Clinical Trials Register

Summary
EudraCT Number:	2008-002158-40
Sponsor's Protocol Code Number:	A6181120
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2008-05-30
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

2008-002158-40

A.3

Full title of the trial

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN

ESTUDIO EN FASE 3, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO DE SUNITINIB MÁS PREDNISONA EN COMPARACIÓN CON PREDNISONA EN PACIENTES CON CÁNCER DE PRÓSTATA METASTÁTICO, PROGRESIVO Y RESISTENTE A LAS HORMONAS TRAS EL FRACASO DE UNA PAUTA DE QUIMIOTERAPIA BASADA EN EL DOCETAXEL

A.4.1

Sponsor's protocol code number

A6181120

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	Pfizer S.A.
B.1.3.4	Country	Spain
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	Yes
D.2.1.1.1	Trade name	Sutent
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
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	Sunitinib Malate
D.3.2	Product code	SU-011248 -Malate Salt
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	Sunitinib Malate
D.3.9.1	CAS number	341031-54-7
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	12.5
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	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	Yes
D.2.1.1.1	Trade name	Sutent
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
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	Sunitinib Malate
D.3.2	Product code	SU-011248-Malate salt
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	Sunitinib Malate
D.3.9.1	CAS number	341031-54-7
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: 3
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	Yes
D.2.1.1.1	Trade name	Sutent
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
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	Sunitinib Malate
D.3.2	Product code	SU-011248 -Malate Salt
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	Sunitinib Malate
D.3.9.1	CAS number	341031-54-7
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	37.5
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: 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	Yes
D.2.1.1.1	Trade name	Sutent
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
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	Sunitinib Malate
D.3.2	Product code	SU-011248-Malate Salt
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	Sunitinib Malate
D.3.9.1	CAS number	341031-54-7
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.IMP: 5
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	Dacortin (Prednisone)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Farma y Química
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	DACORTIN
D.3.2	Product code	H02AB
D.3.4	Pharmaceutical form	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.3.8	INN - Proposed INN	PREDNISONA
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.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

(mHRPC) after failure of a docetaxel-based chemotherapy regimen
Cáncer de próstata resistente a las hormonas metastático (CPRHm) tras el fracaso de una pauta de quimioterapia basada en el docetaxel

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	10062904
E.1.2	Term	Hormone-refractory prostate cancer

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

•Demostrar la superioridad en la supervivencia global (SG) del tratamiento con sunitinib más prednisona (SP) en comparación con placebo más prednisona (PP) en pacientes con CPRHm progresivo tras el fracaso de una pauta de quimioterapia basada en el docetaxel.

E.2.2

Secondary objectives of the trial

• Demostrar la superioridad en la supervivencia sin progresión (SSP) del tratamiento con SP en comparación con PP en pacientes con CPRHm progresivo tras el fracaso de una pauta de quimioterapia basada en el docetaxel.
• Comparar la tasa de respuestas objetivas (TRO) y la duración de la respuesta (DR) entre SP y PP en pacientes con CPRHm progresivo tras el fracaso de una pauta de quimioterapia basada en el docetaxel.
• Comparar los resultados comunicados por los pacientes (RCP) de intensidad del dolor, calidad de vida relacionada con la salud, síntomas específicos del cáncer de próstata y salud general entre SP y PP en pacientes con CPRHm progresivo tras el fracaso de una pauta de quimioterapia basada en el docetaxel.
• Evaluar la seguridad y la tolerabilidad del sunitinib en combinación con prednisona.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adenocarcinoma de próstata, confirmado por histología o por citología.
2. Cáncer de próstata metastático resistente a las hormonas (resistente a la supresión de los andrógenos). Los pacientes deben encontrarse en estado de castración quirúrgica o química, con una concentración de testosterona basal <50 ng/dl.
3. Los pacientes deberán haber experimentado un fracaso de la pauta de quimioterapia a base de docetaxel previa para el tratamiento de la enfermedad metastática, definido por la PE durante el tratamiento con docetaxel (resistente al docetaxel) o por intolerancia del docetaxel (abandono del tratamiento por toxicidad inaceptable, en opinión del médico a cargo del tratamiento o del paciente). En el caso de que se hayan observado PE e intolerancia durante el tratamiento basado en el docetaxel, se considerará a la PE como criterio de entrada dominante.
4. Los pacientes deberán acreditar la EP, definida por:
• Progresión del PSA: mínimo de 2 elevaciones (3 mediciones) obtenidas con una semana de diferencia como mínimo, y con el último resultado de 2,0 ng/ml como mínimo,

• RECIST, o

Gammagrafía ósea positiva, con dos o más lesiones nuevas.
5. Estado funcional (ECOG) de 0 ó 1
6. Resolución de todos los efectos tóxicos agudos del tratamiento previo (excepto de la alopecia y la neuropatía) o del procedimiento quirúrgico previo a un grado ≤1 o al valor basal antes del tratamiento.
7. Función orgánica adecuada según lo definido por los criterios siguientes:
Aspartato aminotransferasa sérica (AST; transaminasa glutámico oxaloacética sérica [SGOT]) y alanina aminotransferasa sérica (ALT; transaminasa glutámico pirúvica sérica [SGPT]) ≤2,5 x límite superior de la normalidad (LSN) o ≤5 x LSN en los pacientes con metástasis óseas
Bilirrubina total sérica ≤1,5 x LSN.
Recuento absoluto de neutrófilos (RAN) ≥ 1500/µl
Plaquetas ≥ 100.000/ µl
Hemoglobina ≥ 9,0 g/dl
Creatinina sérica ≤2 x LSN
Intervalo QTc ≤470 ms
Fracción de eyección del ventrículo izquierdo (FEVI) ≥ límite inferior de normalidad (LIN) del centro, evaluada mediante ventriculografía isotópica en equilibrio (MUGA) o ecocardiograma (ECHO).
8. Documento de consentimiento informado firmado y fechado en el que se indica que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del estudio antes de su inclusión.
9. Disposición y capacidad de cumplir las visitas programadas, los planes de tratamiento, las pruebas analíticas y otros procedimientos del estudio, entre ellos, la cumplimentación de los cuestionarios de resultados comunicados por los pacientes (RCP) y del diario sobre el uso de analgésicos.

E.4

Principal exclusion criteria

1. Tratamiento previo con sunitinib (en cualquier circunstancia clínica) y/o más de una pauta de quimioterapia previa en el contexto del tratamiento de la enfermedad metastática.
2. Quimioterapia en las 3 semanas previas a la entrada en el estudio.
3. Radioterapia con estroncio 89 o con samario en las 12 semanas previas a la entrada en el estudio.
4. Radioterapia (incluida la de tipo paliativo de las lesiones metastáticas) en las 2 semanas previas, o intervención quirúrgica importante (p. ej., abdominal abierta, pélvica, torácica, ortopédica o de neurocirugía).
5. Tratamiento actual en otro ensayo clínico terapéutico.
6. Complicaciones inminentes de las metástasis óseas (fractura y/o compresión medular).
7. Presencia de obstrucción urinaria (p. ej., retención urinaria, hidronefrosis) que requiera intervención médica. Se permiten las obstrucciones urinarias correctamente tratadas.
8. Hemorragia de grado ≥3 en las 4 semanas previas a la entrada en el estudio.
9. Arritmias cardíacas de grado ≥2 en la actualidad.
10. Hipertensión que no se puede controlar con fármacos (>150/100 mm Hg a pesar del tratamiento médico óptimo).
11. Tratamiento activo con dosis terapéuticas (niveles terapeúticos de INR) de derivados cumarínicos o antagonistas de la vitamina K orales.
12. Diagnóstico de una segunda neoplasia maligna en los últimos 3 años, salvo carcinoma basocelular, cáncer de piel espinocelular, carcinoma en estadio I totalmente tratado o carcinoma in situ que ha sido tratado correctamente sin signos de recidiva durante 12 meses.
13. Cualquiera de los trastornos siguientes en los 6 meses previos a la administración del fármaco del estudio: angina grave/inestable, infarto de miocardio, insuficiencia cardíaca congestiva sintomática, embolia pulmonar, accidente cerebrovascular o accidente isquémico transitorio.
14. Presencia o sospecha de metástasis cerebrales (se permiten las metástasis del cráneo), compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea.
15. Infección conocida por el virus de la inmunodeficiencia humana (VIH).
Otras enfermedades médicas o psiquiátricas graves agudas o crónicas o anomalías analíticas que puedan implicar, en opinión del investigador, un riesgo excesivo asociado a la participación en el estudio o a la administración del fármaco del estudio, o que, a criterio del investigador, hagan que el paciente no sea candidato a participar en este
16. Otras enfermedades médicas o psiquiátricas graves agudas o crónicas o anomalías analíticas que puedan implicar, en opinión del investigador, un riesgo excesivo asociado a la participación en el estudio o a la administración del fármaco del estudio, o que, a criterio del investigador, hagan que el paciente no sea candidato a participar en este estudio.

E.5 End points

E.5.1

Primary end point(s)

Supervivencia global (SG)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Information not present in EudraCT

E.6.2

Prophylaxis

Information not present in EudraCT

E.6.3

Therapy

Information not present in EudraCT

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Information not present in EudraCT

E.6.7

Pharmacodynamic

Information not present in EudraCT

E.6.8

Bioequivalence

Information not present in EudraCT

E.6.9

Dose response

Information not present in EudraCT

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

Information not present in EudraCT

E.6.12

Pharmacoeconomic

Information not present in EudraCT

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Superiority

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

Information not present in EudraCT

E.8.4

The trial involves multiple sites in the Member State concerned

Information not present in EudraCT

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

108

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

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.8.9.1

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	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	No
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	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
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	370
F.4.2.2	In the whole clinical trial	819

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

2008-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-07-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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