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    Summary
    EudraCT Number:2011-000490-30
    Sponsor's Protocol Code Number:METTEN-01
    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:2011-02-28
    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 number2011-000490-30
    A.3Full title of the trial
    Phase II randomised, open-label, multicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer.
    Ensayo fase II, aleatorizado, abierto, multicéntrico, de tratamiento neoadyuvante con quimioterapia y trastuzumab con o sin la adición de metformina en mujeres diagnosticadas de cáncer de mama primario HER2/ErbB2 positivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II randomised, open-label, multicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer.
    Ensayo fase II, aleatorizado, abierto, multicéntrico, de tratamiento neoadyuvante con quimioterapia y trastuzumab con o sin la adición de metformina en mujeres diagnosticadas de cáncer de mama primario HER2/ErbB2 positivo.
    A.4.1Sponsor's protocol code numberMETTEN-01
    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 SponsorInstitut Català d'Oncologia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinisterio de Sanidad, Politica Social e Igualdad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Català d'Oncologia de Girona
    B.5.2Functional name of contact pointNeus Bosch Pont
    B.5.3 Address:
    B.5.3.1Street AddressAvda. França, s/n - Unidad de Investigación Clínica
    B.5.3.2Town/ cityGirona
    B.5.3.3Post code17007
    B.5.3.4CountrySpain
    B.5.4Telephone number0034972225827
    B.5.5Fax number0034972225842
    B.5.6E-mailnbosch@iconcologia.net
    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 METFORMINA TEVA 850 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical 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 INNMETFORMINA HIDROCLORURO
    D.3.9.3Other descriptive nameMETFORMIN HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 Yes
    D.2.1.1.1Trade name HERCEPTIN 150 mg polvo para concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Powder for injection
    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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.3Other descriptive nameTRASTUZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 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 PACLITAXEL HOSPIRA 6 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA PRODUCTOS FARMACÉUTICOS Y HOSPITALARIOS, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form 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 INNPACLITAXEL
    D.3.9.3Other descriptive namePACLITAXEL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Women with stage II-III, HER2/ErbB2-positive primary breast cancer elegible for neoadjuvant treatment.
    Cáncer de mama primario que sobreexpresa o amplifica HER2.
    E.1.1.1Medical condition in easily understood language
    Primary breast cancer
    Cáncer de mama primario
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006279
    E.1.2Term Breast neoplasm
    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 determine the efficacy of adding metformin concomitantly with chemotherapy and trastuzumab in the neoadjuvant treatment of patients with HER2-positive operable breast cancer as measured by the number of pathological complete responses.
    Determinar la eficacia medida mediante el nº de respuestas completas patológicas alcanzadas de la Metformina concomitante con quimioterapia y Trastuzumab en el tratamiento neoadyuvante de pacientes con cáncer de mama HER2 positivo operable.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of both treatment regimens.
    - To determine the 5-years Disease Free Survival (DFS) from last patient randomization.
    - To evaluate the cardiac toxicity associated to both treatment schedules.
    - To examine biomarkers´ activity/expression functionally related with AMPK. mTor signaling pathway in tumor tissue
    - To determine circulating insulin levels in patients? serum .
    -Evaluar seguridad y tolerabilidad de ambos esquemas de tratamiento.
    - Determinar SLE (Supervivencia libre de enfermedad) a los cinco años desde la aleatorización de la última paciente.
    - Evaluar la toxicidad cardíaca asociada a ambos esquemas de tratamiento.
    - Analizar la expresión y/o actividad de biomarcadores relacionados funcionalmente con la via de señalización AMPK ? mTOR en el tejido tumoral.
    - Determinar niveles circulantes de insulina en el suero de las pacientes.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    subestudio farmacogenómico en pacientes participantes en el estudio METTEN-01 tratados con Metformina. Versión Hoja información al paciente, versión 1, del 12 de abril del 2012
    subestudio farmacogenómico en pacientes participantes en el estudio METTEN-01 tratados con Metformina. Versión Hoja información al paciente, versión 1, del 12 de abril del 2012
    E.3Principal inclusion criteria
    1. Mujeres.
    2. Edad 18-75 años.
    3. Puntuación 0-1 de la clasificación ECOG (Eastern Cooperative Oncology Group) (ver ApéndiceB).
    4. Cáncer de mama invasivo confirmado histológicamente (incluido el cáncer de mama inflamatorio y el cáncer de mama multifocal:)
    - Tumor primario mayor de 2 cm. de diámetro, medido por examen clínico y por mamografía o ecografía.
    - Cualquier N
    - Sin evidencia de metástasis (M0), (un ganglio supraclavicular aislado afectado está permitido).
    Se seguirá la 7ª edición del AJCC Cancer Staging Manual (ver Apéndice C).
    5. Sobre-expresión y/o amplificación de HER2 en el componente invasivo del tumor primario, definido según el siguiente criterio:
    - IHC 3+
    - IHC 2+ y FISH/CISH positivo
    6. Estado conocido de los receptores hormonales.
    7. Función hematopoyética:
    - Recuento absoluto de neutrófilos ?1,5 x109/L
    - Recuento de plaquetas ?100 x109/L
    - Hemoglobina ?9 g/dl
    8. Función hepática:
    - Bilirrubina sérica total ?1,5 x límite superior normal (LSN).
    - AST y ALT ?2,5 x LSN
    - Fosfatasa alcalina ?2,5 x LSN
    - Glucosa en ayunas ?70 mg/dl
    9. Función renal:
    - Creatinina?1,5 x LSNCódigo del protocolo: METTEN-01 Confidencial Versión 2 Fecha 15/05/2011 23
    10. Cardiovascular:
    - FEVI basal ?50% medida mediante ecocardiografía (ECO) o rastreo MUGA (del inglés, Multiple Gate Acquisition)
    11. 20 ?IMC? 30
    12. Prueba de embarazo negativa en los 7 días previos a la aleatorización (en las mujeres potencialmente fértiles).
    13. Las mujeres fértiles deben utilizar un método anticonceptivo efectivo.
    14. Consentimiento informado por escrito.
    1. Mujeres.
    2. Edad 18-75 años.
    3. Puntuación 0-1 de la clasificación ECOG (Eastern Cooperative Oncology Group) (ver ApéndiceB).
    4. Cáncer de mama invasivo confirmado histológicamente (incluido el cáncer de mama inflamatorio y el cáncer de mama multifocal:)
    - Tumor primario mayor de 2 cm. de diámetro, medido por examen clínico y por mamografía o ecografía.
    - Cualquier N
    - Sin evidencia de metástasis (M0), (un ganglio supraclavicular aislado afectado está permitido).
    Se seguirá la 7ª edición del AJCC Cancer Staging Manual (ver Apéndice C).
    5. Sobre-expresión y/o amplificación de HER2 en el componente invasivo del tumor primario, definido según el siguiente criterio:
    - IHC 3+
    - IHC 2+ y FISH/CISH positivo
    6. Estado conocido de los receptores hormonales.
    7. Función hematopoyética:
    - Recuento absoluto de neutrófilos ?1,5 x109/L
    - Recuento de plaquetas ?100 x109/L
    - Hemoglobina ?9 g/dl
    8. Función hepática:
    - Bilirrubina sérica total ?1,5 x límite superior normal (LSN).
    - AST y ALT ?2,5 x LSN
    - Fosfatasa alcalina ?2,5 x LSN
    - Glucosa en ayunas ?70 mg/dl
    9. Función renal:
    - Creatinina?1,5 x LSNCódigo del protocolo: METTEN-01 Confidencial Versión 2 Fecha 15/05/2011 23
    10. Cardiovascular:
    - FEVI basal ?50% medida mediante ecocardiografía (ECO) o rastreo MUGA (del inglés, Multiple Gate Acquisition)
    11. 20 ?IMC? 30
    12. Prueba de embarazo negativa en los 7 días previos a la aleatorización (en las mujeres potencialmente fértiles).
    13. Las mujeres fértiles deben utilizar un método anticonceptivo efectivo.
    14. Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Prior treatment for primary invasive breast cancer.
    2. Bilateral breast cancer.

    3. Precedent medical history less than 10 years or present history for other malignant neoplasia, except in situ carcinoma of the cervix and basocellular and epidermoid skin carcinoma. Previous diagnosis of melanoma or breast cancer are excluded.

    4. Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarct, uncontrolled hypertension, dyspnea at rest, or chronic therapy with oxygen.

    5. Metabolic disease (diabetes mellitus type I or II, obesity (BMI ? 30), hyperglycemia (preprandial glucose >128 mg/dl), hypercholesterolemia or hypertrigliceridemia ? grade 3 according to CTC-NCIC version 3.0.
    6. History of metabolic acidosis.
    7. Chronic neumopathy or respiratory restriction.
    8. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
    9. Active or uncontrolled infection.
    10. Enolism. (daily media consumption of more than 3 alcoholic beverage intake)
    11. Hepatic insufficiency.
    12. Renal insufficiency (calculated CrCl < 60 mL/min).
    13. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent by the patient.
    14. Malabsorption syndrome, with disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
    15. Concurrent treatment with therapies that can alter insulin levels (including chronic treatment with oral corticoids).
    16. Concurrent treatment with an investigational drug or participation in another therapeutic clinical trial.
    17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab, metformin or their excipients. Glucose or galactos absorption problems and hereditary galactose intolerance.
    18. Pregnant or lactating women.
    and galactosemia o hereditary galactosemia intolerance.
    19. Sociologic, familiar or geographical conditions that may compromise clinical trial protocol compliance.
    1. Tratamiento previo para el cáncer de mama invasivo primario.
    2. Cáncer de mama bilateral.
    3. Antecedentes de menos de 10 años o historia actual de otra neoplasia maligna, salvo el carcinoma in situ del cuello uterino y el carcinoma basocelular y epidermoide de piel. Se excluyen los diagnósticos previos de cáncer de mama o de melanoma.
    4. Historia conocida de angina no controlada o sintomática, arritmias clínicamente significativas, insuficiencia cardíaca congestiva, infarto transmural de miocardio, hipertensión no controlada, disnea en reposo u oxigenoterapia crónica.
    5. Enfermedad metabólica (diabetes mellitus tipo I o II, obesidad (IMC?30), hiperglicemia (glucosa en ayunas>128 mg/dl), hipercolesterolemia o hipertrigliceridemia ?grado 3 según los Criterios Comunes de Toxicidad (CTC-NCIC) versión 3.0 (ver Apéndice D).
    6. Historia de acidosis metabólica.
    7. Neumopatia crónica o compromiso respiratorio.
    8. Enfermedad o trastorno concurrente que haga que la paciente sea inapropiada para participar en el estudio, o cualquier trastorno médico grave que pueda interferir con la seguridad de la paciente.
    9. Infección activa o no controlada.
    10. Enolismo (consumo medio de >3 bebidas alcohólicas por día).
    11. Insuficiencia hepática.
    12. Insuficiencia renal (aclaramiento de creatinina < 60 ml/mn).
    13. Demencia, estado mental alterado, o cualquier trastorno psiquiátrico que impida que la paciente pueda entender o dar su consentimiento informado.
    14. Síndrome de malabsorción, enfermedad que afecte significativamente a la función gastrointestinal, o resección de estómago o intestino delgado.
    15. Tratamiento concurrente con fármacos que puedan alterar los niveles de insulina (incluyendo tratamiento crónico con corticoides orales).
    16. Tratamiento concurrente con un fármaco en investigación o participación en otro ensayo clínico terapéutico.
    17. Reacción de hipersensibilidad inmediata o tardía conocida o idiosincrasia a fármacos químicamente relacionados con metformina, trastuzumab o sus excipientes. Problemas de absorción de glucosa o galactosa e intolerancia hereditaria a galactosa.
    18. Mujeres en estado de gestación o lactancia.
    19. Condiciones sociológicas, familiares o geográficas que puedan comprometer el cumplimiento del protocolo del ensayo clínico
    E.5 End points
    E.5.1Primary end point(s)
    -Pathological Complete Response Rate (pCR) . Percentage of patients who present pathological complete response, defined as the absence of infiltrating carcinoma in resected materials and the axilla or the exclusive presence of in situ non-invasive cancer in resected material
    (number of patients with pCR)/(total patient numbers according to per protocol population) x 100
    Tasa de respuesta patológica completa (RCp): Porcentaje de pacientes que presentan respuesta patológica completa, definida como ausencia de carcinoma infiltrante en la pieza resecada y en la axila o la presencia exclusiva de cáncer in situ no invasivo en la pieza resecada.
    ? (Nº paciente con RCp)/(Nº total de pacientes según población por protocolo)x100
    E.5.1.1Timepoint(s) of evaluation of this end point
    It will assess the pathological response in surgical specimen obtained after completion of neoadjuvant therapy. The first efficacy analysis will be performed when available 37 responses evaluated in both groups of treatment, according to two-step method of Jung
    Se evaluará la respuesta patológica en la pieza quirúrgica obtenida tras la finalización del tratamiento neoadyuvante. El primer análisis de eficacia será realizado cuando se disponga de 37 respuestas evaluables en ambos grupos de tratamiento, según el método de dos etapas de Jung.
    E.5.2Secondary end point(s)
    1.-Safety and Tolerability. To determine the safety profile from adverse events reported by patients. Every AE will be recorded until 28 days after last study drug intake. Non serious AE related with the drug medication appeared up to 6 month after the last study drug intake must be reported.
    2.- 5 year disease-free survival from diagnosis: probability of disease relapse or death by any cause.
    3.- Cardiotoxicity rate. Number of patients with cardiotoxicity (according to CTCAE V4.0 criteria) divided among the total patients number or the total number of patients per protocol ( x100).
    4.- Biomarkers
    5.- Insulin levels.
    1.-Seguridad y tolerabilidad: Se determinará el perfil de seguridad a partir de los AA notificados por los pacientes. Se registrarán todos los AA que se manifiesten hasta 28 días después de la última dosis de la medicación del estudio. Los AA no graves relacionados con el tratamiento en estudio que aparezcan hasta 6 meses después de la administración de la última dosis deberán comunicarse.
    2.-Supervivencia libre de enfermedad a los 5 años del diagnóstico: probabilidad de recidiva de la enfermedad o muerte por cualquier causa.
    3.-Tasa de toxicidad cardíaca: Nº de pacientes que presentan toxicidad cardíaca según los criterios CTCAE v 4.0 dividido por el número total de pacientes o por el número de pacientes por protocolo (x100).
    4.-Biomarcadores.
    5.-Niveles insulina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It will be held at the end when making the final statistical analysis, after collecting all the study data.
    Se realizará al final cuando se realice el análisis estadístico final previa recogida de todos los datos del estudio.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 will be the end of the trial
    El final del ensayo coincide con la última visita del último sujeto reclutado en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 133
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state178
    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)
    Not applicable.
    No aplica.
    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 Decision2011-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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