Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35525   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-007087-42
    Sponsor's Protocol Code Number:178-CL-074
    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:2009-04-30
    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 number2008-007087-42
    A.3Full title of the trial
    Estudio de fase III, multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la eficacia y seguridad del agonista beta-3 YM178 (25 mg, una vez al día y 50 mg, una vez al día) en pacientes con síntomas de vejiga hiperactiva.

    A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety
    of the Beta-3 Agonist YM178 (25 mg qd and 50 mg qd) in Subjects with Symptoms of Overactive Bladder
    A.3.2Name or abbreviated title of the trial where available
    CAPRICORN
    A.4.1Sponsor's protocol code number178-CL-074
    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 OCAS tablet 25 mg
    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.3.9.2Current sponsor codeYM178
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 OCAS tablet 50 mg
    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.3.9.2Current sponsor codeYM178
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de 25 y 50 mg de YM178 una vez al día frente a placebo en el tratamiento de pacientes con síntomas de vejiga hiperactiva.

    To assess the efficacy of YM178 25 mg qd and YM178 50 mg qd against placebo in the treatment of subjects with symptoms of overactive bladder.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad y tolerabilidad de 25 y 50 mg de YM178 una vez al día frente a placebo en el tratamiento de pacientes con síntomas de vejiga hiperactiva.

    To assess the safety and tolerability of YM178 25 mg qd and YM178 50 mg qd against placebo 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
    Los pacientes deberán cumplir todos los siguientes criterios para ser incluidos en el estudio:

    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 (p. ej., en los centros de EE. UU., autorización HIPAA) 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
    1. El paciente debe presentar una frecuencia de micción media ?8 veces cada 24 horas durante el periodo de 3 días de registro del diario miccional.
    2. El paciente debe presentar al menos 3 episodios de urgencia (grado 3 ó 4) con o sin incontinencia durante el periodo de 3 días de registro del diario miccional.
    3. El paciente sigue reuniendo todos los criterios de inclusión y ninguno de los criterios de exclusión de la visita 1.
    E.4Principal exclusion criteria
    Criterios de exclusión
    Los pacientes serán excluidos si se cumplen alguno de los siguientes criterios:

    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 (ß-HCG sérica) debe ser negativa en la visita 1 en las mujeres en edad fértil.
    2. 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).
    3. Pacientes con catéteres o que requieren cateterización intermitente.
    4. Pacientes con neuropatía diabética.
    5. Pacientes con evidencia de infección del tracto urinario, inflamación crónica como la cistitis intersticial, cálculos vesicales, radioterapia pélvica previa o patología maligna previa o actual de los órganos pélvicos.
    6. 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).
    7. Pacientes que reciban medicamentos para el tratamiento de 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.
    8. Pacientes que padecen hipertensión severa, definida como una media de presión arterial sistólica en posición sentada ? 180 mm Hg y/o una media de presión arterial diastólica en posición sentada ? 110 mm Hg (véase sección 5.4.1. Constantes vitales).
    9. Pacientes con hipersensibilidad conocida o sospechada a YM178, otros agonistas ß-3 o cualquiera de los excipientes inactivos.
    10. Pacientes con cualquier enfermedad clínicamente significativa que, en opinión del investigador, les incapacite para participar en el estudio.
    11. Pacientes que hayan participado en algún estudio clínico en los 30 días (90 días en el Reino Unido) previos a la visita 1/selección, o que hayan participado en cualquier estudio previo con YM178.
    12. Pacientes que sean empleados del grupo Astellas, terceras partes relacionadas con el estudio o el centro de estudio.

    Criterios de exclusión en la visita 2/basal
    1. Pacientes con un volumen miccional diario total medio > 3.000 mL, según los registros del diario miccional de 3 días.
    2. Pacientes con un nivel de creatinina sérica > 150 µmol/L o de AST o ALT > 2 veces el límite superior de la normalidad (LSN), o de Gamma-GT > 3 veces el LSN, según la valoración de las muestras de la visita 1, siendo considerado clínicamente significativo por el investigador.
    3. Pacientes que padecen hipertensión severa, definida como una media de presión arterial sistólica en posición sentada ?180 mm Hg y/o una media de presión arterial diastólica en posición sentada ?110 mm Hg (véase sección 5.4.1. Constantes vitales).
    4. Pacientes con un ECG alterado que, en opinión del investigador, les incapacite para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Variables de eficacia co-principales:
    - Variación respecto a la visita basal en el número medio de micciones/24 horas, según un diario miccional de 3 días.
    - Variación respecto a la visita basal en el número medio de episodios de incontinencia/24 horas, según un diario miccional de 3 días.


    Co-primary efficacy variables:
    - Change from baseline in mean number of micturitions/24 h based on a 3-day micturition diary,
    - Change from baseline in mean number of incontinence episodes/24 h based on a 3-day micturition diary.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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 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 state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1300
    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 Decision2009-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA