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    Summary
    EudraCT Number:2012-003649-14
    Sponsor's Protocol Code Number:BAY73-4506/15982
    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:2013-03-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-003649-14
    A.3Full title of the trial
    A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib
    Estudio aleatorizado, doble ciego, controlado con placebo y multicéntrico de fase III con Regorafenib en pacientes con carcinoma hepatocelular (CHC) después de Sorafenib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This clinical study evaluates the efficacy and safety of regorafenib in patients with advanced liver cancer who have progressed on sorafenib treatment.
    Este ensayo clinico evalua la eficacia y la seguridad de regorafenib en pacientes con CHC cuya enfermedad ha progresado después de recibir sorafenib.
    A.4.1Sponsor's protocol code numberBAY73-4506/15982
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointClinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref 'EU CTR'/Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 Stivarga
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare Pharmaceuticals 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 nameRegorafenib
    D.3.2Product code BAY 73-4506
    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 INNRegorafenib
    D.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor codeBAY 73-4506
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Hepatocellular carcinoma (HCC)
    Carcinoma hepatocelular (CHC)
    E.1.1.1Medical condition in easily understood language
    Liver Cancer
    Cancer hepático
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10019829
    E.1.2Term Hepatocellular carcinoma recurrent
    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
    The objective of this study is to evaluate efficacy and safety of regorafenib in patients with HCC who have progressed after sorafenib
    El objetivo de este estudio es evaluar la eficacia y la seguridad de regorafenib en pacientes con CHC cuya enfermedad ha progresado después de recibir sorafenib.
    E.2.2Secondary objectives of the trial
    None
    Ninguno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent (IC) obtained before any study specific procedure. Patients must be able to understand and willing to sign the written informed consent.
    - Male or female patients >= 18 years of age.
    - Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria in patients with a confirmed diagnosis of cirrhosis.
    - Barcelona Clinic Liver Cancer (BCLC) stage Category B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
    - Failure to prior treatment with sorafenib (defined as documented radiological progression according to the radiology charter). Randomization needs to be performed within 8 weeks after the last treatment with sorafenib.
    - Tolerability of prior treatment with sorafenib defined as not less than 20 days at a minimum daily dose of 400 mg QD within the last 28 days prior to withdrawal.
    - Liver function status Child-Pugh Class A. Child Pugh status should be calculated based on clinical findings and laboratory results during the screening period.
    - Local or loco-regional therapy (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed >= 4 weeks before first dose of study medication.
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    - Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted within 7 days before randomization:
    o Hemoglobin > 8.5 g/dl
    o Absolute neutrophil count (ANC) >= 1500/mm3
    o Platelet count >= 60.000/mm3
    o Total bilirubin <= 2 mg/dl. Mildly elevated total bilirubin (<6 mg/dL) is allowed if Gilbert's syndrome is documented.
    o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 5 x upper limit of normal (ULN)
    o Prothrombin time-international normalized ratio (PT-INR) < 2.3 x (ULN). Patients who are therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in this parameter exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement that is pre-dose as defined by the local standard of care.
    o Serum creatinine <= 1.5 x ULN
    o Amylase and lipase <= 2 x ULN
    - Glomerular filtration rate (GFR) >= 30 ml/min/1.73 m2 according to the Modification of diet in renal disease (MDRD) abbreviated formula
    - At least one naïve (not previously treated by locoregional therapy such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) uni-dimensional measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST (RECIST version 1.1), and modified RECIST for HCC.
    - Life expectancy of at least 3 months.
    - Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until at least 3 months for men and 12 months for woman after the last study drug administration. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care.
    - Consentimiento informado (CI) firmado, obtenido antes de efectuar cualquier procedimiento específico del estudio. Los pacientes deben poder comprender el consentimiento informado por escrito y estar dispuestos a firmarlo.
    - Hombres o mujeres >=18 años.
    - Confirmación histológica o citológica del CHC o diagnóstico no invasivo de CHC según los criterios de la Asociación Americana para el Estudio de Hepatopatías (American Association for the Study of Liver Diseases, AASLD) (véase la Sección 14.7) en pacientes con diagnóstico confirmado de cirrosis.
    - Estadio Categoría B o C según el grupo de oncología hepática Barcelona Clinic Liver Cancer, (BCLC), que no puede beneficiarse con tratamientos de eficacia establecida de mayor prioridad, como resección, trasplante de hígado, ablación local, quimioembolización o sorafenib sistémico.
    - Fracaso de un tratamiento previo con sorafenib (definido como progresión radiológica documentada de acuerdo con los estatutos de radiología). La aleatorización debe efectuarse en la 8 semanas posteriores al último tratamiento con sorafenib.
    - Tolerabilidad al tratamiento previo con sorafenib, definida como no menos de 20 días con una dosis diaria mínima de 400 mg, en los últimos 28 días previos a la interrupción.
    - Nivel funcional hepático de Clase A según Child-Pugh. La clasificación de Child Pugh debe calcularse según los hallazgos clínicos y los resultados analíticos durante el período de selección.
    - Los tratamientos locales o locoregionales (p. ej., cirugía, radioterapia, embolización de la arteria hepática, quimioembolización, ablación por radiofrecuencia, inyección percutánea de etanol o crioablación) deben haber finalizado >=4 semanas antes de la primera dosis del medicamento del estudio.
    - Escala del estado funcional del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG) 0 o 1.
    - Función de la médula ósea, hepática y renal adecuadas, evaluadas mediante los siguientes análisis de laboratorio, efectuados en los 7 días anteriores a la aleatorización:
    o Hemoglobina >8,5 g/dl
    o Neutrófilos, recuento absoluto (ANC) >=1500/mm3
    o Recuento de plaquetas >=60.000/mm3
    o Bilirrubina total <=2 mg/dl. Se permite una elevación leve de la bilirrubina (<6 mg/dl) si hay un síndrome de Gilbert documentado.
    o Alanino aminotransferasa (ALT) y aspartato amino transferasa (AST) <= 5 veces el límite superior de lo normal (LSN)
    oÍndice internacional normalizado de tiempo de protrombina (PT-INR) < 2,3 veces el LSN o TP <6 segundos superior a los controles. Se permitirá participar a los pacientes que estén anticoagulados terapéuticamente con agentes como warfarina o heparina, siempre y cuando no haya pruebas anteriores de una anomalía subyacente de este parámetro. Se efectuará una monitorización estrecha, con evaluaciones por lo menos semanales, hasta que el INR se estabilice, según una determinación anterior a la dosis, como lo defina la pauta de atención local.
    o Creatinina sérica <=1,5 veces el LSN
    o Amilasa y lipasa <=2 veces el LSN
    - Tasa de filtración glomerular (TFG) >=30 ml/min/1,73 m2 de acuerdo con la fórmula abreviada de la Modificación de la dieta en las enfermedades renales (MDRD). Véase la Sección 14.11.
    - Al menos una lesión ?nueva? (no sometida previamente a tratamientos locoregionales como cirugía, radioterapia, embolización de la arteria hepática, quimioembolización, ablación por radiofrecuencia, inyección percutánea de etanol o crioablación) unidimensional medible por tomografía computarizada (TC) o resonancia magnética (RM) según criterios RECIST (RECIST v 1.1) y RECIST modificados para CHC.
    - Expectativa de vida mínima de 3 meses.
    - Las mujeres que puedan tener hijos y los hombres deben aceptar el uso de métodos anticonceptivos adecuados desde el momento de la firma del formulario de consentimiento informado (FCI) hasta por lo menos 3 meses después de la última administración del medicamento del estudio, en el caso de los hombres, y hasta 12 meses después en el caso de las mujeres. El investigador o un colaborador que él designe deberán asesorar al paciente sobre cómo lograr un control adecuado de la natalidad. En el estudio, la anticoncepción adecuada se define como cualquier método recomendado médicamente (o una combinación de métodos) según la pauta estándar de atención.
    E.4Principal exclusion criteria
    - Prior liver transplantation or candidates for liver transplantation
    - Prior treatment with regorafenib. Patients permanently withdrawn from study participation will not be allowed to re-enter the study.
    - Prior and/or concomitant participation in a clinical study other than with sorafenib during or within 4 weeks of randomization.
    - Sorafenib treatment within 2 weeks of randomization.
    - Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of esophageal varices should be performed by endoscopy within 6 months of study start, and within 12 months for patients in whom conventional medical intervention for known esophageal varices is already in place.
    - Prior systemic treatment for HCC, except sorafenib.
    - Permanent discontinuation of prior sorafenib therapy due to sorafenib related toxicity.
    - Permanent discontinuation of prior sorafenib therapy due to any cause more than 8 weeks prior to randomization.
    - Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or basal cell epithelioma. Any cancer curatively treated > 3 years prior to study entry is permitted.
    - Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
    - Major surgical procedure or significant traumatic injury within 28 days before randomization.
    - Congestive heart failure New York Heart Association (NYHA) >= class 2
    - Unstable angina (angina symptoms at rest, new-onset angina i.e., within the last 3 months) or myocardial infarction (MI) within the past 6 months before randomization.
    - Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    - Uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
    - Patients with phaeochromocytoma.
    - Uncontrolled ascites (defined as not easily controlled with diuretic or paracentesis treatment).
    - Pleural effusion or ascites that causes respiratory compromise (NCI-CTCAE version 4.0 Grade >= 2 dyspnea).
    - Persistent proteinuria of NCI-CTCAE version 4.0 Grade 3 or higher. Urine dipstick result of 3+ is allowed if protein excretion (estimated by urine protein/creatinine ratio on a random urine sample) is < 3.5 g/24 hours.
    - Ongoing infection > Grade 2 according to NCI-CTCAE version 4.0. Hepatitis B and Hepatitis C are allowed if no active replication is present.
    - Clinically significant bleeding NCI-CTCAE version 4.0 Grade 3 or higher within 30 days before randomization.
    - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study medication.
    - Unresolved toxicity higher than NCI-CTCAE version 4.0 Grade 1 (excluding alopecia or anemia) attributed to any prior therapy/procedure.
    - Any illness or medical condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study.
    - Known history of human immunodeficiency virus (HIV) infection.
    - Seizure disorder requiring medication.
    - History or organ allograft.
    - Non-healing wound, ulcer, or bone fracture.
    - Renal failure requiring hemo-or peritoneal dialysis.
    - Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results.
    - Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    - Patients unable to swallow oral medications.
    - Interstitial lung disease with ongoing signs and symptoms at the time of screening.
    - Any malabsorption condition.
    - Breast feeding
    - Pregnancy
    - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site that would have access to study records and electronic case report form (eCRF) data).
    - Trasplante anterior de hígado o candidatos para trasplante de hígado
    - Tratamento previo con regorafenib. No se permitirá que los ptes retirados definitivamente de participar en el estudio entren nuevamente al estudio.
    - Participación anterior y/o simultánea en un estudio clínico que no sea con sorafenib durante o en las 4 semanas de la aleatorización.
    - Tratamiento con sorafenib en las 2 semanas de la aleatorización.
    - Pacientes con varices esofágicas de gran tamaño y con riesgo de hemorragia que no hayan sido tratados mediante una intervención médica convencional: betabloqueantes o tratamiento endoscópico. La evaluación de las várices esofágicas debe hacerse por endoscopia en los 6 meses siguientes del comienzo del estudio y en los 12 meses siguientes en el caso de los ptes que ya hayan recibido una intervención médica convencional para las várices esofágicas conocidas.
    - Tratamiento anterior sistémico para el CHC, excepto sorafenib
    - Interrupción definitiva del tratamiento anterior con sorafenib debido a su toxicidad.
    - Interrupción definitiva del tratamiento anterior con sorafenib por cualquier causa, más de 8 semanas antes de la aleatorización.
    - Antecedentes o historial actual de neoplasias diferentes al CHC, excepto el carcinoma in situ de cuello uterino y/o el epitelioma basocelular. Se permite cualquier cáncer tratado curativamente >3 años antes de la entrada al estudio.
    - Antecedentes conocidos de metástasis cerebrales sintomáticas o de tumores meníngeos (efectuar una TC o RM craneal en la selección para confirmar la ausencia de enfermedad en el sistema nervioso central [SNC] si el paciente presenta síntomas que sugieren o son compatibles con enfermedad del SNC).
    - Intervención quirúrgica mayor o lesión traumática importante en los 28 días anteriores a la aleatorización.
    - Insuficiencia cardíaca congestiva la Asociación Cardiaca de Nueva York (New York Heart Association, NYHA) >= clase 2.
    - Angina inestable (síntomas anginosos en reposo, angina de aparición reciente, es decir en los últimos 3 meses) o infarto de miocardio (IM) en los 6 meses anteriores a la aleatorización.
    - Arritmias cardíacas que requieran tratamiento antiarrítmico (se permiten los betabloqueantes o la digoxina).
    - Hipertensión no controlada (tensión arterial [TA] sistólica >150 mmHg o diastólica >90 mmHg a pesar de un tratamiento médico óptimo).
    - Ptes con feocromocitoma.
    - Ascitis no controlada (definida como de difícil control con diuréticos o paracentesis).
    - Derrame pleural o ascitis que produce compromiso respiratorio (disnea de grado >= 2 según los Criterios Terminológicos Comunes para Acontecimientos Adversos [Common Terminology Criteria for Adverse Events, CTCAE] del Instituto Nacional del Cáncer [National Cancer Institute, NCI], versión 4.0).
    - Proteinuria persistente de grado 3 o superior según los CTCAE del NCI, versión 4.0. Se permite un resultado de 3+ mediante tira reactiva en orina si la excreción de proteínas (calculada por el cociente proteínas/creatinina en orina en una muestra de orina tomada al azar) es <3,5 g/24 horas
    - Infección de grado >2 en curso, según los CTCAE del NCI, versión 4.0. Se permiten la hepatitis B y C si no hay replicación activa.
    - Hemorragia clínicamente significativa de grado 3 o superior según los CTCAE del NCI, versión 4.0, en los 30 días anteriores a la aleatorización.
    - Acontecimientos trombóticos o embólicos, arteriales o venosos, tales como accidente cerebrovascular (ataques isquémicos transitorios incluidos), trombosis venosa profunda o embolia pulmonar en los 6 meses anteriores a comenzar el medicamento del estudio.
    - Toxicidad no resuelta de grado superior a 1 según los CTCAE del NCI, versión 4.0 (excepto alopecia y anemia) atribuible a cualquier tratamiento o procedimiento previo.
    - Cualquier enfermedad o problema médico inestable o q podría amenazar la seguridad dl pte y/o su cumplimiento terapéutico durante el estudio.
    - Antecedentes conocidos d infección con el virus d la inmunodeficiencia humana (VIH).
    - Trastorno convulsivo q requiera medicamentos.
    - Antecedentes d aloinjerto d órganos.
    - Heridas, úlceras o fracturas que no cicatrizan.
    - Insuficiencia renal que requiere hemodiálisis o diálisis peritoneal.
    - Drogadicción, problemas médicos, psicológicos o sociales q puedan interferir con la participación dl pte en el estudio o con la evaluación d los resultados dl estudio.
    - Hipersensibilidad conocida a cualquiera d los medicamentos dl estudio, a las clases dl medicamento dl estudio o a los excipientes d su formulación.
    - Ptes incapaces d tomar medicamentos x vía oral.
    - Enfermedad intersticial pulmonar con signos y síntomas en curso en el momento de selección.
    - Cualquier problema de malabsorción.
    - Período d lactancia.
    - Embarazo.
    - Relación cercana con el centro d investigación; p. ej., familiar cercano dl investigador, dependiente (p. ej., empleado o estudiante dl centro de investigación que podría tener acceso a los registros dl estudio y a los datos d los CRDe).
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS)
    Supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time (days) from date of first dose of study medication to death due to any cause
    El tiempo (días) desde la fecha de la primera dosis de la medicación de estudio hasta la muerte por cualquier causa
    E.5.2Secondary end point(s)
    - Time to progression (TTP)
    - Progression free survival (PFS)
    - Objective tumor response rate (ORR)
    - Disease control rate (DCR = CR + PR + SD)
    - Tiempo transcurrido hasta la progresión (TTP)
    - Supervivencia sin progresión (SSP)
    - Tasa de respuesta objetiva (TRO) del tumor
    - Tasa de control de la enfermedad (TCE = RC + RP + EE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 33 months
    Aproximadamente 33 meses
    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 No
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    Singapore
    Spain
    Switzerland
    Taiwan
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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: 265
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 265
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 530
    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
    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 Decision2013-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-05
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