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    Summary
    EudraCT Number:2013-003839-30
    Sponsor's Protocol Code Number:D081CC00006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-05-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-003839-30
    A.3Full title of the trial
    A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
    Ensayo fase III, multicéntrico, aleatorizado, doble ciego, de grupos
    paralelos, controlado con placebo, para evaluar la eficacia y la seguridad de
    olaparib frente a placebo como tratamiento adyuvante de pacientes con
    cáncer de mama HER2 negativo de alto riesgo y mutaciones germinales de
    BRCA1/2, que han finalizado el tratamiento local y la quimioterapia
    neoadyuvante o adyuvante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib as adjuvant treatment in patients with germline BRCA mutated high risk HER2 negative primary breast cancer.
    Olaparib como tratamiento adyuvante en pacientes con cáncer de mama HER2 negativo de alto riesgo y mutaciones germinales de
    BRCA1/2
    A.3.2Name or abbreviated title of the trial where available
    Olympia
    Olympia
    A.4.1Sponsor's protocol code numberD081CC00006
    A.5.4Other Identifiers
    Name:Protocol Study CodeNumber:BIG 6-13
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmaceutica Spain, S.A.
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache 56
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900 162 001
    B.5.6E-mailinformacionEECC-spain@astrazeneca.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 nameolaparib
    D.3.2Product code AZD2281
    D.3.4Pharmaceutical form Film-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 INNOLAPARIB
    D.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 nameolaparib
    D.3.2Product code AZD2281
    D.3.4Pharmaceutical form Film-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 INNOLAPARIB
    D.3.9.1CAS number 763113-22-0
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Adjuvant breast cancer
    Adyuvancia en cáncer de mama
    E.1.1.1Medical condition in easily understood language
    Breast cancer
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term 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
    Efficacy of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS).
    evaluar el efecto del tratamiento adyuvante con olaparib sobre la supervivencia libre de enfermedad infiltrante (SLEI).
    E.2.2Secondary objectives of the trial
    - Efficacy of adjuvant treatment with olaparib on overall survival (OS).
    - Efficacy of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS)
    - Efficacy of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer.
    - Efficacy of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale.
    - Efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
    - Evaluar el efecto del tratamiento adyuvante con olaparib sobre la supervivencia global (SG)
    - Evaluar el efecto de tratamiento adyuvante con olaparib sobre la supervivencia libre de enfermedad a distancia (SLED)
    - Evaluar el efecto del tratamiento adyuvante con olaparib sobre la incidencia de nuevo cáncer primario de mama infiltrante y/o nuevo cáncer epitelial de ovario
    - Evaluar el efecto de olaparib sobre los resultados comunicados por los pacientes usando la escala FACIT-fatiga y la escala de calidad de vida relacionada con la salud (CdV-RS QLQ-C30) de la EORTC
    - Evaluar la eficacia de olaparib en pacientes identificados como portadores de una variante deletérea o de la que se sospeche que sea deletérea en cualquiera de los genes BRCA usando variantes identificadas con estudios de mutación germinal de BRCA actuales y futuros (análisis de secuenciación de genes y de grandes reordenamientos)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast.
    -Invasive TNBC
    -Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
    - Completed adequate breast and axilla surgery. Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
    -ECOG 0-1.
    - Adenocarcinoma de mama primario infiltrante, triple negativo, no metastásico, confirmado histológicamente
    - CMTN infiltrante
    - Mutación documentada de BRCA1 o BRCA2 que se predice que es deletérea o se sospecha que es deletérea (se sabe o se predice que es perjudicial/conduce a pérdida de la función de la proteína)
    - Sometidos a cirugía adecuada de la mama y la axila
    - Han terminado al menos 6 ciclos de quimioterapia neoadyuvante o adyuvante con antraciclinas, taxanos o la combinación de ambos. Se permite el tratamiento potencialmente curativo con platino para cáncer previo (p. ej., ovario) o como tratamiento adyuvante o neoadyuvante para el cáncer de mama
    - Estado funcional del ECOG 0-1
    E.4Principal exclusion criteria
    - Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the
    excipients of study treatment.
    - Patients with second primary cancer, EXCEPTIONS: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ? 5 years prior to randomization. More than one course of chemotherapy for previous malignancies.
    -Resting ECG with QTc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long QT syndrome. If ECG demonstrates QTc >470 msec, patient will be eligible only if repeat ECG demonstrates QTc ?470 msec.
    - Concomitant use of known potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.-Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing
    - pacientes con algún tratamiento previo con PARP inhibidor, incluido olaparib y /o hipersensibilidad conocida a cualquiera de excipientes del tratamiento del estudio.
    -Pacientes con un segundo cáncer primario, excepciones: carcinoma cutáneo no melanoma tratado adecuadamente, cáncer de cérvix in situ tratado curativamente, carcinoma ductal in situ (CDIS) de la mama, carcinoma endometrial de grado 1, estadio 1 u otros tumores sólidos incluidos los linfomas (sin afectación de la médula ósea) tratados de forma curativa sin pruebas de enfermedad durante ? 5 años antes de la aleatorización. Más de una línea de quimioterapia para tumores malignos previos (p. ej., cáncer de mama o cáncer de ovario hace > 5 años tratado con quimioterapia adyuvante)
    -ECG en reposo con QTc > 470 ms detectado en 2 o más momentos dentro de un periodo de 24 h o antecedentes familiares de síndrome de QT largo. Si el ECG demuestra QTc >470 ms, el paciente será elegible sólo si la repetición del ECG demuestra QTc ?470 ms
    - Uso simultáneo de inhibidores potentes conocidos de CYP3A4 como ketoconazol, itraconazol, ritonavir, indinavir, saquinavir, telitromicina, claritromicina y nelfinavir
    - Transfusiones de sangre entera en los últimos 120 días antes de la entrada en el ensayo que puedan interferir con las pruebas de gBRCA
    E.5 End points
    E.5.1Primary end point(s)
    Invasive Disease Free Survival (IDFS)
    supervivencia libre de enfermedad invasiva
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recurrent/new cancers assessments will be performed at day 1, weeks 12, 24, 38, 52. In follow-up period in year 2 every 3 months, in year 3, 4,5 every 6 months and year 6 to 10 every 12 months. MRI to be performed every 12 months after the 6 months scan.
    Recurrentes / nuevas evaluaciones de los cánceres se llevarán a cabo en el día 1, semana 12, 24, 38, 52. En período de seguimiento en el año 2 cada 3 meses, en el año 3, 4,5 cada 6 meses y de 6 a 10 años cada 12 meses. Resonancia magnética para realizarse cada 12 meses después de la exploración 6 meses.
    E.5.2Secondary end point(s)
    1. Efficacy of adjuvant treatment with olaparib on overall survival (OS).
    2. Efficacy of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS)
    3. Efficacy of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer.
    4. Efficacy of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale.
    5. Efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
    - Evaluar el efecto del tratamiento adyuvante con olaparib sobre la supervivencia global (SG)
    - Evaluar el efecto de tratamiento adyuvante con olaparib sobre la supervivencia libre de enfermedad a distancia (SLED)
    - Evaluar el efecto del tratamiento adyuvante con olaparib sobre la incidencia de nuevo cáncer primario de mama infiltrante y/o nuevo cáncer epitelial de ovario
    - Evaluar el efecto de olaparib sobre los resultados comunicados por los pacientes usando la escala FACIT-fatiga y la escala de calidad de vida relacionada con la salud (CdV-RS QLQ-C30) de la EORTC
    - Evaluar la eficacia de olaparib en pacientes identificados como portadores de una variante deletérea o de la que se sospeche que sea deletérea en cualquiera de los genes BRCA usando variantes identificadas con estudios de mutación germinal de BRCA actuales y futuros (análisis de secuenciación de genes y de grandes reordenamientos)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1, 15, 29 week 8,12,16,20,24,38,52, 30 days after last dose of study medication, in year 2 every 3 months, in year 3, 4,5 every 6 months and above year 6 every 12 months
    2 & 3.Physical examination will be performed at day 1, weeks 12, 24, 38, 52. In follow-up period in year 2 every 3 months, in year 3, 4,5 every 6 months and year 6 to 10 every 12 months. MRI to be performed every 12 months after the 6 months scan
    4.EORTC QLQ-C30 and FACIT-Fatigue scale will be collected prior randomization, at weeks 24 and 52 and also every 6 months during the 2nd year post randomisation (months 18 and 24 only).
    5. Within 15 years from last subject last visit
    1. Días 1, 15, 29, semana 8,12,16,20, 24, 38, 52, 30 días después de l última dosis de medicación del estudio, en el año 2 cada 3 meses, en el año 3, 4, cada 6 meses y a partir del año 6 cada 12 meses.
    2&3. los exámenes físicos se realizaran el día 1, semana 12, 24, 38, 52. en el periodo de seguimiento en el año 2 cada tres meses, en el año 3, 4, 5 cada 6 meses y desde el año 6 hasta el año 10 cada 12 meses. MRI se realizaran cada 12 meses después de 6 meses de exploración.
    4. EORTC QLQ-C30 and FACIT-escala de fatiga, se realizaran antes de la randomización, en la semana 24 y 52 y también cada 6 meses durante el segundo año de la randomización ( solo los meses 18 y 24)
    5. dentro de los 15 años tras la ultima visita del último paciente
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other 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 concerned41
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA224
    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
    Argentina
    Australia
    Austria
    Belgium
    Canada
    China
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    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
    Last subject last visit
    última visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years15
    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 years15
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 660
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 660
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 873
    F.4.2.2In the whole clinical trial 1320
    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
    tratamiento estandar
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Breast International Group (BIG)
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-14
    P. End of Trial
    P.End of Trial StatusOngoing
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