0
    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:2006-05-11
    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 number2006-001139-23
    A.3Full title of the trial
    Ensayo en fase III de vinflunina más gemcitabina frente a paclitaxel más gemcitabina en pacientes con cáncer de mama irresecable, localmente recurrente o metastásico, tras quimioterapia adyuvante previa basada en antraciclinas
    A.4.1Sponsor's protocol code numberL00070 IN 303 B0
    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 SponsorPierre Fabre Médicament
    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 Information not present in EudraCT
    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 nameJAVLOR
    D.3.2Product code L0070
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVinflunine ditartrate
    D.3.9.2Current sponsor codeL0070
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name GEMZAR
    D.2.1.1.2Name of the Marketing Authorisation holderLilly
    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.3.1Product nameGEMZAR
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGemcitabine Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name TAXOL
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    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.3.1Product nameTAXOL
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaclitaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name GEMZAR
    D.2.1.1.2Name of the Marketing Authorisation holderLilly
    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.3.1Product nameGEMZAR
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGemcitabine Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Tratamiento de pacientes con cáncer de mama irresecable, localmente recurrente o metastásico, tras quimioterapia adyuvante basada en antraciclina o, si estuviera contraindicada, una quimioterapia sin antraciclina.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que la rama experimental de vinflunina más gemcitabina no es inferior a la rama de control de paclitaxel más gemcitabina en términos de supervivencia libre de progresión. Si se demuestra la no inferioridad tras este primer test, se llevará a cabo un segundo test para demostrar que la rama de vinflunina más gemcitabina es superior a la rama de paclitaxel más gemcitabina en términos de supervivencia libre de progresión.
    E.2.2Secondary objectives of the trial
    Comparar entre las dos rammas de tratamiento:
    - la tasa de respuesta tumoral,
    - la duración de la respuesta, duración del control de la enfermedad, tiempo hasta el fallo del tratamiento y tiempo hasta la primera respuesta,
    - la supervivencia global,
    - el perfil de seguridad,
    - la calidad de vida en relación con la salud mediante un cuestionario de calidad de vida.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Las pacientes deberán otorgar el consentimiento informado por escrito (firmado y fechado personalmente).
    - Edad entre 18 años y 75 años.
    - Mujeres que padecen carcinoma de la mama con confirmación histológica o citológica.
    - Las mujeres en edad fértil deberán utilizar un método anticonceptivo médicamente aceptado (es decir, anticonceptivos orales, dispositivos intrauterinos, preservativo) para evitar el embarazo durante los dos meses anteriores al inicio del tratamiento en estudio, durante el período del estudio y hasta tres meses después de la última dosis del tratamiento en estudio. Las mujeres en edad fértil deberán obtener un resultado negativo en el test de embarazo en suero u orina en las 72 horas anteriores al primer tratamiento del fármaco en estudio.
    - Enfermedad localmente recurrente o metastásica documentada no susceptible de cirugía o radioterapia con intención curativa.
    - Pacientes con enfermedad HER-2 negativa, valorada por IHC 0-1+ o FISH/ CISH negativo, en el tumor primario o en la localización metastásica, o bien estado HER-2 desconocido, siempre y cuando se disponga de una muestra del tumor para evaluación retrospectiva, si es pertinente.
    - Las pacientes habrán recibido anteriormente quimioterapia adyuvante basada en antraciclina con o sin un taxano o, en caso de contraindicación, quimioterapia sin antraciclinas con o sin un taxano, siempre y cuando haya habido un intervalo libre de enfermedad de más de 12 meses a partir de la finalización de la quimioterapia adyuvante.
    - El tratamiento hormonal previo está permitido en neoadyuvancia y/o adyuvancia y en el marco metastásico, siempre que esté documentada la progresión de la enfermedad, y el tratamiento haya finalizado antes de la randomización.
    - La radioterapia previa está permitida en <25% de la médula ósea y debe haber finalizado al menos 4 semanas antes de la randomización.
    - Pacientes con lesión mensurable o no mensurable de acuerdo con los criterios RECIST.
    - Expectativa de vida estimada superior o igual a 12 semanas.
    - Puntuación del estado funcional de Karnofsky mayor o igual al 70%.
    - Función hematológica adecuada, definida por un recuento absoluto de neutrófilos (RAN) > o = 1.5 x 109/L, recuento de plaquetas > o = 100 x109/L y hemoglobina > o =10 g/dL (en los 7 días anteriores a la primera administración del tratamiento).
    - Función hepática adecuada, definida por: bilirrubina total < o = 1.5 x límite superior de normalidad (LSN), AST y ALT < o = 2.5 x LSN o < o = 5 x LSN en caso de metástasis hepáticas, fosfatasa alcalina < o = 5 x LSN (en los 7 días anteriores a la primera administración del tratamiento).
    - Función renal adecuada, definida por: nivel de creatinina dentro de los valores normales o, en caso de haber un nivel de creatinina > LSN, aclaramiento de la creatinina calculado > o = 60 mL/min de acuerdo con la fórmula de Cockroft-Gault (en los 7 días anteriores a la primera administración del tratamiento).
    - Ausencia de cualquier situación psicológica, familiar, sociológica o geográfica que pueda dificultar el cumplimiento del protocolo del estudio y el programa de seguimiento; estas situaciones deberán valorarse antes de la randomización.
    - ECG sin alteraciones clínicamente importantes (en los 7 días anteriores a la primera administración del tratamiento).
    E.4Principal exclusion criteria
    - Pacientes que hayan recibido quimioterapia previa para la enfermedad metastásica o que hayan progresado mientras se encontraban recibiendo quimioterapia adyuvante o en un intervalo de 12 meses a partir de la finalización de la quimioterapia adyuvante.
    - Pacientes con metástasis cerebrales o afectación leptomeníngea conocidas o con evidencia clínica.
    - Cáncer de mama inflamatorio sin evidencia de enfermedad metastásica.
    - Pacientes que hayan recibido cualquier otro tratamiento experimental o tratamiento antineoplásico en los 30 días anteriores a la randomización, con excepción de tratamiento hormonal.
    - Tratamiento concomitante con cualquier otro tratamiento experimental o tratamiento antineoplásico.
    - Historia de segundo tumor maligno primario , con excepción de: carcinoma de mama bilateral, carcinoma in situ de cérvix, carcinoma cutáneo no melanomatoso adecuadamente tratado u otro tumor maligno tratado, como mínimo, 5 años antes sin evidencia de recidiva.
    - Pacientes que presenten como únicas lesiones tumorales cualquiera de las siguientes: derrame pleural maligno, linfangitis, lesiones quísticas, lesiones óseas o cualquier otra lesión que no se valore mediante técnicas de imagen o fotografía en color.
    - Pacientes con existencia previa de neuropatía periférica motora o sensitiva de grado >1 de acuerdo con los criterios CTCAE version 3.0.
    - Antecedentes de hipersensibilidad grave a los alcaloides de la vinca y/o a la gemcitabina y/o taxanos o cualquier contraindicación a alguno de los fármacos en estudio.
    - Mujeres gestantes o en periodo de lactancia.
    - Pacientes que presenten un grave trastorno médico concurrente no controlado, especialmente la hipercalciemia no controlada, insuficiencia cardiaca congestiva, hipertensión de alto riesgo no controlada, arritmia, angina de pecho o historia previa de infarto de miocardio en los 6 meses previos a la randomización.
    - Trasplante previo de médula ósea o infusión autóloga de células madre tras quimioterapia en altas dosis.
    - Terapia anterior con gemcitabina y/o alcaloides de la vinca.
    E.5 End points
    E.5.1Primary end point(s)
    - Supervivencia libre de progresión, que será calculada desde la fecha de randomización hasta la fecha de progresión o muerte (cualquiera que sea la causa de la muerte).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Véase el protocolo
    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 months54
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months54
    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 Information not present in EudraCT
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 746
    F.4.2.2In the whole clinical trial 994
    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)
    See protocol
    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 Decision2006-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-30
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