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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2012-004319-29
    Sponsor's Protocol Code Number:20120283
    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:2013-04-09
    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 number2012-004319-29
    A.3Full title of the trial
    A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared with Trastuzumab in Subjects with HER2 Positive Early Breast Cancer
    Estudio de fase 3, aleatorizado, doble ciego, para evaluar la eficacia y seguridad de ABP 980 frente a trastuzumab en pacientes con cáncer de mama precoz HER2 positivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The trial is designed to determine the efficacy and safety of ABP 980 compared with Trastuzumab in subjects with HER2 positive early breast cancer
    El estudio está diseñado para evaluar la eficacia y la seguridad de ABP 980 frente a Trastuzumab en pacientes con cáncer de mama precoz HER2 positivo.
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code number20120283
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfointernational@amgen.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 nameABP 980
    D.3.2Product code ABP 980
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABP 980
    D.3.9.2Current sponsor codeABP 980
    D.3.9.3Other descriptive namebiosimilar product to trastuzumab
    D.3.9.4EV Substance CodeSUB12612MIG
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 Yes
    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 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.2.1.1.1Trade name Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHerceptin (trastuzumab)
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehumanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture
    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
    HER2 Positive Early Breast Cancer
    Cáncer de mama precoz HER2 positivo.
    E.1.1.1Medical condition in easily understood language
    HER2 Positive Early Breast Cancer
    Cáncer de mama precoz HER2 positivo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065430
    E.1.2Term HER-2 positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the treatment effect of ABP 980 with trastuzumab on pathologic complete response (pCR) in women with early breast cancer
    Comparar el efecto del tratamiento de ABP 980 con trastuzumab en la pCR en mujeres con cáncer de mama incipiente HER2 positivo.
    E.2.2Secondary objectives of the trial
    To assess the safety, tolerability, and immunogenicity of ABP 980 compared with trastuzumab
    Evaluar la seguridad, tolerabilidad e inmunogenicidad de ABP 980 en comparación con trastuzumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Females ?18 years of age
    . Histologically confirmed invasive breast cancer
    . Planning for surgical resection of breast tumor and sentinel node (SN) or axillary lymph node resection
    . Planning neoadjuvant chemotherapy
    HER2 positive disease defined as:
    . 3+ overexpression by immunohistochemistry (IHC) or
    . HER2 amplification by fluorescence in situ hybridization (FISH)
    . Measurable disease (assessment method used in order of priority: ultrasound, mammography, MRI, or physical examination) in the breast after diagnostic biopsy, defined as longest diameter ? 2.0 cm
    . Known ER and PR hormone receptor status at study entry
    . Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    . Left ventricular ejection fraction (LVEF) of ? 55% by 2D echocardiogram
    . Normal bone marrow function as defined by:
    . absolute neutrophil count (ANC) > 1.5 x 10^9 g/dL (1,500/µL);
    . platelets > 100 x 10^9 g/dL (100,000/µL);
    . hemoglobin > 10.0 g/dL.

    . Normal hepatic function as defined by:
    total bilirubin within normal institutional limits; aspartate aminotransferase (AST) and alanine aminotransferase (ALT);
    < 2.5 × the upper limit of normal (ULN);
    subjects with an elevated unconjugated bilirubin (Gilbert's syndrome) will be eligible if hepatic enzymes and function are otherwise within normal limits (ie, AST, ALT, and Alkaline Phosphatase are within normal limits), and there is no evidence of hemolysis.
    . Normal renal function as defined by creatinine < 1.5 × ULN or estimated creatinine clearance (CrCl) ? 50 mL/min calculated by the Cockcroft-Gault method
    . Subjects must sign an IRB/EC-approved informed consent form before any study specific procedures
    . Mujeres ?18 años de edad
    . Cáncer de mama invasivo confirmado histológicamente
    . Planificación de resección quirúrgica del tumor de mama y el ganglio centinela (GC) o resección de los ganglios linfáticos axilares
    . Planificación de quimioterapia neoadyuvante
    . Enfermedad HER2 positiva definido como:
    . sobreexpresión 3+ por inmunohistoquímica (IHC); o
    . amplificación HER2 por hibridación fluorescente in situ (FISH).
    . Enfermedad medible (método de evaluación utilizado en orden de prioridad: ecografía, mamografía, RM o exploración física) en la mama después de biopsia diagnóstica, definida como diámetro más largo ?2,0 cm
    . Estado de los receptores hormonales ER y PR conocido en la incorporación al estudio
    . Estado funcional del Grupo de Colaboración Oncológico del Este (ECOG) de 0 o 1
    . Fracción de eyección ventricular izquierda (FEVI) de ? 55 % por ecocardiograma 2D
    . Función normal de la médula ósea definida por:
    . recuento absoluto de neutrófilos (RAN) > 1,5 x 109 g/dl (1500/µl);
    . plaquetas > 100 x 109 g/dl (100.000/µl);
    . hemoglobina > 10,0 g/dl.
    . Función hepática normal definida por:
    . bilirrubina total dentro de los límites institucionales normales;
    . aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT);
    < 2,5 × el límite superior de la normalidad (LSN);
    . las pacientes con bilirrubina sin conjugar elevada (síndrome de Gilbert) reunirán los requisitos si las enzimas y la función hepática están por lo demás dentro de los límites normales (es decir, AST, ALT y la fosfatasa alcalina están dentro de los límites normales), y no hay evidencia de hemólisis.
    . Función renal normal definida por creatinina < 1,5 × LSN o aclaramiento de creatinina estimado (CrCl) ? 50 ml/min calculado mediante el método Cockcroft-Gault
    . Las pacientes deben firmar un formulario de consentimiento informado aprobado por el CEIC antes de que se realice ningún procedimiento específico del estudio
    E.4Principal exclusion criteria
    Bilateral breast cancer

    Presence of known metastases

    Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer

    Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

    Pre-existing clinically significant (?grade 2) peripheral neuropathy

    Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension

    Severe dyspnea at rest requiring supplementary oxygen therapy

    History of positivity for hepatitis B surface antigen, hepatitis C virus, or HIV

    Recent infection requiring a course of systemic anti-infectives that were completed
    ?14 days before enrollment (with the exception of uncomplicated urinary tract infection)

    Woman of childbearing potential who is pregnant or is breast feeding

    Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) during treatment and for an additional 4 months after the last administration of the protocol specified treatment

    Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study

    Other investigational procedures while participating in this study are excluded

    Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients

    Subject previously has enrolled and/or has been randomized in this study

    Subject likely to not be available to complete all protocol required study visits or procedures

    History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
    . Cáncer de mama bilateral
    . Presencia de metástasis conocida
    . Tratamiento previo recibido, incluidos quimioterapia, terapia biológica, radiación o cirugía con la excepción de la biopsia diagnóstica de cáncer de mama primario
    . Otra neoplasia maligna activa concomitante o antecedentes de neoplasia maligna en los últimos 5 años salvo carcinoma de células basales de la piel tratado o carcinoma in situ del cuello uterino
    . Neuropatía periférica clínicamente significativa (? grado 2) preexistente
    . Cualquier antecedente de insuficiencia cardíaca congestiva actual, arritmias no controladas de alto riesgo actuales, angina de pecho actual que requiera un producto médico, valvulopatía clínicamente significativa actual, evidencia actual de infarto transparietal en electrocardiograma (ECG) o hipertensión actual deficientemente controlada
    . Disnea grave en reposo que requiera tratamiento con oxígeno complementario
    . Antecedentes de resultados positivos para el antígeno superficial de la hepatitis B, el virus de la hepatitis C o el VIH
    . Infección reciente que requiriese un curso completo de antiinfecciosos que se terminase ?14 días antes de la inscripción (con la excepción de infección urinaria no complicada)
    . Mujeres con capacidad para procrear que estén embarazadas o amamantando
    . Mujeres con capacidad para procrear que no acepten utilizar métodos anticonceptivos de alta eficacia (p. ej., abstinencia, esterilización, píldoras anticonceptivas, inyecciones de Depo-Provera o implantes anticonceptivos) durante el tratamiento y durante 4 meses adicionales después de la última administración del tratamiento especificado en el protocolo
    . Que reciban actualmente tratamiento en otro estudio de un fármaco o dispositivo en investigación, o menos de 30 días desde el fin del tratamiento con otro fármaco o dispositivo en investigación
    . Se excluyen otros procedimientos en investigación mientras participe en este estudio
    . Paciente que tenga sensibilidad conocida a cualquiera de los productos a administrar durante el estudio, incluidos productos farmacológicos derivados de células mamarias, trastuzumab, proteínas murinas o cualquiera de los excipientes
    . Paciente previamente inscrita y/o aleatorizada en este estudio
    . Paciente que probablemente no esté disponible para completar todos los procedimientos o visitas del estudio exigidas por el protocolo
    . Antecedentes o evidencia de cualquier otro trastorno, afección o enfermedad clínicamente significativos (con la excepción de aquellos descritos anteriormente) que, en opinión del investigador o médico de Amgen, si es consultado, pondría en riesgo la seguridad de la paciente o interferiría con la evaluación, procedimientos o finalización del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Risk ratio (RR) of the incidence of pathologic complete response (pCR) in breast tissue and axillary lymph nodes
    Coeficiente de riesgo (CR) de la incidencia de respuesta patológica completa (pCR) en el tejido mamario y los ganglios linfáticos axilares
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 10 (Initiation of investigational product adjuvant therapy cycle 1): Subjects will undergo a lumpectomy or mastectomy with sentinel node or axillary node dissection. Surgery is expected to be scheduled within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase and pCR will be analyzed.
    Visita 10 (inicio del ciclo 1 de tratamiento adyuvante del producto en investigación)
    Las pacientes se someterán a una mastectomía parcial o a una mastectomía total con disección del ganglio centinela o los ganglios axilares. Se espera que la cirugía se programe a lo largo de las 3 a 7 semanas después de la última dosis del producto en investigación en la fase neoadyuvante y la PCR sea analyzada.
    E.5.2Secondary end point(s)
    Risk ratio (RR) of pCR in breast tissue

    Risk ratio (RR) of pCR in breast tissue and axillary lymph nodes and absence of Ductal Carcinoma in Situ (DCIS)
    Coeficiente de riesgo (CR) de la PCR en el tejido de la mama.

    Coeficiente de riesgo (CR) de la PCR en tejido de la mama y los nodos linfáticos auxiliares y ausencia de Carcinoma Ductal in Situ (DCIS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 10 (Initiation of investigational product adjuvant therapy cycle 1): Subjects will undergo a lumpectomy or mastectomy with SN or axillary node dissection. Surgery is expected to be scheduled within 3 to 7 weeks after the last dose of investigational product in the neoadjuvant phase Pathology of tumor sample and pCR will then be analyzed.
    Visita 10 (inicio del ciclo 1 de tratamiento adyuvante del producto en investigación)
    Las pacientes se someterán a una mastectomía parcial o a una mastectomía total con disección del ganglio centinela o los ganglios axilares. Se espera que la cirugía se programe a lo largo de las 3 a 7 semanas después de la última dosis del producto en investigación en la fase neoadyuvante y la PCR sea analyzada.
    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 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
    ADA - anti-drug antibody testing is being performed
    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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Belarus
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Germany
    Greece
    Hungary
    Italy
    Mexico
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Ukraine
    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
    The end of study (end of trial) will be the date when the last subject has their last study assessment
    El final del estudio (fin del ensayo) será la fecha en que la última paciente reciba su última evaluación del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 445
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 111
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 355
    F.4.2.2In the whole clinical trial 556
    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)
    None
    Ninguno
    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 Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
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