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    Summary
    EudraCT Number:2010-021196-85
    Sponsor's Protocol Code Number:BNIT-PRV-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-11-24
    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 number2010-021196-85
    A.3Full title of the trial
    A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
    Ensayo de eficacia aleatorizado de doble ciego y fase 3 de PROSTVAC-V/F ± FEC-GM en hombres que tienen cáncer de próstata asintomático o mínimamente sintomático metastásico resistente a la castración.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
    Determinar si PROSTVAC sólo o en combinación con FEC-GM es efectivo en prolongar la supervivencia global en hombres con cáncer de próstata metastático asintomático o mínimamente sintomático, resistente a la castración.
    A.4.1Sponsor's protocol code numberBNIT-PRV-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01322490
    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 SponsorBN ImmunoTherapeutics, 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 supportBN ImmunoTherapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBN ImmunoTherapeutics, Inc.
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street Address2425 Garcia Avenue
    B.5.3.2Town/ cityMountain View, CA
    B.5.3.3Post code94043
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 650 681 4660
    B.5.5Fax number+1 866 268 2676
    B.5.6E-mailwayne.godfrey@bn-it.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 namePROSTVAC-V
    D.3.2Product code PROSTVAC-V
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1225283-43-1
    D.3.9.2Current sponsor codePROSTVAC-V
    D.3.9.3Other descriptive namePROSTVAC-V-PSA-TRICOM in aqueous solution for injection
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200000000
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 namePROSTVAC-F
    D.3.2Product code PROSTVAC-F
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1225283-42-0
    D.3.9.2Current sponsor codePROSTVAC-F
    D.3.9.3Other descriptive namePROSTVAC-F: PROSTVAC-F-PSA-TRICOM in aqueous solution for injection
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000000
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP 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 Leukine
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Corporation
    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 nameGM-CSF
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 123774-72-1
    D.3.9.3Other descriptive nameGRANULOCYTE MACROPHAGE COLONY STIM FACTOR
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
    Cáncer de próstata asintomático o mínimamente sintomático metastático, resistente a la castración.
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer in men who experience few or no symptoms and do not respond to treatment with hormones.
    Hombres con cáncer de próstata con pocos o sin síntomas y que no responden al tratamiento con hormonas.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate 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 ascertain whether the survival of patients randomized to Arm V+G (PROSTVAC plus GM-CSF) or to Arm V (PROSTVAC) is superior to that from patients randomized to Arm P (placebo control).
    Determinar si la supervivencia de pacientes aleatorizados al brazo V+G (PROSTVAC+ FEC-GM) o al brazo V (PROSTVAC) es superior a los pacientes aleatorizados la brazo P (Placebo control).
    E.2.2Secondary objectives of the trial
    To ascertain whether a greater proportion of patients randomized to Arm V+G or to Arm V remain event-free at six months as compared to the patients randomized to Arm P.
    Determinar si es mayor la proporción de pacientes aleatorizados al brazo V+G o al brazo V que permanecen sin eventos a los 6 meses comparado con los pacientes aleatorizados al brazo P.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent
    2. Men, 18 - 85 years of age
    3. Castrate testosterone level < 50 ng/dl
    4. Documented metastatic prostate cancer with progressive disease post surgical castration during androgen suppression therapy or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
    a. Radiological progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer.
    OR
    b. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
    5. Chemotherapy naïve. No prior chemotherapy for metastatic prostate cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate cancer is permissible if >3 years prior.
    6. Vaccinia-experienced (previous smallpox vaccination)
    7. ECOG Performance Score of 0 or 1
    8. Life expectancy >= 1 year
    9. Bone Marrow function:
    - Absolute neutrophil count >= 1,500/mm3
    - Hemoglobin >= 10 g/dL
    - Platelet count >= 100,000/mm3
    10. Hepatic Function:
    - AST and ALT <= 2.5 times upper limit of normal (ULN)
    - Bilirubin <= 1.5 times ULN
    11. Renal Function:
    - Creatinine <= 1.5 times ULN
    12. Currently using a GnRH agonist or antagonist (unless surgically castrated)
    1.Consentimiento informado firmado
    2.Hombres de 18 a 85 años de edad.
    3.Niveles de castración testosterona < 50 ng/dl.
    4.Cáncer de próstata metastásico documentado con enfermedad progresiva después de la castración quirúrgica, durante el tratamiento de privación androgénica o durante el tratamiento de bloqueo androgénico completo y retirada. Documentado por el criterio A (progresión radiológica) O BIEN por el criterio B (progresión por PSA).
    a.Progresión radiológica definida como cualquier lesión ósea nueva o que aumenta de tamaño, o enfermedad creciente de ganglios linfáticos, compatible con cáncer de próstata.
    O BIEN b.Progresión de PSA definida por la secuencia de valores crecientes separados por > 1 semana (2 valores crecientes separados) sobre un umbral mínimo de 2 ng/ml(criterios de elegibilidad PSA del PCWG2).
    5.Sin quimioterapia previa.Sin quimioterapia previa para cáncer de próstata metastásico.La quimioterapia complementaria o neocomplementaria para cáncer de próstata primario es permisible si se hizo > 3 años antes.
    6.Experiencia con la vacuna (vacunación previa contra la viruela).
    7.Estado general de ECOG de 0 ó 1.
    8.Esperanza de vida >= 1 año.
    9.Función de la médula ósea:
    -Recuento absoluto de neutrófilos > =1.500/mm^3
    -Hemoglobina >= 10 g/dl
    -Recuento de plaquetas > o = 100.000/mm^3
    10. Función hepática:
    -AST y ALT <= 2,5 veces el límite superior normal (LSN)
    -Bilirrubina <= 1,5 veces el LSN
    11. Función renal: - Creatinina <= 1,5 veces el LSN.
    12. Estar utilizando actualmente un agonista o antagonista de la GnRH (salvo castración quirúrgica).
    E.4Principal exclusion criteria
    1. Cancer-related pain requiring scheduled opioid narcotics for control (prn <= 2x per week is allowed)
    2. Metastasis to organ systems other than lymph nodes and/or bone
    3. LDH >= 2 times ULN
    4. Alkaline phosphatase ? 2 times ULN
    5. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. A minimum of 3 PSA level determinations, at least 2 weeks apart (over a 6 month time-period), is required for assessment.
    6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer
    7. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC. There is no exclusion to previous experimental therapy provided dosing/treatment is completed at least 30 days prior to the first planned dose of vaccine unless otherwise noted (#5, #14 this section).
    8. History of prior malignancies other than prostate cancer within the past 3 years, excluding basal or squamous cell carcinoma of the skin
    9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
    10. Significant medical abnormality (defined as a pre-existing AE/condition >=Grade 3 according to NCI CTCAE v 4.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter (or Clinically Significant as defined by institutional normal ranges, but in the opinion of the Investigator, consistent with values seen for patients with mCRPC) may be eligible provided a written approval is granted by the study Medical Monitor prior to enrollment.
    11. Confirmed positive for HIV, hepatitis B, and /or hepatitis C
    12. Prior solid organ or bone marrow transplant
    13. Immunodeficiency or splenectomy
    14. Concurrent immunosuppressive therapy
    15. Inflammatory eye disease requiring steroid treatment
    16. Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
    17. History of or active autoimmune disease. Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosis, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or Graves disease. Persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
    18. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin), or GM-CSF. Patients with a known or suspected allergy to radiological contrast agents are eligible, but this must be noted in the patient's medical history and in the chart notes.
    19. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
    20. Previous adverse reactions to smallpox vaccination
    21. Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children <= 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
    22. Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
    23. Study personnel
    1.Dolor relacionado con el cáncer que tengan pautados opioides para tratar el dolor (prn <= 2 veces por semana está permitido).
    2.Metástasis en sistemas orgánicos que no sean ganglios linfáticos y/o huesos.
    3.LDH >= 2 veces el LSN.
    4.Fosfatasa alcalina >= 2 veces el LSN.
    5.PSA estimada que se duplique en < de 1 mes según se establezca en el plazo de 6 meses de la primera dosis prevista de vacuna o placebo.Se requiere para la evaluación un mínimo de determinaciones de nivel de 3 PSA, con una separación de por lo menos 2 semanas (en un período de 6 meses).
    6.Inmunoterapia para el cáncer de próstata concomitante o previa con Provenge (sipuleucel-T).
    7.Uso de un producto en investigación en el plazo de 30 días (o 60 días para un tratamiento basado en anticuerpos) de la primera dosis planeada de PROSTVAC.No hay exclusión de tratamiento experimental previo siempre que las dosis o el tratamiento se hayan completado al menos 30 días antes de la primera dosis planeada de vacuna salvo que se especifique lo contrario (puntos 5 y 14 de esta sección).
    8.Antecedentes de neoplasias que no sean cáncer de próstata en el plazo de los últimos 3 años, excepto carcinoma basocelular o carcinoma espinocelular de la piel.
    9.Insuficiencia cardíaca congestiva (NYHA clase II, III o IV), angina de pecho inestable, arritmia ventricular o arritmia auricular hemodinámicamente significativa, o enfermedades cardiovasculares tales como accidente cerebrovascular o infarto de miocardio (actuales o en los últimos 6 meses).
    10.Anomalía médica significativa (definida como afección o reacciones adversas preexistentes >=grado 3 según NCI CTCAE v. 4.0).Pacientes con antecedentes conocidos de parámetro de laboratorio NO SIGNIFICATIVO CLÍNICAMENTE (o clínicamente significativos según lo definido por intervalos institucionales normales, pero que según la opinión del investigador coincidan con valores vistos para pacientes con CPmRC) pueden ser elegibles, siempre que el monitorr médico del estudio otorgue una aprobación por escrito antes de la inclusión.
    11.Resultado positivo confirmado para VIH, hepatitis B y/o hepatitis C.
    12.Trasplante previo de un órgano o médula ósea.
    13.Inmunodeficiencia o esplenectomía.
    14.Tratamiento inmunosupresor concomitante.
    15.Enfermedad ocular inflamatoria que requiera tratamiento con esteroides.
    16.Administración crónica (definida como diaria o de cada dos días para uso continuado > 14 días) de corticosteroides sistémicos en el plazo de 28 días de la primera dosis planeada de PROSTVAC.Está permitido el uso de esteroides inhalados, aerosoles nasales y pomadas tópicas para áreas reducidas del cuerpo.
    17.Antecedentes de enfermedad autoinmune o enfermedad autoinmune activa.Neutropenia autoinmune, trombocitopenia o anemia hemolítica, lupus eritematoso sistémico, síndrome de Sjogren, esclerodermia, miastenia grave, síndrome de Goodpasture, enfermedad de Addison, tiroiditis de Hashimoto o enfermedad de Graves-Basedow.No se excluye a las personas con vitíligo.No se excluye a la diabetes si está bien controlada.
    18.Alergia conocida al huevo, a productos derivados de huevos, a antibióticos aminoglucósidos (por ejemplo, gentamicina o tobramicina) o a FEC-GM. Los pacientes con alergia comprobada o potencial a agentes de contraste radiológicos son elegibles, pero esto debe indicarse en la anamnesis o en la historia clínica del paciente.
    19.Antecedentes de dermatitis atópica o afección activa de la piel (aguda, crónica, exfoliativa) que altera la epidermis.
    20.Reacciones adversas previas a vacunación contra la viruela.
    21.Imposibilidad de evitar el contacto directo o en el hogar con los siguientes individuos de alto riesgo durante tres semanas después de la vacunación del día 1:(a) niños <= 3 años de edad, (b) mujeres lactantes o embarazadas, (c) individuos con eccema extenso previo o concomitante, u otras enfermedades eccematoides de la piel, o (d) individuos inmunodeprimidos, como aquellos con VIH.
    22.Toda afección que, en la opinión del investigador, evitaría la participación plena en este ensayo (incluido el seguimiento a largo plazo) o interferiría en la evaluación de los criterios de valoración del ensayo.
    23.Personal del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Overall survival
    Supervivencia global.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study closure or death.
    Cierre del ensayo o muerte.
    E.5.2Secondary end point(s)
    - Proportion of event-free patients (radiological progression or chemotherapy initiation) at six months compared to placebo
    Proporción de pacientes libres de eventos (progresión radiológica o iniciación de quimioterápia) a los seis meses comparado con placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Six months.
    Seis 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 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 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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Australia
    Austria
    Belgium
    Canada
    Chile
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Iceland
    Israel
    Lithuania
    Mexico
    Netherlands
    Panama
    Poland
    Russian Federation
    Spain
    Switzerland
    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
    The end of the trial is defined as the last anticipated visit of the last patient enrolled.
    El final del ensayo se define como la última visita prevista del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 900
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 349
    F.4.2.2In the whole clinical trial 1200
    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)
    Standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-03-16
    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 StatusPrematurely Ended
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