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    Summary
    EudraCT Number:2012-002181-12
    Sponsor's Protocol Code Number:8457-010
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-23
    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 number2012-002181-12
    A.3Full title of the trial
    A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-alpha Therapy
    Ensayo clínico de fase IIa multicéntrico mundial aleatorizado, doble ciego, controlado con placebo y con grupos paralelos, de prueba de concepto para evaluar la seguridad, la tolerabilidad y la eficacia de MK-8457 en sujetos con artritis reumatoide activa y respuesta insuficiente o intolerancia al tratamiento anti-TNF-alpha
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA
    Ensayo clínico de fase IIa para evaluar la seguridad, la tolerabilidad y la eficacia en sujetos con artritis reumatoide
    A.3.2Name or abbreviated title of the trial where available
    A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA
    Ensayo clínico de fase IIa para evaluar la seguridad, la tolerabilidad y la eficacia en sujetos con
    A.4.1Sponsor's protocol code number8457-010
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointElena Llorente Galeán
    B.5.3 Address:
    B.5.3.1Street AddressC/Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34609086450
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMK-8457
    D.3.2Product code MK-8457
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNMK8457
    D.3.9.2Current sponsor codeMK8457
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Active rheumatoid arthritis
    Artritis reumatoide activa.
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis due to overactive immune system
    Artritis reumatoide activa.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine the effects of MK-8457 100 mg BID compared to placebo over 12 weeks of treatment as measured by ACR20 response.
    -To determine the safety and tolerability of MK-8457 100 mg BID compared to placebo over 12 weeks of treatment.
    -Comparar los efectos de 100 mg 2 v/d de MK-8457 y un placebo durante 12 semanas de tratamiento, medidos por la respuesta ACR20.
    -Comparar la seguridad y la tolerabilidad de 100 mg 2 v/d de MK-8457 y el placebo durante 12 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    Key Secondary: To determine the effects of MK-8457 100 mg BID compared to placebo as measured by ACR20 at Week 24; DAS28CRP change from baseline at Week 12; and ACR50 at Week 12.

    - Base Study: To determine the effects of MK-8457 100 mg BID compared to placebo as measured by
    change from baseline in DAS28CRP at Week 24; ACR50 at Week 24; and HAQ change
    from baseline at Weeks 12 and 24.

    Safety Extension: To assess the safety and tolerability of MK-8457 during the safety extension period
    through Week 100.
    Objetivo secundario clave: Comparar los efectos de 100 mg 2 v/d de MK-8457 y del placebo, determinados mediante la ACR20 en la semana 24; el cambio de la DAS28PCR respecto a la basal en la semana 12, y la ACR50 en la semana 12.
    Estudio base:
    Comparar los efectos de 100 mg 2 v/d de MK-8457 y del placebo, determinados por el cambio de la DAS28PCR respecto a la basal en la semana 24; la ACR50 en la semana 24, y el cambio del HAQ respecto al basal en las semanas 12 y 24.
    Extensión de seguridad:
    Valorar la seguridad y la tolerabilidad de MK-8457 durante el período de extensión de seguridad hasta la semana 100.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CI Version 00_ Genetic and future samples( 28/06/2012)
    CI Versión 00_ Genético y Muestras Futuras (28/06/2012)
    E.3Principal inclusion criteria
    -Subject must be > or = to 18 years of age on the day of signing the informed consent.
    -Subject has a diagnosis of RA for at least 6 months prior to screening.
    -Subject has active RA as defined by the presence of 6 swollen joints (of 66 joint count) AND 6 tender joints (of 68 joint count) at screening (Visit 1) and baseline (Visit 2).
    -Subject has a C-reactive protein (CRP) blood level > 0.9 mg/dL from the central reference laboratory at screening.
    -Subject is anti-cyclic citrullinated antibody positive and/or rheumatoid factor positive at screening.
    -Subject is ACR functional Class I, II, or III.
    -Subject must have received MTX for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening (15-25 mg/wk for regions outside of Asia, and 6-25 mg/week for Asia). The subject's dose of weekly MTX must remain stable through week 24 of the study.
    -Subject must have either failed treatment with 1 or 2 anti-TNF alpha therapies or was intolerant to anti-TNF alpha therapy prior to screening. For subjects who have failed therapy, the treatment with anti-TNF therapies must have been for at least 3 months.
    Note: The inadequate response or intolerance to anti-TNF therapy will be defined by the Investigator's assessment and will be recorded. Typically, an inadequate response is based on clinical reasons (e.g., no improvement or worsening of RA). Lack of access to the medication or financial reasons are not considered an inadequate response


    (Read the rest in the protocol)
    -El sujeto deberá tener ?18 años de edad en el día en que firme el consentimiento informado.
    -El sujeto tiene un diagnóstico de AR desde al menos 6 meses antes de la selección
    -El sujeto sufre AR activa, definida por la presencia de ?6 articulaciones hinchadas (de un total de 66) Y ?6 articulaciones dolorosas (de un total de 68) en la selección (visita 1) y el momento basal (visita 2).
    -El sujeto tiene una concentración en sangre de proteína C reactiva (PCR) >0,9 mg/dl según el laboratorio de referencia central en la selección
    -El sujeto da positivo en la prueba para anticuerpos antiproteína citrulinada (ACPA) o la del factor reumatoide o ambas en la selección
    -El sujeto muestra una clase funcional I, II o III de la ARA
    -El sujeto deberá haber recibido MTX durante un mínimo de 3 meses antes de la selección con una dosis semanal estable regionalmente adecuada durante al menos 4 semanas antes de la selección (15-25 mg/semana en regiones fuera de Asia y 6-25 mg/semana en Asia). La dosis semanal de MTX del sujeto deberá permanecer estable hasta la semana 24 del estudio.
    -El sujeto deberá no haber respondido al tratamiento con 1 ó 2 tratamientos anti-TNF-alpha o mostró intolerancia al tratamiento anti-TNF-alpha antes de la selección. En el caso de los sujetos en quienes haya fracasado el tratamiento, el tratamiento con fármacos anti-TNF-alpha deberá haber durado al menos 3 meses.
    -Nota: La respuesta insuficiente o la intolerancia al tratamiento anti-TNF la definirá la valoración del investigador y se registrará. Normalmente, una respuesta insuficiente se basa en motivos clínicos (p. ej., ausencia de mejoría o empeoramiento de la AR). La falta de acceso a la medicación o los motivos económicos no se consideran respuesta insuficiente.


    Leer el resto en el protocolo.
    E.4Principal exclusion criteria
    -Subject has inflammatory disease other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.
    -Previous exposure to fostamatinib or other splenic tyrosine kinase (SYK) inhibitors.
    -Previous exposure to any biological agents other than anti-TNF therapeutic agents, including but not limited to abatacept, tocilizumab, rituximab or other biological agents used for the treatment of RA.
    -Subject has received any treatment (listed in the table below) more recently than the indicated washout period prior to randomization.
    Washout Period for Medications Prior to Randomization Medications, Supplements, and Other Substances Washout Period Prior to Randomization
    Anti-TNF-alpha Therapies:
    Adalimumab-8 weeks
    Certolizumab-8 weeks
    Etanercept-4 weeks
    Golimumab-8 weeks
    Infliximab- 8 weeks
    Cyclosporine, corticosteroids¹ (parenteral, intra-articular), azathioprine, sulfasalazine, hydroxychloroquine--4 weeks
    Leflunomide² -8 weeks unless subject undergoes standard cholestyramine or activated charcoal washout in which case 4 weeks washout is required.
    Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents 3 months
    -Live vaccinations 1 month Investigational medications
    -30 days or 5 half lives of the investigational agent whichever is longer Bacille Calmette-Guerin (BCG)
    -vaccination 1 month
    1 Subjects will be allowed to take stable doses of oral corticosteroids as specified in inclusion criterion #10; i.e., subjects must be on a stable dose of ?10 mg prednisone per day (or equivalent) for at least 2 weeks prior to first administration of study medications.
    2 Subjects may be allowed to use leflunomide instead of methotrexate on or after Week 24 of study treatment.
    -El sujeto sufre una enfermedad inflamatoria distinta a la AR incluidas, entre otras, la artritis psoriásica, la espondilitis anquilosante, el lupus eritematoso diseminado o la enfermedad de Lyme.
    -Exposición previa al fostamatinib o a otros inhibidores de la tirosina cinasa esplénicos (SYK).
    -Exposición previa a cualquier fármaco biológico distinto de los fármacos anti-TNF incluidos, entre otros, abatacept, tocilizumab, rituximab u otros fármacos biológicos utilizados para el tratamiento de la AR.
    El sujeto ha recibido cualquiera de los tratamientos enumerados en la tabla 2-1 sin que haya transcurrido el período de lavado indicado antes de la aleatorización.
    Período de lavado de la medicación antes de la aleatorización:

    Tratamientos anti-TNF:
    Adalimumab -8 semanas
    Certolizumab-8 semanas
    Etanercept-4 semanas
    Golimumab-8 semanas
    Infliximab-8 semanas
    Ciclosporina, corticosteroides¹ (parenterales, intraarticulares), azatioprina, sulfasalazina, hidroxicloroquina-4 semanas
    Leflunomida2-8 semanas a menos que el sujeto se someta a lavado habitual de colestiramina o carbón activado, caso en el que se precisan 4 semanas de lavado.
    Fármacos citotóxicos como el clorambucilo, la ciclofosfamida, la mostaza nitrogenada u otros agentes alquilantes-3 meses
    Vacunas de microorganismos vivos-1 mes
    Medicamentos en investigación-30 días o 5 semividas del fármaco en investigación, lo que sea más prolongado.
    Vacuna de bacilo de Calmette-Guérin (BCG)- 1 mes
    1 Se permitirá que los sujetos tomen dosis estables de corticosteroides orales según se especifica en el criterio de inclusión 10; es decir, los sujetos deberán haber recibido una dosis estable de ?10 mg de prednisona al día (o su equivalente) durante al menos 2 semanas antes de la primera administración de las medicaciones del estudio.
    2 Puede permitirse a los sujetos utilizar leflunomida en lugar de metotrexato en o después de la semana 24 de tratamiento del estudio.

    Leer el resto en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    -The primary efficacy endpoint is the proportion of subjects achieving ACR20 response at Week 12.
    The primary safety endpoints are:
    -Percentage of subjects with adverse experiences;
    -Change from baseline in laboratory parameters;
    -Change from baseline in vital signs parameters;
    -Change in blood pressure from predose to 1 hour, 2 hours and 3 hours after the morning study drug dose at Week 2 and Week 12; and
    -Average change in blood pressure from predose in the 3 hours time period after am study drug dose at Week 2 and Week 12
    -El Criterio de valoración de la eficacia principal es la proporción de sujetos que logran una respuesta ACR20 en la semana 12
    Criterios de valoración de la seguridad principales:

    -Porcentaje de sujetos con acontecimientos adversos
    -Cambio de los parámetros analíticos respecto al momento basal en cada punto temporal especificado en el procedimiento del estudio
    -Cambio de las constantes vitales respecto al momento basal en cada punto temporal especificado en el procedimiento del estudio
    -Cambio de la presión arterial desde antes de la administración hasta 1 hora, 2 horas y 3 horas después de la dosis del fármaco del estudio en las semanas 2 y 12
    -Cambio medio de la presión arterial respecto a antes de la administración en el período de 3 horas después de la dosis del fármaco del estudio en las semanas 2 y 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are:

    -Proportion of subjects achieving ACR20 response at Week 24;
    -Change from baseline in DAS28CRP at Week 12; and
    -Proportion of subjects achieving ACR50 response at Week 12.

    Other secondary efficacy endpoints that will be evaluated include:
    -Change from baseline in DAS28CRP at Week 24;
    -Proportion of subjects achieving ACR50 response at Week 24; and
    -?Change from baseline in HAQ at Weeks 12 and 24.
    Safety endpoints will also be evaluated through Week 100 of the safety extension.
    Criterios de valoración de la eficacia secundarios clave
    -Proporción de sujetos que logran una respuesta ACR20 en la semana 24
    -Cambio de la DAS28CRP en la semana 12 respecto a la basal
    -Proporción de sujetos que logran una respuesta ACR50 en la semana 12

    Criterios de valoración de la eficacia secundarios
    -Cambio de la DAS28CRP en la semana 24 respecto a la basal
    -Proporción de sujetos que logran una respuesta ACR50 en la semana 24
    -Cambio del HAQ en las semanas 12 y 24 respecto al basal

    Los criterios de valoración de la seguridad serán también evaluados en la semana 100 de la extensión de seguridad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 12 and 24
    Semana 12 y 24
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Colombia
    Denmark
    France
    Greece
    Hungary
    Italy
    New Zealand
    Peru
    Poland
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    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
    LVLS (Post-Study Visit is the scheduled last visit for patients.)
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months2
    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.1.2.1Number of subjects for this age range: 178
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 178
    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)
    No additional follow up monitoring or treatment is planned after the patient completes the Post-Study Visit, performed 14 days after the last dose of study medication.
    No aplica.
    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 Decision2012-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-12
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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