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    Summary
    EudraCT Number:2012-002451-41
    Sponsor's Protocol Code Number:NX1207-IT-CL0414
    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:2013-04-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-002451-41
    A.3Full title of the trial
    EFFICACY AND SAFETY OF A SINGLE TRUS-GUIDED INTRAPROSTATIC INJECTION OF NX-1207 IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA:
    A PHASE III EUROPEAN CLINICAL STUDY
    EFICACIA Y SEGURIDAD DE UNA SOLA INYECCIÓN INTRAPROSTÁTICA DE NX-1207 GUIADA POR ECOGRAFÍA TRANSRECTAL EN PACIENTES CON SÍNTOMAS DEL TRACTO URINARIO INFERIOR ASOCIADOS A HIPERPLASIA PROSTÁTICA BENIGNA: ESTUDIO EUROPEO DE FASE III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NOVEL INJECTION THERAPY FOR PATIENT WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
    Nueva inyección para el tratamiento de pacientes con síntomas del tracto urinario inferior asociados a hiperplasia prostática benigna.
    A.4.1Sponsor's protocol code numberNX1207-IT-CL0414
    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 SponsorRecordati S.p.A.
    B.1.3.4CountryItaly
    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 supportRecordati S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRecordati S.p.A.
    B.5.2Functional name of contact pointClin. Proj. Leader - Medical Dep.
    B.5.3 Address:
    B.5.3.1Street AddressVia Matteo Civitali, 1
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20148
    B.5.3.4CountryItaly
    B.5.4Telephone number+39(0)248787183
    B.5.5Fax number+39(0)248787668
    B.5.6E-mailmiotto.f@recordati.it
    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 nameNX-1207
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraprostatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeNX-1207
    D.3.9.3Other descriptive nameNYM-4805
    D.3.9.4EV Substance CodeSUB117036
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 RoleComparator
    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 Omexel L.p.
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 INNTAMSULOSIN HYDROCHLORIDE
    D.3.9.1CAS number 106463-17-6
    D.3.9.4EV Substance CodeSUB04673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
    Tratamiento de los síntomas del tracto urinario inferior asociados a la hiperplasia prostática benigna.
    E.1.1.1Medical condition in easily understood language
    BENIGN PROSTATIC HYPERPLASIA
    Hiperplasia prostática benigna
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast 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 core of the study is to demonstrate that a single TRUS-guided intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of LUTS associated with benign prostatic hyperplasia (LUTS/BPH) in patients not adequately controlled by medical therapy with ?-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.
    El objetivo principal del estudio primario es demostrar que una sola inyección intraprostática de NX-1207 guiada por ETR proporciona una mejoría duradera de los STUI asociados a HPB en pacientes insuficientemente controlados mediante el tratamiento farmacológico con bloqueantes α, lo que se evalúa mediante la variación en la puntuación total de la Escala internacional de síntomas prostáticos (IPSS) con respecto a la puntuación basal.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate:
    - the effects on storage and voiding LUTS
    - the effects on Quality of Life (QoL)
    - the effects on maximum urinary flow rate (Qmax), post void residual volume and prostate volume
    - the safety profile of the procedure and of the study drug
    - the patient?s global assessment of treatment
    - the persistence of the treatment effects at 18 and 24 months after the NX-1207 injection
    Los objetivos secundarios del estudio primario consisten en evaluar:
    - los efectos en los STUI de almacenamiento y vaciamiento
    - los efectos en la calidad de vida (CV)
    - Los efectos en el flujo urinario máximo (Qmax), volumen residual posmiccional y volumen prostático
    - el perfil de seguridad del procedimiento y del fármaco del estudio
    - la evaluación global del tratamiento por el paciente
    El objetivo principal de las visitas de seguimiento es evaluar la persistencia de los efectos del tratamiento 18 y 24 meses después de la inyección de NX-1207.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent;
    2. Age 45 or older;
    3. Medical history of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH);
    4. Use of a marketed ?-blocker for LUTS/BPH in the last 8 weeks;
    5. LUTS/BPH not adequately controlled by medical therapy with alfa blockers;
    6. Presence of moderate-severe LUTS (IPSS >/= 15) at screening and at baseline (after a 4 week single-blind run-in period with tamsulosin 0.4 mg QD);
    7. Prostate Volume >/= 30 mL and </= 70 mL (as assessed by TRUS);
    8. Qmax < 15 mL/sec based on a minimum void of 125 mL;
    9. Agree not to use any other approved or experimental BPH or overactive bladder (OAB) medication anytime during the core study;
    10. Agree to perform follow-up visits even in case of oral treatment discontinuation before study end;
    11. Satisfactory compliance to run-in medication at Visit 2 (baseline).
    1. Consentimiento informado firmado;
    2. Edad de 45 años o más;
    3. Antecedentes de STUI/HPB;
    4. Uso de un bloqueante α comercializado para STUI/HPB en las 8 últimas semanas;
    5. STUI/HPB insuficientemente controlados mediante el tratamiento médico con bloqueantes alfa.
    6. Presencia de STUI moderados o graves (IPSS >/= 15) en la selección y en la visita basal (después de un periodo de preinclusión con enmascaramiento único de 4 semanas con 0,4 mg de tamsulosina una vez al día);
    7. Volumen prostático >/= 30 ml y </= 70 ml (evaluado mediante ETR);
    8. Qmax < 15 ml/segundo basado en una micción mínima de 125 ml;
    9. Aceptar no usar ningún otro medicamento, autorizado o experimental, para la HPB o la vejiga hiperactiva (VHA) en ningún momento durante el estudio primario;
    10. Aceptar realizar las visitas de seguimiento aun en el caso de suspensión del tratamiento oral antes de que finalice el estudio;
    11. Cumplimiento satisfactorio de la medicación de preinclusión en la visita 2 (basal)
    E.4Principal exclusion criteria
    1. Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment;
    2. Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months;
    3. PSA >/= 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must have been ruled out to the satisfaction of the clinical Investigator by an historical biopsy;
    4. Prostate or bladder cancer, history of pelvic irradiation;
    5. Active or recurrent urinary tract infections (more than 1 episode in the last 12 months);
    6. History of neurogenic bladder or LUTS secondary to neurologic disease;
    7. Use of self-catheterization for urinary retention;
    8. Post-void residual urine volume > 200 mL;
    9. Hematuria which has not been appropriately evaluated to determine safe subject participation;
    10. Renal insufficiency (serum creatinine >2.0 mg/dL);
    11. Liver insufficiency (any liver function tests [LFTs]>2x upper limit of normal [ULN]);
    12. Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c >6% and/or glycosuria;
    13. Any bleeding disorder such as hemophilia, clotting factor(s) deficiency or bleeding diathesis;
    14. Immunosuppressive disorders, such as Human Immunodeficiency (HIV) Virus, Acquired Immune Deficiency Syndrome (AIDS), lymphoproliferative disorders;
    15. Acute or chronic intestinal disease, such as ulcerative colitis, Crohn's disease, acute gastroenteritis in the run-in period; acute painful perianal disorder;
    16. Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, Percutaneous Transluminal Coronary Angioplasty (PTCA), congestive heart failure NYHA Class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
    17. Any condition that would interfere with the subject's ability to provide informed consent, to comply with study instructions, or that might confound the interpretation of the study results, such as dementia, psychosis, manic depressive disorder, post traumatic stress disorder, stroke, Alzheimer's, depression, psychiatric illness, history or current evidence of drug or alcohol abuse within the last 12 months etc.;
    18. Participation in a study of any investigational drug or device within the previous 6 months;
    19. Hypersensitivity or contraindication to tamsulosin use (see Appendix 15.6);
    20. Use of prohibited medications that could endanger subjects performing the intraprostatic injection or that could interfere with the evaluation of study parameters (please refer to Section 6.7);
    21. Men planning to have children in the future;
    22. Any other condition that may interfere with the study or endanger the subject.
    1. Tratamientos prostáticos previos, quirúrgicos o invasivos, como RTUP, TTUM, ATUA, láser o cualquier otro tratamiento mínimamente invasivo;
    2. Prostatitis aguda o crónica o sospecha de prostatitis que incluye dolor crónico, dolor intermitente o sensación anormal en el pene, los testículos, la zona anal o la zona pélvica en los 12 últimos meses;
    3. PSA >/= 10 ng/ml. En caso de que el PSA se encuentre entre 4,0 y 10,0 ng/ml, tiene que haberse descartado un cáncer de próstata, a satisfacción del investigador clínico, mediante una biopsia histórica;
    4. Cáncer de próstata o vejiga, antecedentes de irradiación pélvica;
    5. Infecciones del tracto urinario activas o recurrentes (más de un episodio en los 12 últimos meses);
    6. Antecedentes de vejiga neurógena o STUI secundarios a una enfermedad neurológica;
    7. Uso de autosondaje por retención urinaria;
    8. Volumen de orina residual posmiccional > 200 ml;
    9. Hematuria que no haya sido adecuadamente estudiada para determinar la participación segura del sujeto;
    10. Insuficiencia renal (creatinina sérica > 2,0 mg/dl);
    11. Insuficiencia hepática (cualquier prueba de función hepática [PHF] > 2 x límite superior de normalidad [LSN];
    12. Diabetes mal controlada (de tipo 1 o de tipo 2), determinada por una HbA1c > 6% o glucosuria;
    13. Cualquier trastorno hemorrágico como hemofilia, deficiencia de factor(es) de la coagulación o diátesis hemorrágica;
    14. Trastornos inmunodepresores, tales como el virus de la inmunodeficiencia humana (VIH), el síndrome de inmunodeficiencia adquirida (SIDA), los trastornos linfoproliferativos;
    15. Enfermedad intestinal aguda o crónica, como colitis ulcerosa, enfermedad de Crohn, gastroenteritis aguda en el periodo de preinclusión; trastorno perianal doloroso agudo;
    16. Enfermedad cardiovascular o cerebrovascular inestable (como infarto agudo de miocardio, angina de pecho inestable, derivación aortocoronaria, angioplastia coronaria transluminal percutánea (ACTP); insuficiencia cardiaca congestiva de clase III-IV de la NYHA, accidente cerebrovascular, accidente isquémico transitorio y episodios de arritmia cardiaca que hayan precisado tratamiento en los 6 últimos meses);
    17. Cualquier afección que pueda interferir en la capacidad del sujeto para otorgar el consentimiento informado o para cumplir las instrucciones del estudio, o que pudiera confundir la interpretación de los resultados del estudio, por ejemplo, demencia, psicosis, trastorno maníaco-depresivo, trastorno por estrés postraumático, accidente cerebrovascular, enfermedad de Alzheimer, depresión, enfermedad psiquiátrica, antecedentes de abuso o pruebas actuales de abuso de drogas o alcohol en los 12 últimos meses, etc.;
    18. Participación en un estudio de cualquier medicamento o producto sanitario en investigación en los 6 meses anteriores;
    19. Hipersensibilidad a la tamsulosina o contraindicación para su uso (véase el Apéndice 15.6);
    20. Uso de medicamentos prohibidos que pudieran poner en peligro a los sujetos en caso de someterse a la inyección intraprostática o que pudieran interferir en la evaluación de los parámetros del estudio (consúltese el Apartado 6.7);
    21. Varones que prevén tener hijos en el futuro;
    22. Cualquier otra situación que pueda interferir en el estudio o poner en peligro al sujeto.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) in patients not adequately controlled by medical therapy with alfa blockers, as assessed by a change from baseline in the total score (Questions 1 to 7) of the International Prostate Symptom Score (IPSS).
    Mejorar los síntomas del tracto urinario inferior asociados a hiperplasia benigna prostática (STUI/HPB) en pacientes insuficientemente controlados mediante el tratamiento farmacológico con bloqueantes alfa lo que se evalúa por la variación en la puntuación total (preguntas 1 a 7) de la Escala internacional de síntomas prostáticos (IPSS, International Prostate Symptom Score) respecto a la puntuación basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after randomisation.
    12 meses después de la aleatorización.
    E.5.2Secondary end point(s)
    - Change from baseline in subscores for storage symptoms and voiding symptoms at 12 months;
    - Change from baseline in question 8 of IPSS at 12 months;
    - Response rate by IPSS at 12 months;
    - Time to treatment failure;
    - Change from baseline in BII at 12 months;
    - Patient-rated global assessment of treatment BSW to continue at 12 months (or in case of early termination);
    - Change from baseline in EQ-5D-5L at 12 months (or in case of early termination);
    - Change from baseline in IPSS total score at 1, 3, 6 and 9 months;
    - Change from baseline in subscores for storage symptoms and voiding symptoms at 1, 3, 6 and 9 months,
    - Change from baseline in question 8 of IPSS at, 1,3,6 and 9 months;
    - Response rate by IPSS at 1, 3, 6 and 9 months;
    - Change from baseline in BII at 1, 3, 6, 9 months;
    - Change from baseline in the no. of voids (day/night/24 hours) and min/max/mean voided volume at 12 months;
    - Change from baseline in Maximum Urinary Flow (Qmax) at 3, 6, 9, 12 months (blinded centralized reading);
    - Change from baseline in TRUS assessed prostate volume at 3 and 12 months (or in case of early termination);
    - Percentage of subjects requiring medical therapy, MIST, TURP or surgery for LUTS/BPH and time to treatment failure;
    - Change from baseline in the total score (questions 1 to 7) of the IPSS;
    - Change from baseline in QoL due to urinary symptoms (question 8 of IPSS and BII);
    - Change from baseline in general health-related QoL (EQ-5D-5L);
    - SAEs and episodes of acute urinary retention.
    - Variación en la puntuación total de la IPSS a los 1, 3, 6 y 9 meses con respecto a la situación basal;
    - Variación en las subpuntuaciones de los síntomas de almacenamiento (preguntas 2, 4 y 7) y en los síntomas de vaciamiento (preguntas 1, 3, 5 y 6) a los 1, 3, 6 y 12 meses con respecto a la situación basal;
    - Porcentaje de respuesta mediante IPSS (disminución >/= 25% en comparación con la situación basal) a los 1, 3, 6, 9 y 12 meses;
    - Variación en el número de micciones (diurnas/nocturnas/en 24 horas) y el volumen mínimo/máximo/medio evacuado, evaluados mediante una gráfica de frecuencia y volumen (GFV) durante 3 días, a los 12 meses con respecto a la situación basal;
    - Tiempo transcurrido hasta el fracaso del tratamiento;
    - Variación en la calidad de vida debida a los síntomas urinarios (pregunta 8 de la IPSS) a los 1, 3, 6, 9 y 12 meses con respecto a la situación basal;
    - Variación del Índice de impacto de la HPB (BII, BPH Impact Index) a los 1, 3, 6, 9 y 12 meses con respecto a la situación basal;
    - Variación en el cuestionario EuroQual de 5 dimensiones y 5 niveles (EQ-5D-5L) a los 12 meses (o en caso de finalización prematura) con respecto a la situación basal;
    - Evaluación global calificada por el paciente del beneficio del tratamiento, la satisfacción y la disposición a continuar (BSW, Benefit, Safisfaction and Willingness to continue), a los 12 meses (o en caso de finalización prematura);
    - Variación del flujo urinario máximo (Qmax) a los 3, 6, 9 y 12 meses con respecto al valor basal (lectura centralizada enmascarada);
    - Variación del volumen de la próstata evaluado por ETR a los 3 y 12 meses (o en caso de finalización prematura) con respecto a la situación basal;
    - Porcentaje de sujetos que precisan tratamiento médico, tratamientos quirúrgicos mínimamente invasivos (TQMI), RTUP o cirugía para STUI/HPB y tiempo transcurrido hasta el fracaso del tratamiento;
    - Variación en la puntuación total (preguntas 1 a 7) de la IPSS con respecto a la puntuación basal;
    - Variación en la calidad de vida debida a los síntomas urinarios (pregunta 8 de la IPSS y BII) con respecto a la situación basal;
    - Variación en la CV relacionada con la salud en general (EQ-5D-5L) con respecto a la situación basal;
    - Acontecimientos adversos graves (AAG) y episodios de retención urinaria aguda;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through 12, 18 and 24 months
    A lo largo de 12, 18 y 24 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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Czech Republic
    France
    Germany
    Italy
    Poland
    Portugal
    Russian Federation
    Spain
    United Kingdom
    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
    LVLS
    Última visita del último sujeto participante en el estudio (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 340
    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)
    At the end of the 12-month core period (or in case of premature dicontinuation), subejct will enter in the follow up period and will be treated as needed according to current clinical practice.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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