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    Summary
    EudraCT Number:2015-004036-36
    Sponsor's Protocol Code Number:178-MA-1008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-29
    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 number2015-004036-36
    A.3Full title of the trial
    A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-
    Center Study to Evaluate the Efficacy, Safety, and Tolerability of
    Mirabegron in Men with Overactive Bladder (OAB) Symptoms
    While Taking the Alpha Blocker Tamsulosin Hydrochloride for
    Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic
    Hyperplasia (BPH)
    Estudio de fase IV, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia, seguridad y tolerabilidad de mirabegron en varones con síntomas de vejiga hiperactiva (VH), en tratamiento con el alfa-bloqueante hidrocloruro de tamsulosina para los síntomas del trato urinario inferior (STUI) debidos a hiperplasia benigna de próstata (HBP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of combined use of tamsulosin and mirabegron in men who have enlarged prostate and an overactive bladder
    Estudio para evaluar la eficacia y seguridad de combinar el uso de tamsulosina y mirabegron en hombres con agrandamiento de la próstata y vejiga hiperactiva
    A.3.2Name or abbreviated title of the trial where available
    PLUS
    PLUS
    A.4.1Sponsor's protocol code number178-MA-1008
    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 SponsorAstellas Pharma Global development, 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 supportAstellas Pharma Global Development, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)715455878
    B.5.5Fax number+31(0)715455224
    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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBetmiga
    D.3.2Product code PRD746368
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBetmiga
    D.3.2Product code PRD746368
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release 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
    Over active bladder (OAB) in men with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
    Vejiga hiperactiva (VH) en hombres con Síntomas del Tracto Urinario Inferior (STUI) debidos a Hiperplasia Benigna de Próstata (HBP)
    E.1.1.1Medical condition in easily understood language
    Over active bladder in men who also have an enlarged prostate with voiding problems
    Vejiga hiperactiva en hombres con agrandamiento de la próstata y trastornos de la micción.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10046543
    E.1.2Term Urinary incontinence
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the efficacy of mirabegron versus placebo in men with OAB symptoms while taking tamsulosin hydrochloride for LUTS due to BPH.
    Estudiar la eficacia de mirabegrón frente a placebo en varones con síntomas de VH que están tomando al mismo tiempo hidrocloruro de tamsulosina para los STUI asociados a la HBP.
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of mirabegron versus placebo in men with OAB symptoms while
    taking tamsulosin hydrochloride for LUTS due to BPH.
    Evaluar la seguridad y tolerabilidad de mirabegrón frente a placebo en varones con síntomas de VH que están recibiendo al mismo tiempo hidrocloruro de tamsulosina para los STUI asociados a la HBP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for US sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Men ≥40 years of age with history of OAB symptoms (urinary frequency and urgency with or without incontinence) while taking tamsulosin hydrochloride 0.4 mg daily for at least 2 months to treat LUTS due to BPH.
    3. Subject has symptoms of OAB (frequency of ≥8 micturitions per day and urgency episodes of ≥2 per day) for ≥3 months prior to Screening.
    4. Subject has an IPSS score ≥8.
    5. Subject has Prostate-Specific Antigen (PSA) < 4 ng/mL.
    6. Subject is willing and able to complete the 3-day diary (including urine volumes, vital sign measurements), and Quality of Life questionnaires.
    7. Subject and their spouses/partners who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from Screening and continue throughout the study and for 30 days after the final study drug administration. In addition, sperm donation will not be allowed throughout the study and for 30 days after the final study drug administration.
    8. Subject agrees not to participate in another interventional study while on treatment.
    Inclusion Criteria assessed at Visit 2 (Baseline) based on the 3-day diary:
    9. Subject continues to meet all inclusion criteria of Visit 1 (Screening).
    10. Subject must experience an average of 8 or more micturitions per day over the 3-day diary period.
    11. Subject must experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-day diary period.
    Criterios de inclusión evaluados en la visita 1 (selección):
    1. Obtención por escrito, ya sea del propio sujeto o de su representante legal autorizado, del documento de privacidad y del consentimiento informado aprobado por el Comité de Ética de la Investigación con Medicamentos (CEIm) conforme a lo establecido en la legislación del país correspondiente (p. ej., en los centros de EE. UU., autorización HIPAA). La obtención de estos documentos será previa a la realización de cualquier procedimiento relacionado con el estudio, incluida la interrupción de los medicamentos prohibidos, si procede.
    2. Varones de al menos 40 años de edad con historial de síntomas de VH (frecuencia y urgencia con o sin incontinencia) que toman hidrocloruro de tamsulosina 0,4 mg diariamente desde hace al menos 2 meses para tratar los STUI asociados a la HBP.
    3. Pacientes con síntomas de VH (frecuencia de al menos 8 micciones al día y al menos 2 episodios de urgencia al día) durante 3 ó más meses antes de la selección.
    4.Pacientes con una puntuación IPSS de al menos 8.
    5. Pacientes con un valor de PSA (antígeno prostático específico) menor de 4 ng/mL.
    6. Pacientes dispuestos y capaces de completar el diario de 3 días (incluyendo volúmenes urinarios y constantes vitales) y los cuestionarios de calidad de vida.
    7. Los pacientes y sus cónyuges/parejas en edad fértil deberán utilizar un método anticonceptivo altamente eficaz; esto incluye el uso continuado de métodos anticonceptivos hormonales orales, inyectados o implantados, o la colocación de un DIU o SIU. La anticoncepción deberá utilizarse desde la selección y mantenerse durante todo el estudio y los 30 días siguientes a la administración final del fármaco del estudio. Además, no se podrá donar esperma durante el periodo del estudio y los 30 días siguientes a la administración final del fármaco del estudio.
    8. Los pacientes deberán mostrar su conformidad a no participar en ningún otro estudio intervencionista mientras reciben el tratamiento.
    Criterios de inclusión evaluados en la visita 2 (basal) en función de los datos recogidos en el diario de 3 días:
    9. Los pacientes deben seguir cumpliendo todos los criterios de inclusión de la visita 1 (selección).
    10. Los pacientes deben haber experimentado un promedio de 8 o más micciones diarias a lo largo del periodo de 3 días de registro del diario.
    11. Los pacientes deben haber experimentado un promedio de 2 o más episodios de urgencia diarios (grado 3 o 4) a lo largo del periodo de 3 días de registro del diario.
    E.4Principal exclusion criteria
    1. Subject has PVR >200 mL.
    2. Subject has Qmax <5.0 mL/second with a minimum voided volume of 125 mL.
    3. Subject has hematuria >3 rbc/hpf that has not been fully evaluated.
    4. Subject has evidence of UTI.
    5. Subject has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson’s etc.).
    6. Subject has diabetic neuropathy.
    7. Previous open, robotic or minimally invasive prostate surgery (including transurethral
    procedures). Planned (scheduled) pelvic or prostate surgery planned during the study
    period.
    8. Planned (scheduled) cataract surgery during the study period.
    9. Subject with significant stress incontinence as determined by the Investigator.
    10. Subject with clinically significant bladder outlet obstruction as determined by the
    Investigator.
    11. Subject has an indwelling catheter or practices intermittent self-catheterization.
    12. Subject has experienced 3 or more episodes of recurrent urinary tract infection within the last 12 months.
    13. Subject has a symptomatic urinary tract infection, prostatitis, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder, prostate and rectum; organs of the lower gastrointestinal tract are not necessarily considered pelvic organs as the distal ascending colon, the full transverse colon and proximal portion of the descending colon are in the abdomen).
    14. Subject has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
    15. Subject has ever received electro-stimulation therapy for OAB (e.g. sacral nerve stimulation or Percutaneous Tibial Nerve Stimulation [PTNS]).
    16. Subject began or has changed a bladder training program or pelvic floor exercises less than 30 days prior to Screening.
    17. Subject has postural hypotension or syncope or postural orthostatic tachycardia.
    18. Subject has moderate or severe hepatic impairment defined as Child-Pugh Class B or C.
    19. Subject has severe renal impairment defined as estimated creatinine clearance less than 29 mL/min/1.73m2 as determined by central laboratory calculation of eGFR. A subject with End Stage Renal Disease (ESRD) or undergoing dialysis is also not a candidate for the study.
    20. Subject has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg.
    21. Subjects has baseline resting pulse rate <60 BPM or >90 BPM.
    22. Subject has evidence of QT prolongation on Screening (Visit 1) or Baseline (Visit 2) electrocardiogram (ECG) defined as QTcF >450 msec.
    23. Subject has any clinically significant ECG abnormality, as determined by the Investigator.
    24. Subject has AST or ALT >2x upper limit of normal (ULN), or y-GT >3x ULN and considered clinically significant by the Investigator.
    25. Subject has a hypersensitivity to any components of mirabegron, tamsulosin hydrochloride, or any of the inactive ingredients.
    26. Subject has a history of angioedema.
    27. Subject has any clinically significant condition, which in the opinion of the Investigator makes the subject unsuitable for study participation.
    28. Subject has been treated with an experimental device within 28 days or received an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to Screening.
    29. Subject has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
    30. Subject has ongoing alcohol and/or drug abuse.
    31. Subject is using prohibited medications defined in Appendix 1, Part A within 30 days prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
    32. Subject has stopped, started or changed the dose of a restricted medication (defined in Appendix 1, Part B) within 30 days prior to Screening (Visit 1) through Follow-Up Phone Call (Visit 6).
    33. Subject has participated in an interventional trial within 30 days prior to Screening (Visit 1).
    34. Subject is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.
    35. Subject has previously received mirabegron in the 6 months prior to Screening (Visit 1).
    Exclusion Criteria assessed at Visit 2 (Baseline):
    36. Subject was non-compliant during the 4-week tamsulosin hydrochloride run-in period, defined as taking less than 80% or greater than 120% of study medication.
    37. Subject had an average total daily urine volume >3000mL as recorded in the 3-day diary.
    1. Pacientes con RPM >200 mL. 2. Pacientes con Qmáx <5,0 mL/seg. y volumen evacuado mínimo de 125 mL. 3. Pacientes con hematuria >3 hem./campo de alta resolución, no evaluada completamente. 4. Pacientes con evidencia de ITU. 5. Pacientes con vejiga neurógena (lesión de la médula espinal, esclerosis múltiple, Parkinson, etc.). 6. Pacientes con neuropatía diabética. 7. Cirugía prostática previa (abierta, robótica o mínimamente invasiva, incluyendo procedimientos transuretrales). Cirugía prostática o pélvica prevista (programada) durante el estudio. 8. Cirugía de cataratas prevista (programada) durante el estudio. 9. Pacientes con incontinencia de esfuerzo significativa a criterio del investigador. 10. Pacientes con obstrucción del tracto de salida vesical clínicamente significativa a criterio del investigador. 11. Pacientes con catéteres o que necesiten cateterización intermitente. 12. Pacientes que hayan presentado 3 o más episodios de ITU recurrentes en los últimos 12 meses. 13. Pacientes con infección sintomática del tracto urinario, prostatitis, inflamación crónica, tal como cistitis intersticial, cálculos en la vejiga, radioterapia pélvica previa o patología maligna previa o actual en los órganos pélvicos (es decir, dentro de los límites de la pelvis, incluyendo la vejiga, la próstata y el recto; los órganos del tracto gastrointestinal inferior no se consideran necesariamente órganos pélvicos, ya que el colon ascendente distal, todo el colon transverso y la porción proximal del colon descendente están en el abdomen). 14. Pacientes que hayan recibido alguna inyección intravesical con toxina botulínica, resiniferatoxina o capsaicina en los últimos 12 meses. 15. Pacientes que hayan recibido alguna vez terapia de electroestimulación para la VH (por ejemplo, estimulación del nervio sacro o estimulación percutánea del nervio tibial [EPNT]). 16. Pacientes que hayan comenzado o hayan cambiado su programa de entrenamiento vesical o de ejercicios del suelo pélvico en los 30 días previos a la selección. 17. Pacientes con hipotensión postural, síncope o taquicardia ortostática postural. 18. Pacientes con alteración hepática moderada o grave (definida como clase B o C de Child-Pugh). 19. Pacientes con insuficiencia renal grave, definida como un aclaramiento de creatinina estimado <29 mL/min/1,73 m2 determinado mediante cálculo de la TFGe en el laboratorio central. Los pacientes con enfermedad renal terminal (ERT) o en diálisis no serán candidatos para este estudio. 20. Pacientes con hipertensión grave no controlada (definida por PAS de 180 mmHg o más y/o PAD de 110 mm Hg o más en sedestación). 21. Pacientes con frecuencia del pulso basal en reposo <60 lpm o >90 lpm. 22. Pacientes con evidencia de prolongación del QT en el ECG de visita 1 o de visita 2, definida como un intervalo QTcF >450 ms. 23. Pacientes con cualquier alteración del ECG clínicamente significativa, a criterio del investigador. 24. Pacientes con un nivel de AST o ALT >2 veces el LSN o con un nivel de GGT >3 veces el LSN y clínicamente significativo a criterio del investigador. 25. Pacientes con hipersensibilidad a los componentes de mirabegrón, hidrocloruro de tamsulosina o a cualquiera de los excipientes inactivos. 26. Pacientes con historial de angioedema. 27. Pacientes con cualquier enfermedad clínicamente significativa que, en opinión del investigador, les incapacite para participar en el estudio. 28. Pacientes que hayan sido tratados con un dispositivo en investigación en los últimos 28 días o que hayan recibido un fármaco en investigación en los últimos 28 días o 5 semividas (lo que sea más largo) antes de la selección. 29. Pacientes con patología maligna concomitante o historial de patología maligna (en los últimos 5 años), a excepción del carcinoma de piel espinocelular o basocelular no metastásico tratado con éxito. 30. Pacientes con historial de abuso continuado de alcohol y/o drogas. 31. Pacientes que hayan tomado medicamentos prohibidos que se indican en el Apéndice 1, Parte A, desde los 30 días previos a la visita 1 hasta la visita 6. 32. Pacientes que hayan interrumpido, iniciado o cambiado la dosis de un medicamento restringido (según se define en el Apéndice 1, Parte B) desde los 30 días previos a la visita 1 hasta la visita 6. 33. Pacientes que hayan participado en un ensayo clínico intervencionista en los 30 días previos a la visita 1. 34. Personas involucradas en la realización del estudio como empleados del grupo Astellas, terceras partes relacionadas con el estudio o el equipo del centro de estudio. 35. Pacientes que hayan recibido mirabegrón en los 6 meses previos a la visita 1.Criterios de exclusión evaluados en la visita 2: 36. Falta de cumplimiento del paciente durante el periodo de preinclusión de 4 semanas con hidrocloruro de tamsulosina (definido por la toma de menos del 80 % o más del 120 % de la medicación del estudio). 37. Pacientes con un volumen miccional diario medio >3000 mL (según el diario miccional de 3 días).
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline (Visit 2) to Week 12/ End of Treatment (Visit 5) in mean number of micturitions per day based on a 3-day diary.
    Cambio desde la visita basal (visita 2) hasta la semana 12/final del tratamiento (visita 5) en el número medio de micciones diarias, según el diario de 3 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean volume voided per micturition.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of incontinence episodes per day (FAS-I).
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of urgency episodes (grade 3 and 4) per day.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in IPSS total score and subscales (Voiding, Storage, and Quality of Life).
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of urgency incontinence episodes per day (FAS-I).
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in Symptom Bother Total Health Related Quality of Life and subscale
    (coping, concern, sleep, social interaction, and symptom bother) scores as assessed by OAB-q questionnaire.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) as assessed by EQ-5D-5L questionnaire.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in PPBC.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in Total Urgency and Frequency Score (TUFS) using PPIUS (Grade 3 or 4).
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in mean number of nocturia episodes per day.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in TS-VAS scores.
    ● Change from Baseline (Visit 2) to Week 4, Week 8, and Week 12/End of Treatment (Visit 5) in the number of protective garments (e.g. absorbent pads, incontinence
    briefs, disposable underwear).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en el volumen medio evacuado por micción.
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en el número medio de episodios diarios de incontinencia (SCA-I).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en el número medio de episodios diarios de urgencia (grado 3 y 4).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en la puntuación de la escala IPSS total y sus subescalas (vaciado, llenado y calidad de vida).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en el número medio de episodios diarios de incontinencia de urgencia (SCA-I).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en la puntuación de la escala de calidad de vida relacionada con la salud y las molestias sintomáticas y en las subescalas del cuestionario OAB-q (afrontamiento, preocupación, sueño, interacción social y molestia sintomática).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) evaluado por el cuestionario EQ-5D-5L.
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en la escala PPBC.
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en la puntuación total de urgencia y frecuencia (TUFS) utilizando la escala PPIUS (grado 3 o 4).
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en el número medio de episodios diarios de nocturia.
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en las puntuaciones de la escala EVA-ST.
    • Cambio desde la visita basal (visita 2) hasta la semana 4, la semana 8 y la semana 12/final del tratamiento (visita 5) en el número medio de prendas protectoras utilizadas (p. ej., absorbentes, pañales para adultos o ropa interior desechable).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, 8 and 12
    Semana 4, 8 y 12
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    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
    The end of trial in all participating countries is defined as the Last Subject’s Last Visit.
    El Final del ensayo en todos los países participantes se define como la última visita del último paciente.
    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 months0
    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 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.1.1.1In 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: 439
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 878
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 659
    F.4.2.2In the whole clinical trial 1317
    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)
    After study is ended, standard clinical practises apply.
    Tras la finalización del estudio, se aplicará la práctica clínica habitual.
    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 Decision2016-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-11
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