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    Summary
    EudraCT Number:2015-001633-24
    Sponsor's Protocol Code Number:D419BC00001
    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:2015-11-23
    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 number2015-001633-24
    A.3Full title of the trial
    A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Bladder Cancer
    Ensayo fase III, aleatorizado, abierto, controlado, multicéntrico,
    internacional, de MEDI4736 en monoterapia y MEDI4736 en combinación
    con tremelimumab frente a tratamiento de referencia con quimioterapia
    como primera línea en pacientes con cáncer de vejiga urotelial irresecable en estadio IV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of First Line MEDI4736 with or without Tremelimumab versus Standard of Care Chemotherapy in Advanced Unresectable Urothelial Bladder Cancer
    Estudio de MEDI4736 en monoterapia y MEDI4736 en combinación
    con tremelimumab frente a tratamiento de referencia con quimioterapia
    como primera línea en pacientes con cáncer de vejiga urotelial irresecable.
    A.4.1Sponsor's protocol code numberD419BC00001
    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 supportAstraZenenca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number900200444
    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 nameMEDI4736
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form 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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderActivis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 2
    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.2.1.1.1Trade name Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCisplatin
    D.3.4Pharmaceutical form 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 INNCISPLATIN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCarboplatin
    D.3.4Pharmaceutical form 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 INNCARBOPLATIN
    D.3.9.2Current sponsor code41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 5
    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 nameTremelimumab
    D.3.2Product code MEDI1123
    D.3.4Pharmaceutical form 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 INNTremelimumab
    D.3.9.1CAS number 745013-19-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.9.3Other descriptive nameMEDI1123
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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
    Adult patients (age > o = 18 years) with histologically or cytologically documented transitional cell carcinoma (transitional cell and mixed transitional/non transitional cell histologies) of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra), unresectable Stage IV (ie, ?T4bN0M0 for bladder), and who are chemotherapy-naïve.
    Pacientes adultos (edad > o = 18 años) con carcinoma de células transicionales (histologías de células transicionales o mixtas de células transicionales/no transicionales) documentado histológicamente o citológicamente, irresecable, en estadio IV (esto es, T4b, cualquier N; o
    cualquier T, N2-N3; o M1) del urotelio (incluidos la pelvis renal, los uréteres, la vejiga urinaria y la uretra), que no han sido tratados previamente con quimioterapia de primera línea.
    E.1.1.1Medical condition in easily understood language
    Urothelial Bladder Cancer
    Cáncer de vejiga
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10022880
    E.1.2Term Invasive bladder cancer stage IV
    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 assess PFS of MEDI4736 in combination with tremelimumab to standard of care (SoC) chemotherapy
    Evaluar la eficacia del tratamiento de combinación de MEDI4736 + tremelimumab en comparación con el TdR en términos de
    SLP en pacientes con CVU
    E.2.2Secondary objectives of the trial
    1, To assess PFS of MEDI4736+tremelimumab to SoC chemotherapy, and to monotherapy in patients with PD-L1-negative. 2, To assess OS of MEDI4736 + tremelimumab to SoC chemotherapy. 3, To assess PFS of MEDI4736 monotherapy to SoC chemotherapy. 4. To further assess ORR of MEDI4736 + tremelimumab to SoC chemotherapy. 5, To assess disease-related symptoms in terms of FACT-BL. 6, To assess the PK of MEDI4736 monotherapy and MEDI4736 + tremelimumab. 7, To investigate the immunogenicity of monotherapy and MEDI4736+tremelimumab. 8, To assess the safety and tolerability in terms of AEs.
    1. Evaluar la eficacia del tto. de combinación de MEDI4736 + treme. en comparación con MEDI4736 en monot. en términos de SLP en pac. con CVU negativo para PD-L1
    2. Evaluar la eficacia del tto. de comb. de MEDI4736 + treme. en comp. con el TdR en términos de SG en pac. con CVU.
    3. Evaluar la eficacia de MEDI4736 en monot. en comp. con el TdR en términos de SLP en pacientes con CVU
    4. Evaluar la eficacia de MEDI4736 en monot. en comp. con el TdR en términos de SLP en pac. con CVU.
    5. Evaluar los síntomas relacionados con la enf. y la CdVRS en pac. con CVU tratados con MEDI4736 en monot.a y con tto. de comb. de MEDI4736 + treme. en comp. con el TdR y entre sí usando el cuestionario FACT-BL
    6. Evaluar la FC de MEDI4736 en monot. y el tto. de comb. de MEDI4736 + treme.
    7. Investigar la inmunog. de MEDI4736 en monot. y del tto. de comb. de MEDI4736 + treme.
    8. Evaluar el perfil de seg.y tolerab. de MEDI4736 en monot. y del tto. de comb. de MEDI4736 + treme. en comparación con el TdR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1, Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
    2, Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: ? Creatinine clearance (calculated or measured) <60 mL/min ? Common Terminology Criteria for Adverse Events (CTCAE) Grade ?2 audiometric hearing loss ? CTCAE Grade 2 peripheral neuropathy ? New York Heart Association Class III heart failure.
    3, Tumor PD-L1 status, with IHC assay confirmed by a reference laboratory, must be known prior to randomization.
    1. Pacientes con carcinoma de células transicionales (histologías de células transicionales y mixta de células transicionales/no transicionales) documentado histológicamente o citológicamente, irresecable, en estadio IV del urotelio, que no han recibido tratamiento previo con quimioterapia de primera línea.
    2. Pacientes elegibles o inelegibles para quimioterapia basada en cisplatino. La inelegibilidad para el cisplatino se define como el cumplimiento de 1 de los criterios siguientes: - Aclaramiento de creatinina (calculado o medido) <60 ml/min. - Pérdida auditiva audiométrica de grado > o =2 de los Criterios de Terminología
    Común para Acontecimientos Adversos (CTCAE).
    - Neuropatía periférica de grado 2 de los CTCAE. - Insuficiencia cardíaca de clase III de la New York Heart Association.
    3. Debe conocerse el estado de PD-L1 en el tumor, con ensayo de IHQ confirmado por un laboratorio de referencia, antes de la aleatorización.
    E.4Principal exclusion criteria
    1, Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA 4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines.
    2, History of allogenic organ transplantation that requires use of immunosuppressive agents.
    3, Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: ? Patients with vitiligo or alopecia ? Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement of psoriasis not requiring systemic treatment.
    4, Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have a CT/ MRI of the brain prior to study entry.
    5, Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
    6, Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736 or tremelimumab. The following are exceptions to this criterion: ? Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection), ? Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent, ? Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
    7, Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.
    1. Exposición previa a tratamiento mediado por el sistema inmunitario (a excepción del bacilo de Calmette Guerin, BCG), incluidos, entre otros, anticuerpos anti-CTLA-4, anti-PD-1, anti-PD-L1 o anti-PD-L2 y vacunas oncológicas terapéuticas.
    2. Antecedentes de trasplante alogénico de órganos que requiere el uso de agentes inmunosupresores.
    3. Trastornos autoinmunitarios o inflamatorios documentados, activos o previos dentro de los 3 últimos años antes del comienzo del tratamiento. Lo siguiente son excepciones a este criterio:
    - Pacientes con vitíligo o alopecia.
    - Pacientes con hipotiroidismo (p. ej., posterior a síndrome de Hashimoto) estable con sustitución hormonal o psoriasis que no precise tratamiento sistémico.
    4. Metástasis cerebrales o compresión de la médula espinal. Los pacientes con sospecha de metástasis cerebrales en la selección deben someterse a TC/RM del cerebro antes de la entrada en el ensayo.
    5. Infección activa, incluidas infección por hepatitis B, hepatitis C o el virus de la inmunodeficiencia humana (VIH).
    6. Uso actual o previo de medicamentos inmunosupresores dentro de los 14 días previos a la primera dosis de MEDI4736 o tremelimumab. Lo siguiente son excepciones a este criterio:
    - Esteroides intranasales, inhalados o tópicos o inyecciones locales de esteroides (p. ej., inyección intraarticular)
    - Corticosteroides sistémicos a dosis fisiológicas que no superen los 10 mg/día de prednisona o su equivalente
    - Esteroides como premedicación para reacciones de hipersensibilidad (p. ej., premedicación para TC)
    7. Recepción de una vacuna atenuada viva dentro de los 30 días previos a la primera dosis del PI. Nota: los pacientes, si son reclutados, no deben recibir vacunas vivas durante el ensayo y hasta 30 días después de la última dosis del PI.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 3 years
    Hasta los 3 años
    E.5.2Secondary end point(s)
    1, Overall survival. 2, OS24. 3, Proportion of patients alive and progression-free at 12 months. 4, Objective response rate. 5, Duration of response. 6, Disease control rate. 7, Best objective response.
    1. Supervivencia global
    2.SG24
    3. Proporción de pacientes vivos y libres de progresión a los 12 meses desde la aleatorización
    4. Tasa de respuesta objetiva
    5. Duración de la respuesta
    6. Tasa de control de la enfermedad
    7. Mejor respuesta objetiva
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to the end of treatment
    Desde el incio hasta el final del tratamiento.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Brazil
    Canada
    Denmark
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente.
    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 months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days14
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 239
    F.4.2.2In the whole clinical trial 525
    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)
    After end of treatment with study drug, patients should be managed according to local standard of care.
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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