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    Summary
    EudraCT Number:2010-019755-21
    Sponsor's Protocol Code Number:04-21
    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:2011-11-28
    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 number2010-019755-21
    A.3Full title of the trial
    A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na Administered as a 72-Hour Continuous Intravenous Infusion Every Other Week in Myelodysplastic Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine or Decitabine.
    Estudio de fase III, multicéntrico, aleatorizado y controlado para evaluar la eficacia y la seguridad de ON 01910.Na al administrarse mediante infusión intravenosa continua de 72 horas en semanas alternas a pacientes con síndrome mielodisplásico con exceso de blastocitos que presentan recurrencia tras el tratamiento con azacitidina o decitabina, o resistencia o intolerancia a dichos fármacos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of ON 01910.Na given by continuous intravenous infusion for 72 hours every other week in patients with a blood disease who have failed, or are resistant to, or intolerant to Azacitidine or Decitabine treatments.
    Estudio para evaluar la eficacia y seguridad de ON 01910.Na administrada por infusion intravenosa continua durante 72 horas todas las semanas en pacientes con enfermedad sanguinea que han fracasado, son resistente, o intolerantes a tratamientos con azacitidina o decitabina.
    A.4.1Sponsor's protocol code number04-21
    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 SponsorOnconova Therapeutics 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 supportLeukaemia and Lymphoma Society
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPRA- Pharmaceutical Research Associates
    B.5.2Functional name of contact pointOncology Support Centre
    B.5.3 Address:
    B.5.3.1Street AddressDynamostrasse 13-15
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post codeD-68165
    B.5.3.4CountryGermany
    B.5.4Telephone number+441792 52 5608
    B.5.5Fax number+49621 87 82 181
    B.5.6E-mailoncoeu@praintl.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 Yes
    D.2.5.1Orphan drug designation number09-2894
    D.3 Description of the IMP
    D.3.2Product code ON01910.Na
    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 INNN/A
    D.3.9.1CAS number 592542-60-1
    D.3.9.2Current sponsor codeON 01910.Na
    D.3.9.3Other descriptive nameSodium salt of (E)-2,4,6-trimethoxystyryl-3-carboxymethylamino-4-methoxybenzyl sulfone; sal de sodio de (E)-2,4,6-trimetoxistiril-3-carboximetilamino-4-metoxilbencilsulfato
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myelodysplastic syndrome with excess blasts
    Síndrome mielodisplásico con exceso de blastocitos
    E.1.1.1Medical condition in easily understood language
    Disease of the blood and bone marrow
    Enfermedad de la sangre y la médula ósea
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare overall survival (OS) in patients receiving 1800 mg/24 hr of ON 01910.Na via 72-hour continuous intravenous infusion administered every other week + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome with excess blasts (5% to 30% bone marrow blasts) having failed, being intolerant, or progressing after azacitidine or decitabine treatment.
    Objetivo principal: el objetivo principal del estudio es comparar la supervivencia general (SG) en los pacientes que reciben 1800 mg/24 h de ON 01910.Na por medio de infusión intravenosa continua durante 72 horas en semanas alternas y el mejor tratamiento sintomático o de soporte (BSC) con la SG de los pacientes que reciben BSC en una población de pacientes con síndrome mielodisplásico con exceso de blastocitos (del 5 % al 30 % de blastocitos en la médula ósea) en los que ha fallado el tratamiento con azacitidina o decitabina, que son intolerantes a él
    E.2.2Secondary objectives of the trial
    Compare the BSC + ON 01910.Na group to the BSC group with respect to:
    -Overall response (complete + partial remission) according to 2006 IWG criteria
    -Complete bone marrow response according to 2006 IWG criteria
    -Hematological improvements in absolute neutrophil count (ANC),
    platelet count, and erythroid responses according to 2006 IWG criteria
    -Improvements of cytogenetics as evaluated by the change in aneuploidy in bone marrow according to 2006 IWG criteria
    -Transition time to AML:
    Defined for RAEB-1 and RAEB-2 MDS and chronic myelomonocytic leukemia (CMML) patients (with BM blasts from 10% to 20% for CMML) by an increase of at least 50% BM blasts and more than 20% BM blasts
    Defined for RAEB-t by an increase of at least 50% BM blasts
    -Quality-of-life (QOL) scores (using the EORTC Quality of Life
    Questionnaire [QLQ]-C30 version 3
    -Incidence of infections
    Comparar grupo BSC + ON 01910.Na con grupo BSC en relación a:
    -Respuesta general (remisión completa y parcial) según criterios IWG de 2006
    -Respuesta completa de la médula ósea según criterios IWG de 2006
    -Mejora hematológica del núm absoluto de neutrófilos (CAN), núm de plaquetas y respuestas eritroideas, según criterios IWG de 2006
    -Mejoras de citogenética según evaluación mediante el cambio en aneuploidía en la médula ósea de conformidad con criterios IWG de 2006
    -Tiempo de transición a LMA:
    Definido para pacs con SMD AREB-1 y AREB-2, y leucemia mielomonocítica crónica (LMMC) (con entre el 10 % y el 20 % de blastocitos de la MO) por aumento de al menos el 50 % de blastocitos de la MO y más de un 20 % de blastocitos de la MO
    Definido para AREB-t mediante un aumento de al menos el 50 % de blastocitos de la MO
    -Puntuaciones (CdV) (cuestionario calidad de vida C30 de Organización Europea para la Investigación y el Tratamiento del Cáncer [EORTC]V3;
    -Incidencia infecciones
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. +/= 18 years of age;
    b. Diagnosis of MDS confirmed within 6 weeks prior to study entry according to WHO criteria or FAB classification;
    c. MDS classified as follows, according to WHO criteria and FAB classification:
    - RAEB-1 (5% to 9% BM blasts)
    - RAEB-2 (10% to 20% BM blasts)
    - CMML (10% to 20% BM blasts) and WBC < 13,000/microL
    - RAEB-t (21% to 30% BM blasts), meeting the following criteria:
    - WBC < 25 x 109/L at study entry o Stable WBC at least 4 weeks prior to study entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukophoresis;
    d. At least one cytopenia (ANC < 1800/microL or platelet count < 100,000/microL or hemoglobin [Hgb] <10 g/dL);
    e. Progression (according to 2006 IWG criteria) at any time after initiation of azacitidine or decitabine treatment during the past 2 years;or Failure to achieve complete or partial response
    or
    hematological improvement (according to 2006 IWG) after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine administered during the past 2 years;
    or
    Relapse after initial complete or partial response or hematological improvement (according to 2006 IWG criteria) observed after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine administered during the past 2 years;
    or
    Intolerance to azacitidine or decitabine defined by drug-related +/= Grade 3 liver or renal toxicity leading to treatment discontinuation during the past 2 years;
    f. Has failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation;
    g. Off all other treatments for MDS for at least 4 weeks. Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated;
    h. No medical need for induction chemotherapy;
    i. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
    j. Willing to adhere to the prohibitions and restrictions specified in this protocol;
    k. Patient (or patients legally authorized representative) must signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
    a.+/= 18 años de edad.
    b.Diagnóstico de SMD confirmado en el plazo de 6 semanas anterior a la incorporación en el estudio según los criterios de la OMS (apéndice 2) o la clasificación FAB (apéndice 3).
    c.SMD clasificada según sigue, de acuerdo con los criterios de la OMS y la clasificación FAB:
    - AREB-1 (del º5 % al 9 % de blastocitos de la MO)
    - AREB-2 (del 10 % al 20 % de blastocitos de la MO)
    - LMMC (del 10 % al 20 % de blastocitos de la MO) y WBC < 13.000/?l
    - AREB-t (del 21 % al 30 % de blastocitos de la médula ósea), que cumplan los criterios siguientes:
    -WBC < 25 x 109/l en el momento de la incorporación al estudio
    -WBC estable al menos 4 semanas antes de la incorporación al estudio y que no requiera intervención para el control de WBC con hidroxiurea, quimioterapia o leucoforesis;
    d.Al menos una citopenia (ANC < 1800/µl, cantidad de plaquetas < 100.000/µl o hemoglobina [Hb] < 10 g/dl).
    e.Progresión (de acuerdo con los criterios IWG de 2006; véase el apéndice 1) en cualquier momento después del inicio del tratamiento con azacitidina o decitabina durante los últimos 2 años; o incapacidad de alcanzar respuesta completa o parcial, o mejora hematológica (según IWG de 2006), después de al menos seis ciclos de 4 semanas de azacitidina o cuatro ciclos de 6 semanas de decitabina administrados durante los últimos 2 años; o recaída después de una respuesta completa o parcial inicial o mejora hematológica (de acuerdo con los criterios IWG de 2006) observada después de al menos seis ciclos de cuatro semanas de azacitidina o cuatro ciclos de 6 semanas de decitabina administrados durante los últimos 2 años; o intolerancia a la azacitidina o decitabina definida por efectos secundarios hepáticos o renales de grado +/= 3 que llevaron a la interrupción del tratamiento durante los últimos 2 años.
    f.No ha respondido a un trasplante de médula ósea, ha sufrido una recaída posterior a un trasplante de MO, no es apto para él u optó por no participar en un trasplante de MO.
    g.No ha recibido ningún otro tratamiento para el SMD durante al menos 4 semanas. Se permite el uso de Filgrastim (G-CSF) y eritropoyetina antes y durante el estudio, según esté clínicamente indicado.
    h.Sin necesidad médica para la quimioterapia de inducción.
    i.Estado general ECOG de 0, 1 o 2
    j.Dispuesto a cumplir las prohibiciones y restricciones especificadas en este protocolo.
    k.El paciente (o el representante autorizado legal del paciente) debe haber firmado un documento de consentimiento informado que indique que el paciente comprende el propósito y los procedimientos que requiere el estudio y está dispuesto a participar en él.
    E.4Principal exclusion criteria
    Patients with any of the following will not be enrolled in the study:
    a. Anemia due to factors other than MDS (including hemolysis or gastrointestinal [GI] bleeding) unless stabilized for 1 week after RBC transfusion;
    b. Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast;
    c. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
    d. Active infection not adequately responding to appropriate therapy;
    e. Total bilirubin +/= 1,5 mg/dL not related to hemolysis or Gilbert's disease;
    f. Alanine transaminase (ALT)/aspartate transaminase (AST)+/=2.5 x upper limit of normal (ULN);
    g. Serum creatinine +/=2.0 mg/dL;
    h. Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of <130 mEq/L);
    i. Female patients who are pregnant or lactating;
    j. Patients who are unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device, double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study;
    k. Female patients with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin (HCG) pregnancy test at screening;
    l. Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start;
    m. Uncontrolled hypertension (defined as a systolic pressure +/=160 mmHg and/or a diastolic pressure +/=110 mmHg);
    n. New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures;
    o. Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy;
    p. Prior treatment with low-dose cytarabine during the past 2 years;
    q. Investigational therapy within 4 weeks of starting ON 01910.Na;
    r. Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
    Los pacientes con algunas de las características siguientes no pueden participar en el estudio:

    a.Anemia debido a factores distintos a la SMD (incluyendo hemolisis o hemorragia gastrointestinal [GI]), a no ser que se haya estabilizado durante 1 semana después de la transfusión de HEM.
    b.Todo cáncer activo en el último año, excepto carcinoma basocelular, carcinoma espinocelular o carcinoma in situ de cuello uterino o mama.
    c.Enfermedad intermitente no controlada, incluyendo, sin limitarse a ellas, insuficiencia cardíaca congestiva sintomática, angina de pecho inestable o arritmia cardíaca.
    d.Infección activa que no responde adecuadamente al tratamiento apropiado.
    e.Bilirrubina total +/= 1,5 mg/dl no relacionada con hemolisis ni enfermedad de Gilbert.
    f.Alanina transaminasa (ALT)/aspartato transaminasa (AST) +/= 2,5 x límite superior de lo normal (LSN).
    g.Creatinina sérica +/= 2,0 mg/dl.
    h.Ascitis que requiera gestión médica activa, incluyendo paracentesis o hiponatriemia (definida como un valor de sodio sérico < 130 mEq/l).
    i.Pacientes mujeres embarazadas o en período de lactancia.
    j.Pacientes que no estén dispuestos a seguir estrictos requisitos de anticoncepción (que incluyen el uso de preservativos para los varones con parejas sexuales; para las mujeres: Anticonceptivos orales con receta [píldoras anticonceptivas], inyecciones anticonceptivas, dispositivo intrauterino, método de doble barrera [espuma o gel espermicida con preservativo o diafragma], parche anticonceptivo o esterilización quirúrgica) antes de la incorporación y durante el estudio.
    k.Pacientes mujeres en edad de concebir que no hayan obtenido un resultado negativo en la prueba de embarazo con gonadotropina coriónica humana beta (beta-HCG) en el momento de la selección.
    l.Operación de cirugía mayor sin recuperación completa u operación de cirugía mayor en las 3 semanas anteriores al inicio del tratamiento con ON 01910.Na.
    m.Hipertensión arterial incontrolada (definida como una presión sistólica +/= 160 mmHg y/o una presión diastólica +/= 110 mmHg).
    n.Crisis de nuevo inicio (en los 3 meses antes de la primera dosis de ON 01910.Na) o crisis mal controladas.
    o. Cualquier otro agente en investigación simultáneo, o quimioterapia, radioterapia o inmunoterapia simultánea.
    p. Tratamiento anterior con citarabina de dosis baja durante los 2 años anteriores.
    q. Tratamiento en investigación en las 4 semanas anteriores al inicio de la administración de ON 01910.Na.
    r. Tratamiento en investigación en las 4 semanas anteriores al inicio de la administración de ON 01910.Na.
    E.5 End points
    E.5.1Primary end point(s)
    The following outcomes will be assessed:
    - Overall survival
    - Blastic response in BM
    - Progression to AML defined as:
    * +/=50% BM blasts increase and >20% BM blasts for RAEB-1, RAEB-2, and CMML patients
    * +/=50% BM blasts increase for RAEB-t patients
    - Change in BM cytogenetics
    - Changes in ANC
    - Changes in platelet count and platelet transfusions requirements
    - Changes in Hgb and RBC transfusion requirements
    - QOL questionnaire using EORTC QLQ-C30 version 3
    - Incidence of infections (treated with intravenous antimicrobials) and bleeding episodes (and their severity)
    Se evaluarán los criterios de valoración siguientes:
    -supervivencia general
    -respuesta de los blastocitos en la MO
    -progresión a LMA, definida como:
    -aumento de los blastocitos en la MO en +/= 50 % y > 20 % de blastocitos en la MO, para pacientes con AREB-1, AREB-2 y LMMC
    -aumento de blastocitos en la médula ósea +/= 50 % en pacientes con AREB-t
    -cambio en las características citogenéticas de la MO
    -cambios en la ANC
    -cambios en la cantidad de plaquetas y en los requisitos de transfusiones de plaquetas
    -cambios en los requisitos de transfusión de hemoglobina y HEM
    -cuestionario de CdV usando la versión 3 del cuestionario C30 de EORTC
    -incidencia de infecciones (tratadas con antimicrobianos por vía intravenosa) y episodios hemorrágicos (y su gravedad)
    E.5.1.1Timepoint(s) of evaluation of this end point
    During and at the end of study
    Durante y al final del Estudio
    E.5.2Secondary end point(s)
    None defined
    No definido
    E.5.2.1Timepoint(s) of evaluation of this end point
    None given
    Sin determinar
    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 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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    France
    Germany
    Italy
    Spain
    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
    Last patient last visit. Patients will be treated until progression or until death from any cause, whichever comes first.
    Último paciente, última visita. Los pacientes serán tratados hasta la progresión o hasta la muerte por cualquier causa, lo que ocurra primero.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 270
    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)
    NA
    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 Decision2012-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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