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    Summary
    EudraCT Number:2015-000575-27
    Sponsor's Protocol Code Number:MK-3475-091
    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:2015-07-31
    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 number2015-000575-27
    A.3Full title of the trial
    A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS)
    Ensayo de fase III, aleatorizado, con el anticuerpo monoclonal anti-PD-1 pembrolizumab (MK-3475) en comparación con placebo en pacientes con CPNM en estadios iniciales tras la resección y la finalización del tratamiento adyuvante de referencia (PEARLS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapeutic treatment with Pembrolizumab (antibody) in patients with early stage non-small cell lung cancer
    Tratamiento inmunoterápico con Pembrolizumab (anticuerpo) en pacientes en estadios iniciales de cáncer pulmonar no microcítico
    A.3.2Name or abbreviated title of the trial where available
    PEARLS
    A.4.1Sponsor's protocol code numberMK-3475-091
    A.5.4Other Identifiers
    Name:EORTCNumber:1416-LCG
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 Yes
    D.2.1.1.1Trade name Keytruda®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namepembrolizumab
    D.3.2Product code MK-3475; SCH900475
    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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage IB (T >= 4 cm), II and IIIA NSCLC
    CPNM en estadio IB (T >= 4 cm), II y IIIA
    E.1.1.1Medical condition in easily understood language
    Early stage non small cell lung cancer after resection
    Estadios iniciales de cáncer pulmonar no microcítico tras la resección quirúrgica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (lobectomy/pneumonectomy) with or without standard adjuvant chemotherapy for stage IB (T >= 4 cm) -II-IIIA NSCLC patients improves Disease Free Survival (DFS), as assessed locally by the investigator, compared to placebo in the PD-L1 strong positive subgroup and overall population.
    Investigar de forma prospectiva si el tratamiento adyuvante con pembrolizumab posterior a una cirugía radical (lobectomía/neumonectomía) con o sin quimioterapia adyuvante de referencia en pacientes con carcinoma pulmonar no microcítico (CPNM) en estadio IB (T >= 4 cm), II y IIIA mejora la supervivencia libre de enfermedad (SLE), según la evaluación local del investigador, en comparación con el placebo en el subgrupo que presente un resultado positivo intenso para PD-L1 y en la población general.
    E.2.2Secondary objectives of the trial
    - To prospectively compare DFS as assessed by the investigator in the PD-L1 positive population;
    - To prospectively determine and compare OS in the PD-L1 strong positive and overall population;
    - To prospectively determine and compare OS in the PD-L1 positive population;
    - To prospectively determine and compare the Lung Cancer Specific Survival (LCSS) in the whole population irrespective of PD-L1 expression status;
    - To prospectively assess the safety of pembrolizumab after radical surgery followed by standard adjuvant chemotherapy.
    -Comparar de forma prospectiva la SLE según la evaluación del investigador en la población con resultado positivo para PD-L1
    -De forma prospectiva, determinar y comparar la SG en la población con resultado positivo intenso para PD-L1 y en la población en general;
    -De forma prospectiva, determinar y comparar la SG en la población con resultado positivo para PD-L1;
    -De forma prospectiva, determinar y comparar la supervivencia específica para el cáncer de pulmón (SECP) en toda la población, con independencia del estado de expresión del ligando PD-L1;
    -De forma prospectiva, evaluar la seguridad del pembrolizumab tras la cirugía radical seguida de quimioterapia adyuvante de referencia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pathological diagnosis of NSCLC confirmed at surgery, any histology is eligible;
    - UICC v7 stage IB (T >= 4 cm), II-IIIA NSCLC at complete surgical resection with no residual disease (R0) after complete surgical resection (lobectomy/pneumonectomy)
    - Availability of tumor sample obtained at surgical resection for PD-L1 Immunohistochemistry (IHC) expression assessment.
    - At least 18 years;
    - Written informed consent must be given according to ICH/GCP, and national/local regulations;
    - Adjuvant chemotherapy is not mandatory but considered for patients with stage IB (T >= 4 cm) and strongly recommended for stage II and IIIA, and will be administered according to national and local guidelines. Patients who received more than 4 cycles of adjuvant therapy are not eligible;
    - ECOG Performance status 0-1;
    - Adequate organ function performed within 10 days of treatment initiation;
    - Female patients must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study medication) irrespectively of their childbearing potential;
    - If of childbearing potential, female patients must be willing to use two adequate barrier methods throughout the study, starting with the screening visit up to 120 days after last dose of chemotherapeutic and investigational agents as specified in the protocol;
    - Male patients with a female partner(s) of child-bearing potential must agree to use two adequate barrier methods throughout the trial starting with the screening visit through 120 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
    - Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 44 months after the last study treatment;
    - Absence of severe comorbidities that in the opinion of the Investigator might hamper the participation to the study and/or the treatment administration;
    -Diagnóstico patológico de CPNM confirmado en la intervención quirúrgica; cualquier prueba histológica es apta
    -CPNM en estadio IB (T ? 4 cm), II-IIIA según la v7 de la clasificación de la UICC en el momento de la resección quirúrgica completa sin enfermedad residual (R0) tras resección quirúrgica completa (lobectomía/neumonectomía)

    -Disponibilidad de muestra tumoral obtenida en la resección quirúrgica para la realización de una evaluación de la expresión del PD-L1 mediante inmunohistoquímica (IHQ).

    -18 años de edad como mínimo
    -El paciente deberá otorgar su consentimiento informado por escrito conforme a las BPC de la ICH y a la legislación nacional/local;
    -La quimioterapia adyuvante no es obligatoria pero se tendrá en cuenta para los pacientes en estadio IB (T ? 4 cm), se recomienda de forma especial para los pacientes en estadios II y IIIA y se administrará conforme a las directrices nacionales y locales. No obstante, los pacientes que hayan recibido más de 4 ciclos de tratamiento adyuvante no podrán participar en el ensayo;
    -Estado funcional 0 a 1 de la ECOG;
    -Función orgánica adecuada en los 10 días previos al comienzo del tratamiento
    -En el momento de la selección, las pacientes deben presentar un resultado negativo en la prueba de embarazo en orina o en sangre (en las 72 horas anteriores a la primera dosis de la medicación del estudio) con independencia de su potencial fértil
    -En el caso de pacientes en edad fértil, deberán estar dispuestas a utilizar dos métodos anticonceptivos adecuados de barrera en el transcurso del estudio, a partir de la visita de selección hasta 120 días después de la última dosis de los fármacos quimioterapéuticos y experimentales según se especifica en el protocolo

    -Los pacientes masculinos con pareja en edad fértil, deberán estar dispuestos a utilizar dos métodos anticonceptivos adecuados de barrera en el transcurso del estudio, a partir de la visita de selección hasta 120 días después de la última dosis del tratamiento del estudio. Los varones con parejas gestantes deberán comprometerse a utilizar preservativo; no será necesario que la pareja gestante utilice un método anticonceptivo adicional.

    -Las mujeres en período de lactancia deberán interrumpirla antes de la primera dosis del tratamiento del estudio y hasta 44 meses después de la última dosis del fármaco del estudio;
    -Ausencia de comorbilidades severas o graves que, a juicio del investigador, puedan impedir la participación del paciente en el estudio o la administración del tratamiento
    E.4Principal exclusion criteria
    - Evidence of disease at clinical examination and/or baseline radiological assessment on baseline assessment as documented by contrast enhanced chest/upper abdomen CT scan, brain CT/MRI and clinical examination;
    - Prior or foreseen neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy;
    - Prior treatment with an anti-PD-1, anti-PD-L1/2, anti- CD137, CTLA-4 modulators; patients receiving live vaccine within 30 days prior to the first dose of study treatment are not eligible;
    - Current participation or treatment with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment;
    - Known history or current evidence of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive) or C (e.g., HCV RNA[qualitative] is detected) or Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies);
    - Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days prior to the first dose of trial treatment;
    - History of interstitial lung disease (ILD) OR pneumonitis (other than COPD exacerbation) that has required oral or IV steroids;
    - Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
    - History of a hematologic or primary solid tumor malignancy, unless in remission for at least 5 years. A pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanomatous skin cancer or carcinoma in situ of the cervix is eligible;
    - Previous allogeneic tissue/solid organ transplant;
    - Active infection requiring therapy;
    - Surgery or chemotherapy related toxicity (toxicity resolved to grade 1 (see Appendix D), with the exception of alopecia, fatigue, neuropathy and lack of appetite /nausea);
    - if the patient is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
    -Pruebas de la enfermedad (APE) en la exploración clínica y/o evaluación radiológica inicial en la evaluación del inicio del estudio según lo documentado en la TC torácica/abdominal superior mejorada por contraste, TC/RM encefálica y exploración clínica
    -Tratamiento anterior o previsto con radioterapia adyuvante o neoadyuvante o quimioterapia neoadyuvante;
    -Tratamiento anterior con moduladores anti-PD-1, anti-PD-L1/2, anti-CD137 y CTLA-4; los pacientes a los que se les haya administrado alguna vacuna con organismos vivos en un período de 30 días antes de la primera dosis del tratamiento del estudio no podrán participar en el ensayo
    - Participación en un ensayo o estén recibiendo tratamiento con un fármaco experimental o que hayan utilizado un dispositivo experimental en las 4 semanas anteriores a la primera dosis del tratamiento del estudio
    - Antecedentes o prueba actual de TB activa (bacilo tuberculoso), hepatitis B (por ejemplo, HBsAg reactivo) o C (por ejemplo, detección [cualitativa] de ARN del VHC) o virus de inmunodeficiencia humana (VIH) (anticuerpos del VIH 1/2)
    - Uso crónico de fármacos inmunosupresores o corticosteroides sistémicos o de cualquier uso durante los 3 días previos a la primera dosis del tratamiento del ensayo
    - Antecedentes de enfermedad pulmonar intersticial (EPI) O neumonía (salvo la reagudización de la EPOC) que haya requerido el uso de esteroides orales o i.v
    - Enfermedad autoinmunitaria activa que haya requerido tratamiento sistémico en los 2 últimos años (es decir, uso de fármacos modificadores de la enfermedad, corticosteroides o inmunosupresores). La terapia sustitutiva (es decir, tiroxina, insulina o terapia sustitutiva de corticosteroides fisiológicos para insuficiencia suprarrenal o pituitaria, etc.) no se considerará una forma de tratamiento sistémico y, por lo tanto, se permitirá.
    - Antecedentes de neoplasia hematológica o neoplasia sólida primaria, salvo que lleve en remisión como mínimo 5 años. En el ensayo podrán participar los pacientes con cáncer de próstata en estadio pT1-2 con una puntuación de Gleason < 6, cáncer vesical superficial, cáncer de piel no melanomatoso o carcinoma de cuello uterino in situ
    -Trasplante anterior de tejido alogénico/órgano sólido
    - Infección activa que requiera tratamiento
    -Toxicidad relacionada con la cirugía o la quimioterapia (toxicidad resuelta a grado 1 (consulte el Anexo D), con la excepción de alopecia, fatiga, neuropatía y falta de apetito/náuseas
    - si el paciente o algún familiar directo (p. ej. cónyuge, progenitor/tutor legal, hermano, hermana o hijo o hija) forma parte del personal del centro de investigación o del promotor y está implicado directamente en este ensayo, a menos que haya aprobación por parte del CEIC (a través de su presidente o persona delegada), en cuyo caso se haría una excepción de este criterio para un paciente en concreto.
    E.5 End points
    E.5.1Primary end point(s)
    1. DFS in the PD-L1 strong positive sub-group;
    2. DFS in the overall population (co-primary endpoint).
    1.SLE en el subgrupo con resultado positivo intenso para el ligando PD-L1;
    2.SLE en la población en general (criterio de valoración coprincipal).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Every 12 weeks (+- 2 weeks) during the 1st year after randomization, every 6 months for the 2nd and 3rd year, yearly up to the end of the 5th year
    2. Every 12 weeks (+- 2 weeks) during the 1st year after randomization, every 6 months for the 2nd and 3rd year, yearly up to the end of the 5th year
    1.Cada 12 semanas ( +- 2 semanas) durante el primer año tras aleatorización, cada 6 meses durante el segundo y tercer años, anualmente hasta fin del quinto año.
    2. Cada 12 semanas ( +- 2 semanas) durante el primer año tras aleatorización, cada 6 meses durante el segundo y tercer años, anualmente hasta fin del quinto año.
    E.5.2Secondary end point(s)
    1. DFS in the PD-L1 positive population;
    2. OS in the overall population;
    3. OS in the PD-L1 strong positive subgroup;
    4. OS in the PD-L1 positive population;
    5. LCSS in the overall population;
    6. Toxicity according to CTCAE version 4.0.
    1.SLE en la población con resultado positivo para el ligando PD-L1;
    2.SG en la población general;
    3.SG en el subgrupo con resultado positivo intenso para el ligando PD-L1;
    4.SG en la población con resultado positivo para el ligando PD-L1;
    5.SECP en la población general;
    6.Toxicidad según la versión 4.0 de los criterios CTCAE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Every 12 weeks (± 2 weeks) during the 1st year after randomization, every 6 months for the 2nd and 3rd year, yearly up to the end of the 5th year
    2. OS will be measured from the date of randomization until the date of death.
    3. OS will be measured from the date of randomization until the date of death.
    4. OS will be measured from the date of randomization until the date of death.
    5. LCSS will be measured from the date of randomization until the date of death (due to lung cancer specifically)
    6. Every 3 weeks during treatment and at 12 weeks after the last treatment
    1. Cada 12 semanas ( +- 2 semanas) durante el primer año tras aleatorización, cada 6 meses durante el segundo y tercer años, anualmente hasta fin del quinto año.
    2.SG se medirá desde fecha de la aleatorización a fecha de la muerte
    3. SG se medirá desde fecha de la aleatorización a fecha de la muerte
    4. SG se medirá desde fecha de la aleatorización a fecha de la muerte
    5. SECP se medirá desde fecha de la aleatorización hasta la fecha de muerte (debido al cáncer de pulmón concretamente)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Austria
    Belgium
    Denmark
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Netherlands
    Poland
    Portugal
    Slovenia
    Spain
    Sweden
    Switzerland
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. The trial is mature for the analysis of the primary/co-primary endpoints as defined in the protocol
    2. The database has been fully cleaned and frozen for this analysis
    Se considerará el fin del estudio cuando se cumplan todos los criterios siguientes:
    1. El ensayo esté maduro para proceder al análisis de los criterios principales/coprincipales de valoración tal y como se define en el protocolo.
    2. Se ha revisado y bloqueado completamente la base de datos de este análisis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months4
    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: 815
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 565
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1065
    F.4.2.2In the whole clinical trial 1380
    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)
    Study drug will not be provided after a patient ends his/her participation in the trial.
    No se proporcionará medicación del estudio una vez los pacientes hayan finalizado su participación en el mismo
    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 Decision2015-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-21
    P. End of Trial
    P.End of Trial StatusOngoing
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