Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-000722-54
    Sponsor's Protocol Code Number:MDV3100-10
    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:2013-10-01
    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 number2013-000722-54
    A.3Full title of the trial
    A Phase 4, Randomized, Double Blind, Placebo Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer.
    Estudio de fase IV, aleatorizado, con doble enmascaramiento y controlado con placebo, del tratamiento continuado con enzalutamida tras la progresión en los pacientes con cáncer de próstata metastásico, resistente a la castración, que no han recibido nunca quimioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An International Study to Evaluate the effectiveness of continuing treatment of enzalutamide after PSA Progression in Patients who have not yet received chemotherapy.
    Estudio Internacional para evaluar la eficacia del tratamiento continuado con enzalutamida tras la progresión en los pacientes con cáncer de próstata metastásico, que no han recibido nunca quimioterapia
    A.4.1Sponsor's protocol code numberMDV3100-10
    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 SponsorMedivation, 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 supportMedivation, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedivation, Inc.
    B.5.2Functional name of contact pointMedical Officer
    B.5.3 Address:
    B.5.3.1Street Address525 Market Street, 36th Floor
    B.5.3.2Town/ citySan Francisco, CA
    B.5.3.3Post code94105
    B.5.3.4CountryUnited States
    B.5.4Telephone number14155433470
    B.5.5Fax number14155433411
    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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXtandi (enzalutamide)
    D.3.2Product code MDV3100
    D.3.4Pharmaceutical form Capsule, soft
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.2Current sponsor codeMDV3100
    D.3.9.3Other descriptive nameXtandi
    D.3.9.4EV Substance CodeSUB77412
    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 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.2.1.1.1Trade name ZYTIGA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZYTIGA (abiraterone acetate)
    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.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    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: 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.2.5The 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 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 INNPrednisone
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.3Other descriptive namePREDNISOLONE
    D.3.9.4EV Substance CodeSUB10018MIG
    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.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, soft
    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
    Patients With Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer.
    Pacientes con cáncer de próstata metastásico, resistente a la castración
    E.1.1.1Medical condition in easily understood language
    Prostate cancer.
    Cancer de Próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate 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
    To determine the efficacy of combination treatment with continued enzalutamide plus abiraterone acetate (abiraterone) and prednisone (or prednisolone) compared with placebo plus abiraterone and prednisone as measured by progression free survival (PFS).
    Determinar la eficacia del tratamiento asociado con enzalutamida continuada, más acetato de abiraterona (abiraterona) y prednisona (o prednisolona), en comparación con placebo, más abiraterona y prednisona, según la medición de la supervivencia sin progresión (SSP)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of combination treatment with continued enzalutamide plus abiraterone and prednisone compared with placebo plus abiraterone and prednisone after PSA progression on treatment with enzalutamide in patients with chemotherapy naïve metastatic CRPC on the following: Time to PSA progression, PSA response, objective response rate, rate of pain progression, time to first use of subsequent antineoplastic therapy for prostate cancer, quality of life and safety.
    Evaluar el efecto del tratamiento asociado con enzalutamida continuada más abiraterona y prednisona, en comparación con placebo más abiraterona y prednisona, posterior a la progresión del PSA, con el tratamiento con enzalutamida, en los pacientes con CPRC metastásico, en los parámetros siguientes: el tiempo hasta la progresión del PSA;la respuesta del PSA;
    la tasa de respuesta objetiva; la tasa de la progresión del dolor;
    el tiempo hasta el primer tratamiento antineoplásico posterior para el cáncer de próstata; la calidad de vida y la seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 years or older and willing and able to provide informed consent;
    Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
    Presence of metastatic disease as assessed by CT/MRI and/or whole body radionuclide bone scan;
    Throughout study, ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
    Testosterone ? 1.73 nmol/L (? 50 ng/dL) at screening;
    Progressive disease on androgen deprivation therapy at screening defined as a minimum of 3 sequential rising PSA values (PSA1 < PSA2 < PSA3) assessed by the local laboratory (local PSA) with an interval of ? 1 week between each determination;
    The most recent local PSA and the initial screening PSA assessed by the central laboratory should be ? 2 µg/L (? 2 ng/mL). In the event of prior androgen receptor inhibitor use, the most recent local PSA and the initial screening PSA assessed by the central laboratory (central PSA) must be obtained at least 4 weeks after the last dose of the androgen receptor inhibitor.
    Tener 18 años o más y estar dispuestos a prestar su consentimiento informado,
    2. Padecer adenocarcinoma de próstata, confirmado mediante histología o citología, sin diferenciación neuroendocrina, ni células en sello, ni características de células pequeñas.
    3. La presencia de una enfermedad metastásica evaluada por TAC/RMN y/o gammagrafía ósea con radionúclidos de cuerpo entero
    Durante todo el estudio, someterse a un tratamiento de deprivación androgénica continua con un agonista/antagonista de la GnRH o a una orquiectomía bilateral previa (castración quirúrgica o médica).
    5. Testosterona ? 1,73 nmol/l (? 50 ng/dl) durante la selección.
    6. Se define la enfermedad progresiva con un tratamiento de deprivación androgénica durante la selección, como un mínimo de tres valores consecutivos del PSA en aumento (PSA1 < PSA2 < PSA3), con la evaluación por un laboratorio local (PSA local), con un intervalo ? 1 semana entre cada determinación.
    7. El PSA local más reciente y el PSA del periodo de selección inicial, evaluado por el laboratorio central, deberían ser ? 2 ?g/l (? 2 ng/ml). En caso de un uso anterior del inhibidor de receptor de andrógenos, el PSA local más reciente y el PSA del periodo de selección inicial evaluado por el laboratorio central (PSA central), deben obtenerse al menos 4 semanas después de la última dosis del inhibidor del receptor de andrógenos.
    E.4Principal exclusion criteria
    Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
    Medical contraindication to prednisone use; Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5 alpha reductase inhibitors) or biologic therapy for prostate cancer (other than denosumab, GnRH agonist/antagonist therapy, or corticosteroid therapy) within 4 weeks of screening;
    Use of an investigational agent within 4 weeks of the screening visit;
    Current or previously treated brain metastasis or active leptomeningeal disease.
    Quimioterapia citotóxica anterior, aminoglutetimida, ketoconazol, acetato de abiraterona o enzalutamida para el tratamiento del cáncer de próstata, o participación en un ensayo clínico de un medicamento en fase de investigación que inhiba el receptor de andrógenos o la síntesis de andrógenos (a menos que el tratamiento fuera un placebo).
    2. Contraindicación médica al uso de prednisona.
    3. Hormonoterapia (p. ej., inhibidores de receptor de andrógenos, inhibidores de la 5-? reductasa) o tratamiento biológico para el cáncer de próstata (aparte del tratamiento con denosumab, con agonistas/antagonistas de la GnRH o con corticosteroides) durante las 4 semanas anteriores a la selección.
    4. Uso de un fármaco en fase de investigación en las 4 semanas anteriores a la visita de selección.
    5. Metástasis cerebral tratada en la actualidad o previamente, o enfermedad leptomeníngea activa.
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival
    Progresion de la supervivencia
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression, unequivocal clinical progression, or death on study (death within 112 days of treatment discontinuation without objective evidence of radiographic progression), whichever occurs first.
    La SSP se define como el periodo que va de la aleatorización a la prueba objetiva más precoz de progresión radiográfica, a la progresión clínica inequívoca o al fallecimiento durante el estudio (fallecimiento dentro de los 112 días tras la interrupción del tratamiento sin prueba objetiva de progresión radiográfica), lo que ocurra en primer lugar.
    E.5.2Secondary end point(s)
    Time to PSA progression
    Tiempo hasta la progresión del PSA:
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to PSA progression is defined as the time from randomization to the date of the first PSA value demonstrating progression, which must be subsequently confirmed.
    El tiempo hasta la progresión del PSA se define como el tiempo desde la aleatorización hasta la fecha del primer valor del PSA confirmado que demuestre que existe progresión
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Quality of life.
    Calidad de vida
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Period 1: enzalutamide open-label treatment
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Russian Federation
    Slovakia
    Spain
    Sweden
    United Kingdom
    United States
    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
    Study drugs will continue until disease progression (as defined by radiographic imaging or unequivocal clinical progression), intolerable toxicity, patient withdrawal, or death on study, whichever occurs first.
    Se continuará la administración de los fármacos investigados hasta que se produzca una evolución de la enfermedad (según definan las imágenes radiográficas o la progresión clínica inequívoca), una toxicidad intolerable, una retirada del paciente o el fallecimiento durante el estudio, lo que ocurra en primer lugar.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 325
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 324
    F.4.2.2In the whole clinical trial 500
    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)
    Standard of care for patients with progressive metastatic prostate cancer
    Segun la practica clínica habitual en pacientes con cancer de prostata metastásico
    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 Decision2013-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 08 19:24:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA