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    Summary
    EudraCT Number:2011-000621-80
    Sponsor's Protocol Code Number:212082BCA2001
    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:2011-06-13
    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 number2011-000621-80
    A.3Full title of the trial
    Randomized, Open-Label Study of Abiraterone Acetate (JNJ 212082) plus Prednisone/ Prednisolone with or without Exemestane in Postmenopausal Women with ER+ Metastatic Breast Cancer Progressing after Letrozole or Anastrozole Therapy
    Estudio aleatorizado abierto de acetato de abiraterona (JNJ-212082)
    más prednisona con o sin exemestano en mujeres posmenopáusicas con cáncer de mama metastásico ER+ que muestran progresión después del tratamiento con letrozol o anastrozol.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Un estudio de acetato de abiraterona más prednisona con o sin exemestano en mujeres posmenopáusicas con cáncer de mama metastásico con receptor de estrógemos positivo (ER+) que muestran progresión después del tratamiento con letrozol o anastrozol.
    A.4.1Sponsor's protocol code number212082BCA2001
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen-Biologics BV-Clinical Registry Group
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number..31715242166.
    B.5.5Fax number..31715242110.
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameAcetato de Abiraterona
    D.3.2Product code JNJ-212082
    D.3.4Pharmaceutical form Tablet
    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 INNAbiraterone acetate
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeJNJ-212082
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.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.2.5The 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 namePrednisolona
    D.3.4Pharmaceutical form Tablet
    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 INNPrednisolone
    D.3.9.1CAS number 50-24-8
    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) 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.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 Yes
    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 nameExemestano
    D.3.4Pharmaceutical form Coated tablet
    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 INNExemestane
    D.3.9.1CAS number 107868-30-4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Breast Cancer
    Cancer de mama metastásico
    E.1.1.1Medical condition in easily understood language
    Cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 es evaluar la seguridad y la eficacia del acetato de abiraterona más prednisona y del acetato de abiraterona más prednisona en combinación con exemestano, cada uno en comparación con el exemestano en monoterapia, en mujeres posmenopáusicas con cáncer de mama metastásico ER+ que muestran progresión después del tratamiento con letrozol o anastrozol.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son evaluar el acetato de abiraterona más prednisona y el acetato de abiraterona más prednisona en combinación con exemestano, cada uno en comparación con el exemestano en monoterapia, en mujeres posmenopáusicas con cáncer de mama metastásico ER+ que muestran progresión después del tratamiento con letrozol o anastrozol, en relación con los siguientes parámetros:
    Supervivencia global
    Tasas de respuesta global
    Resultados comunicados por el paciente (PROs), EORTC-C30, EQ-5D-5L y la escala de intensidad del dolor del BPI-SF
    Marcadores endocrinos tales como el estradiol, la testosterona, la estrona y otros biomarcadores
    Caracterización de la farmacocinética (FC) de la abiraterona y del exemestano.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.
    Mujeres 18 años de edad y posmenopáusicas de acuerdo con uno de los siguientes criterios:

    ovariectomía quirúrgica bilateral

    edad 60 años

    edad < 60 años, con amenorrea 24 meses y concentraciones de folitropina y lutropina dentro del intervalo posmenopáusico
    2.
    cáncer de mama metastásico ER+, Her2-, confirmado en los 7 días previos a la aleatorización con una muestra de tejido FFIP de un foco primario o metastásico del cáncer de mama, que recidiva durante o en los 6 meses siguientes a la interrupción del tratamiento con anastrozol o letrozol como tratamiento adyuvante o metastásico; puede incluirse a sujetos con afectación exclusivamente ósea.
    3.
    La enfermedad debe haber sido sensible al tratamiento con anastrozol o letrozol antes de la progresión de la enfermedad. La sensibilidad al tratamiento con anastrozol o letrozol se define como enfermedad estable o una respuesta mejor durante 6 meses como tratamiento metastásico o como la ausencia de recidiva durante 2 años como tratamiento adyuvante.
    4.
    No más de dos líneas previas de tratamiento metastásico, de las cuales no más de una consistió en quimioterapia. [Nota: El tratamiento combinado simultáneo se considera una línea de tratamiento.]
    5.
    Puntuación de capacidad funcional del Eastern Cooperative Oncology Group (ECOG) 1
    6.
    Valores analíticos durante la selección:

    hemoglobina 10,0 g/dl

    neutrófilos 1,5 x 109/l

    plaquetas 100 x 109/l

    bilirrubina total 1,5 x límite superior de la normalidad (LSN)

    alanina-aminotransferasa (ALT) y aspartato-aminotransferasa (AST) 2,5 x LSN

    fosfatasa alcalina 6 x LSN a menos que existan metástasis óseas sin trastorno hepático

    creatinina sérica < 1,5 x LSN o aclaramiento de creatinina 50 ml/min

    potasio sérico 3,5 mM

    albúmina sérica 3,0 g/dl

    tiempo de protrombina (TP) y tiempo de tromboplastina parcial (TTP) dentro de los límites de la normalidad [Excepción: el TP y el cociente internacional normalizado (CIN) estarán anormalmente prolongados en sujetos tratados con warfarina.]
    7.
    Presión arterial sistólica < 160 mm Hg y una presión arterial diastólica < 95 mm Hg. [Nota: Se permite la hipertensión controlada con tratamiento antihipertensivo.]
    8.
    Fracción de eyección cardíaca 50% medida mediante ventriculografía isotópica en equilibrio o ecocardiografía en las 4 semanas previas a la aleatorización.
    9.
    Si el sujeto está recibiendo un bisfosfonato o denosumab, la dosis deberá haber permanecido estable durante al menos 2 semanas antes de la aleatorización.
    10.
    Disposición y capacidad para cumplir las prohibiciones y restricciones especificadas en este protocolo.
    11.
    Haber firmado un documento de consentimiento informado en las 4 semanas previas a la aleatorización en el que se indique que la paciente entiende el objetivo del estudio y los procedimientos que éste exige y que está dispuesta a participar en él.
    12.
    Haber firmado el documento de consentimiento informado en las 4 semanas previas a la aleatorización para la investigación farmacogenómica indicando su disposición a participar en la parte de farmacogenómica del estudio, si lo permite la normativa local. [Nota: La negativa a otorgar el consentimiento para esta parte del estudio no excluirá al sujeto de participar en este estudio clínico.]
    E.4Principal exclusion criteria
    1.
    Tratamiento previo con exemestano, ketoconazol, aminoglutetimida o un inhibidor de la CYP17.
    2.
    Inmunoterapia antineoplásica o tratamiento con un fármaco experimental en las 4 semanas previas a la aleatorización, o radioterapia antineoplásica (excepto de carácter paliativo) o tratamiento hormonal antineoplásico en las 2 semanas previas a la aleatorización. [Nota: Los sujetos potenciales no deben haber recibido anastrozol, letrozol, fulvestrant o cualquier quimioterapia durante al menos 2 semanas (bevacizumab durante al menos 3 semanas) antes de la entrada en el estudio.]
    3.
    Enfermedad grave no maligna o no controlada, incluida una infección activa o no controlada.
    4.
    Signos clínicos o bioquímicos de hiperaldosteronismo o hipopituitarismo.
    5.
    Todo trastorno que, en opinión del investigador, pondría en peligro el bienestar de la paciente o que podría impedir, limitar o constituir un factor de confusión en las evaluaciones especificadas en el protocolo.
    6.
    Cirugía mayor torácica o abdominal o lesión traumática importante en las 4 semanas previas a la aleatorización o cirugía programada durante la participación en el estudio o en las 4 semanas siguientes a la última dosis de la medicación del estudio. [Nota: No se excluirá del estudio a las pacientes con intervenciones quirúrgicas programadas que se llevarán a cabo bajo anestesia local.]
    7.
    Reacción adversa persistente de grado 2 por cualquier causa. [Nota: Se permiten la alopecia inducida por la quimioterapia y la neuropatía periférica de grado 2.]
    8.
    Enfermedad leptomeníngea o enfermedad del sistema nervioso central sintomática.
    9.
    Trastorno digestivo que interfiere en la absorción de los fármacos del estudio.
    10.
    Enfermedad autoinmunitaria activa o no controlada que puede requerir tratamiento con corticosteroides.
    11.
    Hepatitis viral activa o sintomática, o hepatopatía crónica.
    12.
    Antecedentes de cardiopatía clínicamente significativa, es decir, infarto de miocardio o episodio trombótico arterial en los 6 meses anteriores, angina grave o inestable, o cardiopatía de grado III o IV de la New York Heart Association.
    13.
    Alergia, hipersensibilidad o intolerancia conocidas al acetato de abiraterona, al exemestano, a la prednisona o a sus excipientes.
    14.
    Contraindicaciones para el uso de exemestano o prednisona conforme a la ficha técnica local.
    15.
    Haber recibido un fármaco experimental (incluidas las vacunas experimentales) o haber utilizado un producto sanitario experimental invasivo en las 4 semanas previas a la primera dosis prevista de la medicación del estudio o participación actual en un estudio de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Hasta 1.5 años aproximadamente.
    E.5.2Secondary end point(s)
    1. Supervivencia global
    2. Tasa de respuesta global al tratamiento
    3. Resultados comunicados por el paciente
    4. Farmacodinamia
    5. Farmacocinética
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Hasta 3.5 años aproximadamente
    2. Hasta 1.5 años
    3. Hasta 3.5 años aproximadamente
    4. Hasta 1.5 años aproximadamente
    5. 4 meses aproximadamente
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluación de biomarcadores
    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 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.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Belgium
    France
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Ukraine
    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
    El último seguimiento del último paciente que esté participando en el estudio.
    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 months6
    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 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.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 300
    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)
    Los sujetos deben entrar en la fase de seguimiento independientemente del motivo de la retirada de la medicación del estudio y deberán ser vigilados cada 3 meses (± 7 días) hasta 36 meses (3 años), o hasta el fallecimiento, la pérdida del contacto durante el seguimiento, la retirada del consentimiento o la interrupción del desarrollo de acetato de abiraterona para esta indicación.
    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 Decision2011-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    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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