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    Summary
    EudraCT Number:2010-019514-24
    Sponsor's Protocol Code Number:M12-073
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 number2010-019514-24
    A.3Full title of the trial
    Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis.
    A.3.2Name or abbreviated title of the trial where available
    CONCERTO
    A.4.1Sponsor's protocol code numberM12-073
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 HUMIRA 40 mg solución inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES LTD.
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.3Other descriptive nameADALIMUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Yes
    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 MTX HEXAL Tablets
    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 INNMETOTREXATO
    D.3.9.1CAS number 59-05-2
    D.3.9.3Other descriptive nameMETHOTREXATE
    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: 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 MTX HEXAL Tablets
    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 INNMETHOTREXATE
    D.3.9.1CAS number 59-05-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 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 MTX HEXAL Tablets
    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 INNMETHOTREXATE
    D.3.9.1CAS number 59-05-2
    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.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*
    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
    Rheumatoid Arthritis. Artritis Reumatoide
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 y comparar la proporción de sujetos que alcanzan la actividad reducida de la enfermedad definida por una respuesta clínica (DAS28 (PCR) <3,2) en la semana 26 con cuatro pautas distintas de metotrexato en combinación con adalimumab para determinar la relación dosis-respuesta de metotrexato en pacientes con artritis reumatoide (AR) incipiente.
    El estudio también se ha diseñado para evaluar la farmacocinética y la seguridad de metotrexato y adalimumab administrados en combinación.
    E.2.2Secondary objectives of the trial
    * Respuesta definida por los criterios ACR 20/50/70/90/100 en la semana 26
    * &#916;mTSS en la semana 26
    *Proporción de sujetos sin progresión radiográfica (&#916;mTSS 0,5) en la semana 26
    *DAS28 (PCR) <2,6 en la semana 26
    *Cambio en el cuestionario HAQ-DI en la semana 26
    *Proporción de sujetos con un incremento en el HAQ-DI -0,22 en la semana 26
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    El análisis farmacogenético es opcional y exige el consentimiento previo del sujeto. Se podrán analizar muestras de ADN para investigar factores genéticos que contribuyan a la respuesta del paciente al tratamiento del estudio en cuanto a farmacocinética, farmacodinamia, eficacia, tolerabilidad y seguridad.
    E.3Principal inclusion criteria
    1. Sujetos varones y mujeres de 18 años o más.
    2. Diagnóstico de AR definida por los criterios de clasificación del ACR revisados en 1987 o por los nuevos criterios diagnósticos ACR/EULAR para AR de 2010 y duración de la enfermedad inferior a 1 año desde el diagnóstico realizado por un médico autorizado.
    3. Cumplimiento de los siguientes criterios:
    DAS28(CRP) 3,2 (sólo en la visita basal).
    Al menos 6 articulaciones inflamadas de 66 evaluadas (en las visitas de selección y basal).
    Al menos 8 articulaciones dolorosas al tacto de 68 evaluadas (en las visitas de selección y basal).
    PCR 1,5 mg/dl (sólo en la visita de selección), o VSG 28 mm/1 h (en las visitas de selección y basal).
    o Cumplimiento de al menos uno de los tres criterios siguientes:
    Positividad para el factor reumatoide (FR)
    Al menos una erosión ósea
    Positividad para anticuerpos anti-CCP
    4. En caso de ser mujer, la paciente no debe tener capacidad para procrear, situación definida como llevar al menos un año de posmenopausia (al menos un año desde la última menstruación) o haber sido esterilizada por métodos quirúrgicos (ligadura de trompas bilateral, ovariectomía bilateral o histerectomía) o, si tiene capacidad para procrear y lleva una vida sexual activa, debe utilizar un método anticonceptivo autorizado durante todo el estudio y hasta 6 meses después de la última dosis del fármaco del estudio.
    Preservativos, esponja, espumas, gelatinas, diafragma o dispositivo intrauterino (DIU).
    Anticonceptivos orales o intravaginales durante 90 días antes de la administración del fármaco del estudio.
    Pareja con vasectomía.
    5. Las mujeres en edad fértil deben presentar una prueba de embarazo en suero negativa en la visita de selección y una prueba de embarazo en orina negativa en la visita basal.
    6. El investigador principal considera que el sujeto se encuentra en buen estado general de salud según los resultados de la anamnesis, los análisis clínicos, la exploración física, la radiografía de tórax (RxT) y el electrocardiograma (ECG) de 12 derivaciones realizados durante la selección.
    7. Presentar un resultado negativo en la prueba de PPD (o equivalente) y en la RXT (proyecciones PA y lateral) en la selección. Si el sujeto tiene una prueba de PPD positiva (o equivalente), ha sufrido una reacción ulcerosa a la prueba de PPD en el pasado o tiene una radiografía de tórax indicativa de exposición previa a la tuberculosis, deberá iniciar y completar un mínimo de 2 semanas de tratamiento contra la tuberculosis o documentar la finalización de un ciclo de tratamiento antituberculoso.
    8. Ser capaz y estar dispuesto a otorgar el consentimiento informado por escrito y a cumplir los requisitos de este protocolo de estudio.
    9. Ser capaz y estar dispuesto a administrarse inyecciones subcutáneas (s.c.) o disponer de una persona cualificada que se las administre.
    E.4Principal exclusion criteria
    1. Exposición previa a cualquier tratamiento biológico sistémico, incluido el adalimumab.
    2. Tratamiento previo con > 1 fármaco antirreumático modificador de la enfermedad (FARME) o tratamiento previo con MTX.
    3. Tratamiento con corticosteroides interarticulares o parenterales en las cuatro semanas anteriores a la selección. Se permiten los corticosteroides inhalados o tópicos para afecciones estables.
    4. Cirugía articular en los dos meses anteriores (en las articulaciones que se evaluarán en el estudio)
    5. Diagnóstico de artritis crónica antes de los 17 años de edad.
    6. Hipersensibilidad documentada a adalimumab, MTX o sus excipientes.
    7. Sujetos que hayan recibido tratamiento con algún fármaco en investigación como mínimo en los 30 días o cinco semividas del fármaco (lo que sea más largo) previos a la visita basal.
    8. Antecedentes de insuficiencia cardíaca congestiva moderada o intensa (clase III o IV de la NYHA), accidente cerebrovascular reciente o cualquier otra enfermedad que, en opinión del investigador, haga que la participación en el protocolo suponga un riesgo para el sujeto.
    9. Antecedentes de enfermedad hematológica (p. ej., anemia grave, leucopenia, trombocitopenia), renal o hepática (p. ej., fibrosis, cirrosis, hepatitis) clínicamente importante.
    10. Antecedentes de enfermedad desmielinizante (incluida mielitis) o síntomas neurológicos indicativos de enfermedad desmielinizante.
    11. Presentar signos de displasia o neoplasia maligna (incluidos linfomas y leucemias) distinta del carcinoma espinocelular o basocelular no metastásico tratado de forma satisfactoria o del carcinoma in situ localizado del cuello uterino.
    12. Antecedentes de infección fúngica invasiva (p. ej., listeriosis o histoplasmosis), infección activa o crónica por el virus de la hepatitis B o C, infección por el virus de la inmunodeficiencia humana (VIH), síndrome de inmunodeficiencia, infecciones crónicas recidivantes o tuberculosis activa.
    13. Presentar una o varias infecciones que requieran tratamiento con antiinfecciosos por vía intravenosa (i.v.) en los 30 días previos a la visita basal o con antiinfecciosos por vía oral en los 14 días previos a la misma.
    14. Tratamiento actual o previsto con antirretrovirales en algún momento del estudio.
    15. Si el sujeto es de sexo femenino, estar embarazada o dando el pecho o tener la intención de quedarse embarazada durante el estudio o durante los 6 meses siguientes a la última dosis del fármaco del estudio; si es varón, tener la intención de engendrar un hijo durante el estudio o durante los 6 meses siguientes a la última dosis del fármaco del estudio.
    16. Prueba de embarazo positiva en las visitas de selección o basal.
    17. Antecedentes de alcoholismo o toxicomanía de importancia clínica en los últimos 12 meses.
    18. Anomalías de importancia clínica en los resultados de los análisis de selección, según la evaluación del investigador.
    19. El investigador, por cualquier motivo, considera que el sujeto no es un candidato adecuado para el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Proporción de sujetos que alcanzan la actividad reducida de la enfermedad definida por una respuesta clínica (DAS28 (PCR) <3,2) en la semana 26.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Voluntary consent to pharmacogenetic analysis.
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Dose escalation.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    As per the protocol, the end-of-study is defined as the date of the last subject's last visit or the actual date of follow-up contact, whichever is later.
    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 months6
    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 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 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 2010-11-30. Yes
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 380
    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 Decision2011-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-20
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