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    Summary
    EudraCT Number:2013-000809-23
    Sponsor's Protocol Code Number:AB12003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2014-03-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2013-000809-23
    A.3Full title of the trial
    A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC)
    Estudio de fase III prospectivo, multicéntrico, randomizado, doble ciego, controlado con placebo y de 2 grupos paralelos para comparar la eficacia y seguridad de masitinib en combinación con docetaxel frente a placebo en combinación con docetaxel en el tratamiento de primera línea de pacientes con cáncer de próstata metastásico resistente a castración (mCPRC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate 2 types of treatment as first line treatment (masitinib + docetaxel or placebo + docetaxel ) in the treatment of patients with metastatic Castrate Resistant Prostate Cancer (mCRPC)
    Estudio para comparar la eficacia y seguridad de masitinib en combinación con docetaxel frente a placebo en combinación con docetaxel en el tratamiento de primera línea de pacientes con cáncer de próstata metastásico resistente a castración (mCPRC)
    A.4.1Sponsor's protocol code numberAB12003
    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 SponsorAB Science
    B.1.3.4CountryFrance
    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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointBeatrice Martin
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+331 40 70 14 99
    B.5.5Fax number+331 47 20 24 11
    B.5.6E-mailbeatrice.martin@ab-science.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 namemasitinib 100mg
    D.3.2Product code AB1010
    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 INNMasitinib mesylate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMASITINIB
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemasitinib 200mg
    D.3.2Product code AB1010
    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 INNMasitinib Mesylate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMASITINIB
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    metastatic Castrate Resistant Prostate Cancer (mCRPC).
    Cáncer de próstata metastásico resistente a castración
    E.1.1.1Medical condition in easily understood language
    metastatic Castrate Resistant Prostate Cancer (mCRPC).
    Cáncer de próstata metastásico resistente a castración (mCPRC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall survival (OS)
    Supervivencia global (SG)
    E.2.2Secondary objectives of the trial
    Secondary endpoint
    ? Survival rate every 6 months
    ? Overall Progression Free Survival (PFS)
    ? PFS rate every 12 weeks
    ? Overall Time To Progression (TTP)
    ? TTP rate every 12 weeks
    ? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
    ? Decline of PSA level ? 30% from baseline at time point
    ? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
    o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
    o Analgesic intake
    o ECOG Performance Status
    o Pain improvement (VAS)
    ? Pharmacogenomic assessment: Relationship between genomic data and overall survival.
    ? Safety profile using the NCI CTCAE v4.03 classification
    ? Tasa de supervivencia cada 6 meses
    ? Supervivencia global libre de progresión (SLP)
    ? Tasa de SLP cada 12 semanas
    ? Tiempo total hasta la progresión (TP)
    ? Tasa de TP cada 12 semanas
    ? Índice de mejor respuesta, índice de respuesta objetiva: respuesta completa (RC) o respuesta parcial (RP) y control de la enfermedad (RC+RP+EE) cada 12 semanas
    ? Disminución de los niveles de PSA ? 30% desde la visita basal en cada punto temporal
    ? Evaluación de la calidad de vida cada 6 semanas según el cuestionario EORTC QLQ-C30
    o Puntuación de la intensidad de dolor actual según el cuestionario del dolor de McGill-Melzack (MPQ)
    o Uso de analgésicos
    o Estado funcional ECOG
    o Mejoría del dolor (VAS)
    ? Evaluación farmacogenómica relación entre los datos genómicos y la supervivencia global.
    ? Perfil de seguridad según la clasificación NCI CTCAE v4.03.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    pharmacogenomic study: Relationship between genomic data and overall survival
    Evaluación farmacogenómica relación entre los datos genómicos y la supervivencia global.
    E.3Principal inclusion criteria
    1. Patient aged ≥ 18 years old, with histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:
    - Pre-treated with abiraterone with progressed disease documented, OR
    - with indication for initiating docetaxel administration (e.g., widespread visceral disease or rapidly progressive disease).

    2. Patient with evidence of progressive metastatic disease. Disease progression at trial enrolment is based on progression in at least one variable described in Table 5.
    3. Patient with ECOG ? 1
    4. Patient with adequate organ function:
    ? Absolute neutrophil count (ANC) ? 1.5 x 10ç/L
    ? Haemoglobin ? 10 g/dL
    ? Platelets (PTL) ? 75 x 109/L
    ? AST/ALT ? 3x ULN
    ? Gamma GT ?2.5 x ULN
    ? Bilirubin ? 1.5x ULN
    ? Normal creatinine or if abnormal creatinine, creatinine clearance ? 50 mL/min (Cockcroft and Gault formula)
    ? Albumin > 1 x LLN
    ? Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria ? 1+ on the dipstick, 24 hours proteinuria must be ? 1.5g/24h
    5. Patient with life expectancy > 6 months
    6. Patient with BMI > 18 and patient weight > 40 kg
    7. Man who agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for three months after the last treatment intake
    8. Patient able and willing to comply with study procedures as per protocol
    9. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent.
    10. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.
    1. Pacientes mayores de edad (≥ 18 años) con confirmación histológica o citológica de cáncer de próstata metastásico resistente a castración [castración médica o quirúrgica: privación de andrógenos con agonistas de GnHR o antagonistas o pacientes con castración quirúrgica; castración hormonal confirmada biológicamente (testosterona < 0.5 ng/ml)] con uno de los siguientes criterios:
    - Pre-tratados con abiraterona con progression de enfermedad documentada, O
    - Con indicación para iniciar la administración de docetaxel (e.j., enfermedad visceral generalizada o rápida progresión de enfermedad).

    2. Pacientes con evidencia de enfermedad metastásica progresiva. La progresión de la enfermedad en el reclutamiento del ensayo está basada en la progresión de como mínimo una variable de las descritas en la tabla 5.
    3. Pacientes con ECOG ? 1
    4. Pacientes con una actividad orgánica adecuada:
    ? Recuento absoluto de neutrófilos (RAN) ? 1,5 x 109/l
    ? Hemoglobina ? 10 g/dl
    ? Plaquetas (Plaq.) ? 75 x 109/l
    ? AST/ALT ? 3 x LSN
    ? Gamma GT ?2,5 x LSN
    ? Bilirrubina ? 1,5x x LSN
    ? Creatinina normal y, en caso de creatinina anómala, aclaramiento de creatinina ? 50 ml/min (fórmula de Cockcroft y Gault)
    ? Albúmina > 1 x LIN
    ? Proteinuria < 30 mg/dl (1+) en tira reactiva; si la proteinuria ? 1+ en tira reactiva, la proteinuria de 24 horas debe ser ? 1,5 g/24 horas
    5. Pacientes con una esperanza de vida > 6 meses
    6. Pacientes con un IMC > 18 y un peso > 40 kg
    7. Hombres que accedan a utilizar dos métodos anticonceptivos aceptados médicamente (uno para el paciente y el otro para la pareja) durante el estudio y en los tres meses posteriores a la última toma del tratamiento.
    8. Pacientes capaces y dispuestos a seguir los procedimientos del estudio según el protocolo.
    9. Pacientes capaces de entender, firmar y fechar el formulario de consentimiento informado en la visita de selección antes de que se lleve a cabo cualquier procedimiento específico del protocolo. Si el médico responsable considera que el paciente tiene un déficit cognitivo o dudoso que pueda cuestionar la capacidad del paciente para dar su consentimiento, deberá ser el tutor legal del paciente quien firme el consentimiento informado.
    10. Pacientes capaces de entender la tarjeta del paciente y dispuestos a seguir los procedimientos allí indicados en caso de observar signos o síntomas de neutropenia grave o toxicidad cutánea grave, durante los primeros 2 meses de tratamiento.
    E.4Principal exclusion criteria
    1. Patient who has been previously treated with chemotherapy.
    2. Patient with bone marrow irradiation > 40% within 12 months before baseline
    3. Patient treated for a cancer other than prostate cancer within 3 years before enrollment, with the exception of basal cell carcinoma (and pTa or pT1)
    4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
    5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
    ? Patient with recent cardiac history (within 6 months) of:
    o Acute coronary syndrome
    o Acute heart failure (class III or IV of the NYHA classification)
    o Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    ? Patient with cardiac failure class III or IV of the NYHA classification
    ? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    ? Syncope without known aetiology within 3 months
    ? Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension
    6. Patient with an history of poor compliance or an history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
    7. Patient under treatment with any anti-tumour therapy (any radiotherapy, chemotherapy, biologic or anti-androgen therapy except GnRH/LHRH analogs)
    1. Pacientes que hayan sido tratados previamente con quimioterapia.
    2. Pacientes que hayan recibido irradiación de médula ósea > 40% en los 12 meses anteriores a la visita basal.
    3. Pacientes tratados por algún otro cáncer distinto al cáncer de próstata en los 3 años anteriores al reclutamiento en este estudio, excepto por carcinoma de células basales (y pTa o pT1)
    4. Pacientes con metástasis activa en el sistema nervioso central (SNC) o con antecedentes de metástasis en el SNC.
    5. Pacientes con afecciones cardíacas definidas por, al menos, uno de los siguientes trastornos:
    ? Pacientes con antecedentes cardíacos recientes (en los 6 meses previos) de:
    o síndrome coronario agudo,
    o insuficiencia cardíaca aguda (clase III o IV según la clasificación de la NYHA),
    o arritmia ventricular significativa (taquicardia ventricular persistente, fibrilación ventricular, muerte súbita reanimada).
    ? Pacientes con insuficiencia cardíaca de clase III o IV según la clasificación de la NYHA.
    ? Pacientes con trastornos graves de la conducción cardíaca no evitables mediante electroestimulación cardíaca permanente (bloqueo auriculoventricular 2 y 3, bloqueo sinoauricular).
    ? Síncope de etiología desconocida en los 3 meses previos.
    ? Hipertensión grave no controlada, a juicio del investigador, o hipertensión sintomática.

    6. Pacientes con antecedentes de falta de cumplimiento terapéutico o drogadicción/alcoholismo, o consumo excesivo de bebidas alcohólicas o enfermedades psiquiátricas presentes o pasadas que pudieran interferir en la capacidad para cumplir el protocolo del estudio o para dar su consentimiento informado.
    7. Pacientes en tratamiento con cualquier antineoplásico (radioterapia, quimioterapia, fármacos biológicos o antiandrógenos a excepción de los análogos de la GnRH/LHRH).
    E.5 End points
    E.5.1Primary end point(s)
    ? Overall Survival (OS) is defined as the time from the randomization to the date of documented death
    ? La supervivencia global (SG) se define como el tiempo desde la fecha de la randomización hasta la fecha del fallecimiento documentado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of documented death
    Fecha del fallecimiento documentado.
    E.5.2Secondary end point(s)
    ? Survival rate every 6 months
    ? Overall Progression Free Survival (PFS)
    ? PFS rate every 12 weeks
    ? Overall Time To Progression (TTP)
    ? TTP rate every 12 weeks
    ? Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
    ? Decline of PSA level ? 30% from baseline at time point
    ? Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
    o Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
    o Analgesic intake
    o ECOG Performance Status
    o Pain improvement (VAS)
    ? Pharmacogenomic assessment: Relationship between genomic data and overall survival.
    ? Safety profile using the NCI CTCAE v4.03 classification
    ? Tasa de supervivencia cada 6 meses
    ? Supervivencia global libre de progresión (SLP)
    ? Tasa de SLP cada 12 semanas
    ? Tiempo total hasta la progresión (TP)
    ? Tasa de TP cada 12 semanas
    ? Índice de mejor respuesta, índice de respuesta objetiva: respuesta completa (RC) o respuesta parcial (RP) y control de la enfermedad (RC+RP+EE) cada 12 semanas
    ? Disminución de los niveles de PSA ? 30% desde la visita basal en cada punto temporal
    ? Evaluación de la calidad de vida cada 6 semanas según el cuestionario EORTC QLQ-C30
    o Puntuación de la intensidad de dolor actual según el cuestionario del dolor de McGill-Melzack (MPQ)
    o Uso de analgésicos
    o Estado funcional ECOG
    o Mejoría del dolor (VAS)
    ? Evaluación farmacogenómica relación entre los datos genómicos y la supervivencia global.
    ? Perfil de seguridad según la clasificación NCI CTCAE v4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 12 weeks
    Cada 12 semanas
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Austria
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    Greece
    Hong Kong
    Hungary
    India
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Morocco
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    South Africa
    Spain
    Tunisia
    Ukraine
    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
    patient treated until disease progression limiting toxicity or consent withdrawal. Follow-up performed until patient's death
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 550
    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 Decision2014-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusRestarted
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