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    Summary
    EudraCT Number:2007-001452-39
    Sponsor's Protocol Code Number:178-CL-049
    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:2008-03-14
    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 number2007-001452-39
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble-ciego, de grupos paralelos, controlado con tratamiento activo, para evaluar la seguridad y eficacia a largo plazo del agonista beta-3 YM178 (50 mg, una vez al día y 100 mg, una vez al día) en pacientes con síntomas de vejiga hiperactiva

    A Randomized, Double-Blind, Parallel Group, Active Controlled, Multicenter Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist YM178 (50 mg qd and 100 mg qd) in Subjects with Symtpoms of Overactive Bladder
    A.3.2Name or abbreviated title of the trial where available
    TAURUS
    A.4.1Sponsor's protocol code number178-CL-049
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameYM178
    D.3.2Product code YM178
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmirabegron
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Detrol LA 4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia & Upjohn Company
    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.3.4Pharmaceutical form Prolonged-release capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameYM178
    D.3.2Product code YM178
    D.3.4Pharmaceutical form Modified-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmirabegron
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboModified-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 capsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboModified-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
    Síntomas de vejiga hiperactiva

    Symptoms of overactive bladder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la seguridad y tolerabilidad del tratamiento a largo plazo con YM178 (50mg y 100 mg una vez al día) en pacientes con síntomas de vejiga hiperactiva.

    To assess the safety and tolerability of long-term treatment with YM178 (50 mg qd and 100 mg qd) in subjects with symptoms of overactive bladder
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia del tratamiento a largo plazo con YM178 (50mg y 100 mg una vez al día) en pacientes con síntomas de vejiga hiperactiva.
    Comparar la seguridad y eficacia del tratamiento a largo plazo de YM178 frente a 4 mg de tolterodina LP (de liberación prolongada) una vez al día en el tratamiento de pacientes con síntomas de vejiga hiperactiva.

    To assess the efficacy of long-term treatment with YM178 (50 mg qd and 100 mg qd) in subjects with symptoms of overactive bladder.
    To compare the long-term safety and efficacy of YM178 with tolterodine ER 4 mg qd in the treatment of subjects with symptoms of overactive bladder.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios de inclusión en la visita 1/selección
    1. Hombre o mujer de edad ≥18 años.
    2. Obtención por escrito del Consentimiento Informado aprobado por el Consejo Institucional de Revisión (IRB)/Comité Ético de Investigación Clínica (CEIC) y privacidad según las normativas nacionales correspondientes, ya sea del propio sujeto o de su representante legal autorizado (antes de cualquier procedimiento relacionado con el estudio; incluida la interrupción de los medicamentos prohibidos, si procede).
    3. El paciente es capaz y está dispuesto a completar correctamente el diario miccional y los cuestionarios.
    4. Paciente con síntomas de vejiga hiperactiva (urgencia y frecuencia urinaria, con o sin incontinencia) durante ≥3 meses.
    Criterios de inclusión en la visita 2/basal
    5. El paciente presenta una frecuencia de micción media ≥8 veces cada 24 horas durante el periodo de 3 días de registro del diario miccional.
    6. El paciente debe presentar al menos 3 episodios de urgencia (grado 3 o 4) con o sin incontinencia durante el periodo de 3 días de registro del diario miccional.
    7. El paciente sigue reuniendo todos los criterios de inclusión y ninguno de los criterios de exclusión de la visita 1.

    Reference is made to the protocol for inclusion criteria
    E.4Principal exclusion criteria
    Criterios de exclusión en la visita 1/selección
    1. Mujeres en periodo de lactancia, embarazadas; o que deseen quedarse embarazadas durante el estudio o mujeres en edad fértil, sexualmente activas y que no utilicen un método anticonceptivo fiable (métodos con una tasa de fallo <1% anual, como los implantes hormonales, los anticonceptivos inyectables, los anticonceptivos orales de tipo combinación, la anticoncepción intrauterina limitada a los dispositivos intrauterinos hormonales, la abstinencia sexual o la vasectomía de la pareja). La prueba de embarazo (beta-HCG sérica) debe ser negativa en la visita 1 en mujeres en edad fértil.
    2. Pacientes con una obstrucción clínicamente significativa del flujo de salida vesical con riesgo de retención urinaria (a juicio del investigador).
    3. Pacientes con incontinencia de esfuerzo significativa o incontinencia mixta (esfuerzo/urgencia) en la que el esfuerzo es el factor predominante, según determine el investigador (en el caso de las mujeres, confirmado mediante una prueba de provocación por tos, Apéndice 4).
    4. Pacientes con catéteres o que requieren cateterización intermitente.
    5. Pacientes con neuropatía diabética.
    6. Pacientes con evidencia de infección sintomática del tracto urinario, inflamación crónica como la cistitis intersticial, cálculos vesicales, radioterapia pélvica previa o patología maligna previa o actual de los órganos pélvicos.
    7. Pacientes con glaucoma de ángulo estrecho no controlado, retención urinaria o gástrica, colitis ulcerosa grave, megacolon tóxico, miastenia gravis o cualquier otra enfermedad que en opinión del investigador contraindique el uso de anticolinérgicos.
    8. Pacientes en tratamiento no farmacológico, incluyendo terapia de electroestimulación (pueden seguir realizándose programas de entrenamiento vesical o ejercicios del suelo pélvico que hayan comenzado más de 30 días antes del inicio del estudio).
    9. Pacientes que reciban medicamentos con la intención de tratar la VH o alguno de los medicamentos prohibidos que se recogen en el Apéndice 1, Parte A. Los pacientes serán excluidos si utilizan los medicamentos restringidos (Apéndice 1, Parte B) y no cumplen las condiciones especificadas en el Apéndice 1, Parte B.
    10. Pacientes con hipersensibilidad conocida o sospechada a tolterodina, otros anticolinérgicos, YM178, otros agonistas de los receptores β-AR, lactosa o cualquier otro de los excipientes inactivos.
    11. Pacientes con cualquier enfermedad clínicamente significativa que, en opinión del investigador, les incapacite para participar en el estudio.
    12. Pacientes que hayan sido tratados con cualquier fármaco en investigación en los 30 días (90 días en el Reino Unido) antes de la visita 1/selección para todos los estudios excepto el 178-CL-046.
    13. Pacientes que sean empleados del grupo Astellas, terceras partes relacionadas con el estudio o el centro del estudio.

    Criterios de exclusión en la visita 2/basal
    14. Pacientes con un volumen miccional diario total medio >3.000 mL, según los registros del diario miccional de 3 días.
    15. Pacientes que, en opinión del investigador, presenten aumentos clínicamente significativos de los parámetros analíticos según las muestras de la visita 1 (p. ej., creatinina sérica >150 micromol/L, AST y/o ALT >2 veces el límite superior de la normalidad (LSN), o gamma-GT >3 veces el LSN).
    16. Pacientes con un ECG alterado que, en opinión del investigador, les incapacite para participar en el estudio.

    Reference is made to the protocol for exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Variable Principal
    -Incidencia y gravedad de las reacciones adversas.
    Variables secundarias de seguridad
    · Constantes vitals: Pulso y tensión sistólica y diastólica en posición sentada.
    · Pruebas de laboratorio: hematología, bioquímica y análisis de orina (tira reactiva).
    · Exploración Física
    · Parámetros de ECG
    Variables de eficacia
    · Variación respecto a la visita basal en el número medio de micciones/24h.
    · Variación respecto a la visita basal en el número medio de episodios de incontinencia/24h.
    · Variación respecto a la visita basal en el volumen medio evacuado por micción.
    · Variación respecto a la visita basal en el número medio de episodios de incontinencia de urgencia/24h.
    · Variación respecto a la visita basal en el número medio de episodios de urgencia (grado 3 y/o 4)/24h.
    · Variación respecto a la visita basal en el grado medio de urgencia.
    · Variación respecto a la visita basal en las puntuaciones de molestias sintomáticas y calidad de vida relacionada con la salud, según el cuestionario OAB-q.
    · Variación respecto a la visita basal en el número de absorbentes utilizados/24h.
    · Variación respecto a la visita basal en las puntuaciones del cuestionario sobre la productividad laboral y la reducción de la actividad; Problema de salud específico WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem).
    · Variación respecto a la visita basal en las puntuaciones del cuestionario de salud EQ5D (European Quality of Life-5 Dimensions)
    · Variación respecto a la visita basal en percepción del paciente de su codición vesical (PPCV).
    · Variación respecto a la visita basal en la escala visual analógica de satisfacción del paciente con el tratamiento (EVA-ST).
    · Variación respecto a la visita basal en el número de visitas médicas por el problema vesical del paciente (están excluidas las visitas relacionadas con el estudio).
    · Variación respecto a la visita basal en el número medio de episodios de nocturia/24h.

    Primary safety variable:
    • Incidence and severity of adverse events.
    Secondary safety variables:
    • Vital signs: sitting systolic and diastolic blood pressure and pulse rate.
    • Laboratory tests: hematology, biochemistry, urinalysis (dipstick method).
    • Physical examination.
    • ECG parameters.
    Efficacy variables:
    • Change from baseline in mean number of micturitions/24h
    • Change from baseline in mean number of incontinence episodes/24h
    • Change from baseline in mean volume voided per micturition
    • Change from baseline in mean number of urgency incontinence episodes/24h
    • Change from baseline in mean number of urgency episodes (grade 3 and/or 4) /24h
    • Change from baseline in mean level of urgency
    • Change from baseline in symptom bother and health related quality of life scores as
    assessed by OAB-q questionnaire
    • Change from baseline in the mean number of pads used / 24h
    • Change from baseline in scores as assessed by Work Productivity and Activity
    Impairment: Specific Health Problem (WPAI:SHP)
    • Change from baseline in scores as assessed by European Quality of Life-5 Dimensions
    (EQ-5D) questionnaire
    • Change from baseline in Patient Perception of Bladder Condition
    • Change from baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
    • Change from baseline in the number of physician visits for the subject’s bladder
    condition (excluding study related visits)
    • Change from baseline in mean number of nocturia episodes/24h.
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA230
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months6
    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 months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1660
    F.4.2.2In the whole clinical trial 2500
    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 Decision2008-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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