Clinical Trials Register

Summary
EudraCT Number:	2007-001870-95
Sponsor's Protocol Code Number:	11984A
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:	2008-02-14
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2007-001870-95

A.3

Full title of the trial

Estudio aleatorizado, doble ciego, de grupos paralelos, dosis fija, controlado con placebo, con duloxetina como fármaco de referencia, que evalúa la eficacia y seguridad de tres dosis de Lu AA21004 en el tratamiento agudo del trastorno depresivo mayor

A.3.2

Name or abbreviated title of the trial where available

No aplica

A.4.1

Sponsor's protocol code number

11984A

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

No aplica

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	H. Lundbeck A/S
B.1.3.4	Country	Denmark
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	Lu AA21004
D.3.2	Product code	Not applicable
D.3.4	Pharmaceutical form	Capsule, hard
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.3.8	INN - Proposed INN	NA
D.3.9.2	Current sponsor code	Lu AA21004
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	2.5
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	Comparator
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	Yes
D.2.1.1.1	Trade name	Cymbalta 30 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	NA
D.3.2	Product code	Not applicable
D.3.4	Pharmaceutical form	Capsule, hard
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.3.8	INN - Proposed INN	Duloxetine hydrochloride
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	30
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Cymbalta 60 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Not applicable
D.3.2	Product code	Not applicable
D.3.4	Pharmaceutical form	Capsule, hard
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.3.8	INN - Proposed INN	Duloxetine hydrochloride
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	60
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: 4
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	Lu AA21004
D.3.2	Product code	Not applicable
D.3.4	Pharmaceutical form	Capsule, hard
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.3.8	INN - Proposed INN	NA
D.3.9.2	Current sponsor code	Lu AA21004
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	5
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: 5
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	Lu AA21004
D.3.2	Product code	Not applicable
D.3.4	Pharmaceutical form	Capsule, hard
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.3.8	INN - Proposed INN	NA
D.3.9.2	Current sponsor code	Lu AA21004
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	10
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	Capsule, hard
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

Trastorno Depresivo Mayor

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10025453
E.1.2	Term	Major depressive disorder NOS

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal del estudio es evaluar la eficacia de tres dosis de Lu AA21004 (2,5mg, 5 mg, o 10 mg día) versus placebo a las ocho semanas de tratamiento.

E.2.2

Secondary objectives of the trial

Evaluar:
-seguridad y tolerabilidad de Lu AA21004 comparado con placebo durante el curso de tto
-eficacia de Lu AA21004 comparada con placebo durante las 8 semanas de tto doble ciego
-proporción de pacientes que responden al tto con LuAA21004 en la semana 8 comparado con placebo
-proporción de pacientes que están en remisión después de ocho semanas de tto con Lu AA21004 comparado con placebo
-eficacia de Lu AA21004 comparada con placebo a la semana de tto
-proporción de pacientes que presentan una respuesta sostenida después de una semana de tto con Lu AA21004 comparado con placebo
-efecto de Lu AA21004 sobre la fatiga evaluada según la escala de gravedad de la fatiga (FSS)
-eficacia y seguridad de duloxetina versus placebo sobre los mismos parámetros que se mencionan para Lu AA21004
-efecto de Lu AA21004 en la calidad de vida relacionada con salud, la incapacidad y la utilización de recursos sanitarios
-farmacocinética de Lu AA21004 y metabolitos Lu AA34443 y Lu AA39835

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Podrá incluirse en este estudio a los pacientes que cumplan todos los criterios siguientes, tanto en la visita de Selección como en la visita Basal:
1. El paciente es capaz de leer y entender la Hoja de información al Paciente.
2. El paciente ha firmado el Formulario de Consentimiento Informado. No puede realizarse ningún procedimiento específico del estudio antes de que el paciente haya firmado dicho formulario.
3. El paciente sufre un episodio depresivo mayor (EDM) como diagnóstico principal de acuerdo con los criterios DSM-IV-TR (código de clasificación 296.xx).
4. La duración informada del EDM en curso es de al menos 3 meses.
5. El paciente tiene una puntuación total MADRS >26.
6.El paciente es, hombre o mujer, de edad comprendida entre 18 y 75 años (ambas incluidas).
7. Las pacientes deberán:
- no quedarse embarazadas durante el estudio, ASÍ COMO
- utilizar un procedimiento anticonceptivo adecuado (un procedimiento anticonceptivo adecuado se define como el uso de anticonceptivos orales/sistémicos, dispositivos intrauterinos, diafragma en combinación con espermicida, o preservativo para la pareja masculina asociado con espermicida), O BIEN
- haber tenido la última menstruación natural al menos 24 meses antes de la visita Basal O BIEN
- ser estéril por cirugía antes de la visita Basal, O BIEN
- haber sufrido histerectomía antes de la visita Basal, O BIEN
- no ser sexualmente activa con hombres

E.4

Principal exclusion criteria

No podrán incluirse en este estudio a los pacientes que cumplan alguno de los criterios siguientes en la visita de Selección o en la visita Basal:
1. El paciente sufre una o más de las afecciones siguientes:
- Cualquier trastorno psiquiátrico en curso diferente al MDD, de acuerdo con la definición DSM-IV-TR (valorado con MINI).
- Presencia o antecedentes de: episodios maníacos o hipomaníacos, esquizofrenia o cualquier otro trastorno psicótico tal como depresión mayor con características psicóticas, retardo mental, trastornos mentales orgánicos o trastornos mentales debidos a una enfermedad generalizada tal como se define en DSM-IV-TR.
- Adicción a cualquier sustancia (excepto cafeína y nicotina) con los 6 meses previos, tal como se define en DSM-IV-TR.
- Presencia o antecedentes trastornos neurológicos clínicamente significativos (incluso epilepsia).
- Trastornos neurodegenerativos (enfermedad de Alzheimer, enfermedad de Parkinson, esclerosis múltiple, enfermedad de Huntington, etc.).
- Cualquier trastorno del eje II que pueda comprometer el estudio.
2. El sujeto, según el criterio del investigador, presenta riesgo significativo de suicidio de acuerdo con el criterio del investigador, o tiene una puntuación >5 en el ítem 10 (ideas suicidas) de la MADRS, o ha hecho algún intento de suicidio en los 6 meses previos.
3. El investigador considera que los síntomas depresivos en curso del paciente han sido resistentes a dos tratamientos antidepresivos adecuados de una duración de al menos 6 semanas.
4. El paciente ha utilizado o utiliza medicación reciente o concomitante no permitida (especificada en el Apéndice II, Medicación Reciente o Concomitante), o se prevé que requerirá tratamiento con al menos uno de los medicamentos concomitantes no permitidos durante el estudio.
5. El paciente ha recibido tratamiento electroconvulsivo en los 6 meses previos a la selección.
6. El paciente está recibiendo actualmente terapia cognitiva o conductual formal, psicoterapia sistemática, o prevé iniciar dichos tratamientos durante el estudio.
7. El paciente presenta una presión intraocular aumentada o tiene riesgo de glaucoma agudo de ángulo estrecho.
8. El paciente sufre una enfermedad inestable clínicamente significativa, por ejemplo, problemas hepáticos, insuficiencia renal; trastornos cardiovasculares, pulmonares, digestivos, endocrinos, neurológicos, infecciosos, neoplásicos, cutáneos o en el tejido subcutáneo; o trastornos metabólicos.
9. El paciente tiene una enfermedad hepática crónica.
10. El paciente tiene anomalías clínicamente significativas en las constantes vitales.
11. El paciente tiene una historia previa de falta de respuesta a un tratamiento adecuado con duloxetina (incluyendo el episodio en curso)
12. El paciente tiene una historia de alergia o hipersensibilidad grave a fármacos, o una hipersensibilidad conocida a duloxetina.
13. El paciente tiene uno o más valores de laboratorio fuera del intervalo normal, basándose en las muestras de sangre u orina obtenidas en la visita de Selección, y el investigador lo considera de importancia clínica.
14. El paciente tiene un valor de la TSH fuera del rango normal en la visita de Selección.
15. El paciente tiene anomalías clínicamente significativas en el ECG
16. El paciente tiene una enfermedad o toma una medicación que, de acuerdo con el criterio del investigador, puede interferir con la valoración de la seguridad, tolerabilidad o eficacia.
17. Se ha tratado al paciente con un medicamento en investigación en los 30 días ó 5 vidas medias (lo que sea más prolongado) previos a la selección.
18. La paciente está embarazada o en periodo de lactancia.
19. De acuerdo con el criterio del investigador es improbable que el paciente cumpla los procedimientos establecidos en el protocolo del estudio o es inadecuado por cualquier motivo.
20. El paciente es miembro del personal del centro o de sus familiares inmediatos.
21. El paciente ha participado previamente en este estudio.
22. Se ha expuesto previamente al paciente a Lu AA21004.

E.5 End points

E.5.1

Primary end point(s)

Evaluar la eficacia de tres dosis de Lu AA21004 (2,5mg, 5 mg, o 10 mg día) versus placebo a las ocho semanas de tratamiento.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

Yes

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.8.5

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

The end of the study for an individual patient is defined as the last protocol-specified contact with a patient. For patients entering into the extension study (11984B) the end of study is defined as the performance of the Completion Visit. The overall end of the study is defined as the last protocol-specific contact with the last patient ongoing in the study.

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-14.	Yes
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	40
F.4.2	For a multinational trial
F.4.2.1	In the EEA	324
F.4.2.2	In the whole clinical trial	660

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

2008-02-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-02-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-06-17

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