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    Summary
    EudraCT Number:2007-001626-27
    Sponsor's Protocol Code Number:CC-5013-CLL-002
    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:2008-12-09
    Trial 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 number2007-001626-27
    A.3Full title of the trial
    ESTUDIO FASE 3, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS PARA VALORAR LA EFICACIA Y LA SEGURIDAD DE LENALIDOMIDA (REVLIMID®) COMO TERAPIA DE MANTENIMIENTO EN PACIENTES CON LEUCEMIA LINFOCÍTICA CRÓNICA DE CÉLULAS B TRAS TRATAMIENTO DE SEGUNDA LÍNEA
    (EL ENSAYO CONTINUUM)
    A.3.2Name or abbreviated title of the trial where available
    The Continuum trial
    A.4.1Sponsor's protocol code numberCC-5013-CLL-002
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    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 Revlimid 10mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/494
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNLenalidomide
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.2.1.1.1Trade name Revlimid 5mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/494
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 INNLenalidomide
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/494
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form 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 INNLenalidomide
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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 Allopurinol Hexal 300
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNAllopurinol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Terapia de mantenimiento en pacientes con leucemia linfocítica crónica (LLC) de células B recidivante o refractaria que han alcanzado una respuesta al menos parcial (RP) con el tratamiento de segunda línea.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008978
    E.1.2Term Chronic lymphocytic leukemia refractory
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Para comparar la eficacia de lenalidomide versus placebo como terapia de mantenimiento.
    E.2.2Secondary objectives of the trial
    Para evaluar la seguridad de lenalidomide versus placebo como terapia de mantenimiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Debe entender y firmar voluntariamente un documento de consentimiento informado.
    2. Edad ≥ 18 años en el momento de firmar el documento de consentimiento informado.
    3. Capaz de cumplir el calendario de visitas del estudio y otros requisitos del protocolo.
    4. Debe tener un diagnóstico documentado de LLC de células B (normas IWCLL para el diagnóstico y tratamiento de la leucemia linfocítica crónica, [Hallek, 2008]).
    5. Debe haber sido tratado con un régimen con un análogo de la purina en el tratamiento de inducción de primera o segunda línea.
    6. Debe haber alcanzado una respuesta mínima de respuesta parcial (RP, RCi, RC y RC con ERM negativa) (normas IWCLL para el diagnóstico y tratamiento de la leucemia linfocítica crónica, [Hallek, 2008] Anexo 21.4) después de completar el tratamiento de inducción de segunda línea antes de la aleatorización (la documentación de la respuesta debe estar disponible). Se debe documentar la duración suficiente del tratamiento de inducción de segunda línea (p. ej., 3 ciclos de tratamiento, 6 semanas de alemtuzumab por vía intravenosa u 8 semanas de alemtuzumab por vía subcutánea, etc.).
    7. Debe haber completado el último ciclo de inducción de segunda línea no menos de 8 semanas (56 días) y no más de 16 semanas (112 días) antes de la aleatorización.
    8. Estado funcional según el Eastern Cooperative Oncology Group (ECOG) ≤ 2.
    9. Las mujeres en edad fértil (MEF)† deben:
    • Tener una prueba de embarazo negativa bajo supervisión médica antes de iniciar el tratamiento del estudio. Deben estar de acuerdo en repetir la prueba de embarazo a lo largo del estudio y al terminar el tratamiento del estudio (ver los detalles específicos del Anexo 21.9). Debe hacerse así incluso si la mujer practica una abstinencia sexual completa y mantenida.
    • Se comprometerá a mantener la abstinencia continuada de relaciones heterosexuales (lo que se revisará mensualmente) o aceptará usar, y será capaz de cumplirlo, un método anticonceptivo eficaz sin interrupción, 28 días antes de iniciar la administración del fármaco del estudio, durante el tratamiento del estudio (incluidas las interrupciones de la dosis) y durante 28 días después de suspender el tratamiento del estudio (ver los detalles en el Anexo 21.9).
    10. Los sujetos varones deben:
    • Aceptar el uso de preservativos durante el contacto sexual con una MEF, incluso si se han sometido a una vasectomía, durante todo el tratamiento con el fármaco del estudio, durante cualquier interrupción de la administración y después de terminar el tratamiento del estudio. (Ver los detalles específicos del Anexo 21.9).
    11. Estar de acuerdo en no donar semen durante el tratamiento con el fármaco del estudio y durante un periodo después de terminar dicho tratamiento (ver los detalles específicos en el Anexo 21.9).
    12. Todos los sujetos deben:
    • Entender que el fármaco del estudio podría tener un riesgo de teratogenia.
    • Estar de acuerdo en abstenerse de donar sangre mientras reciba el fármaco del estudio y después de suspenderlo. (Ver los detalles específicos del Anexo 21.9).
    • Estar de acuerdo en no compartir la medicación del estudio con otra persona.
    • Se informará a todos los sujetos sobre las precauciones frente al embarazo y los riesgos de la exposición fetal. Ver el Anexo 21.9.
    E.4Principal exclusion criteria
    1. Cualquier problema médico, anomalía analítica o enfermedad psiquiátrica graves que pudiera impedir que el sujeto firmase el documento de consentimiento informado.
    2. Infecciones activas que requieran antibióticos sistémicos.
    3. Infecciones sistémicas que no se hayan resuelto > 2 meses antes de iniciar el tratamiento con lenalidomida a pesar del tratamiento antiinfeccioso adecuado.
    4. Trasplante autólogo o alogénico de médula ósea como tratamiento de segunda línea.
    5. Mujeres embarazadas o en período de lactancia.
    6. Tratamiento sistémico de la LLC de células B en el intervalo entre el fin del último ciclo del tratamiento de inducción de segunda línea y la aleatorización.
    7. Participación en cualquier estudio clínico o haber tomado cualquier tratamiento en investigación por una enfermedad distinta de la LLC en los 28 días previos al inicio de la terapia de mantenimiento.
    8. Presencia conocida de abuso de alcohol o drogas.
    9. Afectación del sistema nervioso central (SNC) documentada por citología del líquido cefalorraquídeo o estudio radiológico. Se debe efectuar una punción lumbar en las dos semanas previas a la aleatorización en los sujetos que tengan signos o síntomas sospechosos de meningitis leucémica o antecedentes de meningitis leucémica.
    10. Antecedentes de procesos malignos, aparte de la LLC, a menos que el sujeto no haya tenido enfermedad durante ≥ 3 años. Las excepciones son las siguientes:
    • Carcinoma basocelular de la piel
    • Carcinoma epidermoide de la piel
    • Carcinoma de cuello uterino in situ
    • Carcinoma de mama in situ
    • Hallazgo histológico casual de un cáncer de próstata (estadio TNM T1a o T1b)
    11. Historia de insuficiencia renal que requiere diálisis.
    12. Infección conocida por el virus de la inmunodeficiencia humana (VIH), virus de la Hepatitis B (VHB) o virus de la Hepatitis C (VHC).
    13. Tratamiento previo con lenalidomida.
    14. Indicios de SLT según la definición de Cairo-Bishop de SLT analítico (Anexo 21.7) (los sujetos podrán ser incluidos tras la corrección de las anomalías electrolíticas).
    15. Cualquiera de las siguientes anomalías analíticas:
    • Aclaramiento de creatinina calculado (método de Cockroft-Gault) < 60 ml/min.
    • Recuento absoluto de neutrófilos (ANC) < 2.000/µl (2,0 x 109/l).
    • Recuento de plaquetas < 75.000/µl (75 x 109/l).
    • Aspartato aminotransferasa sérica (AST)/ transferasa glutámico-oxalacética sérica (SGOT) o alanina aminotransferasa (ALT) /transaminasa glutámico-pirúvica sérica (SGPT) > 3,0 x límite superior de la normalidad (LSN).
    • Bilirrubina sérica total > 2 mg/dl (con excepción del síndrome de Gilbert).
    16. Exantema de Grado 4 debido al tratamiento previo con talidomida.
    17. Hipertiroidismo o hipotiroidismo no controlado.
    18. Tromboembolia venosa en el último año.
    19. Neuropatía de Grado ≥ 2.
    20. Anemia hemolítica o trombocitopenia autoinmunitarias no controladas.
    21. Transformación de la enfermedad (activa) (como síndrome de Richter o leucemia prolinfocítica).
    E.5 End points
    E.5.1Primary end point(s)
    • Supervivencia global (SG)
    • Supervivencia sin progresión (SSP)
    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 Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    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 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA115
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 680
    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 Decision2009-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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