Clinical Trials Register

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:	Completed
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2008-007087-42

A.3

Full 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.3.2

Name or abbreviated title of the trial where available

CAPRICORN

A.4.1

Sponsor's protocol code number

178-CL-074

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Astellas Pharma Europe B.V.
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	YM178 OCAS tablet 25 mg
D.3.2	Product code	YM178
D.3.4	Pharmaceutical form	Modified-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	YM178
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	YM178 OCAS tablet 50 mg
D.3.2	Product code	YM178
D.3.4	Pharmaceutical form	Modified-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	YM178
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Modified-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Modified-release tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Síntomas de vejiga hiperactiva

Symptoms of overactive bladder

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	84
F.4.2	For a multinational trial
F.4.2.1	In the EEA	700
F.4.2.2	In 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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-06-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-04-27

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