Clinical Trials Register

Summary
EudraCT Number:	2006-006015-72
Sponsor's Protocol Code Number:	CR9108963
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:	2007-04-02
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

2006-006015-72

A.3

Full title of the trial

Estudio CR9108963: Estudio de búsqueda de dosis optima de SB-751689 en mujeres posmenopáusicas con osteoporosis

A.4.1

Sponsor's protocol code number

CR9108963

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	GlaxoSmithkline 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	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.3.2	Product code	SB-751689-A
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.3.9.2	Current sponsor code	SB-751689-A
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	100
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	Information not present in EudraCT
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.3.2	Product code	SB-751689-A
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.3.9.2	Current sponsor code	SB-751689-A
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	200
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	Information not present in EudraCT
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	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.3.2	Product code	SB-751689-A
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.3.9.2	Current sponsor code	SB-751689-A
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	300
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	Information not present in EudraCT
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.3.2	Product code	SB-751689-A
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.3.9.2	Current sponsor code	SB-751689-A
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	400
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	Information not present in EudraCT
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	Fosamax 70 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp and Dohme Espana
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	Fosamax 70 mg
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	Alendronate sodium trihydrate
D.3.9.3	Other descriptive name	Fosamax 70 mg
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	70
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	Information not present in EudraCT

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	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	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

Osteoporosis en mujeres posmenopáusicas

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	10031285
E.1.2	Term	Osteoporosis postmenopausal

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Caracterizar la dosis-respuesta de SB-751689 respecto a la seguridad y eficacia de acuerdo con la DMO y los biomarcadores de remodelado óseo para permitir la selección de dosis para estudios ulteriores.

E.2.2

Secondary objectives of the trial

Evaluar seguridad y tolerabilidad de SB-751689 administrado 12 meses en mujeres posmenopáusicas en comparación con placebo, alendronato y teriparatida. Demostrar un aumento estadísticamente significativo de la DMO determinada por DXA en columna vertebral lumbar y de la DMO determinada por DXA en cadera total, cuello femoral y trocanter después de 6 y 12 meses con SB-751689 en comparación con placebo. Investigar el efecto de SB-751689 sobre los biomarcadores de remodelado óseo, sobre densidad volumétrica integral, cortical y trabecular, anchura cortical y otros parámetros en columna lumbar y cadera, determinados por QCT en una subpoblación de pacientes del estudio, los efectos de SB-751689 sobre los parámetros de resistencia vertebral y de la cadera, determinados por análisis de elementos finitos derivados de QCT, los efectos de SB-751689 sobre los parámetros del análisis estructural de la cadera, determinados por DXA y relación FC/FD de SB-751689 en esta población.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Para ser incluidas, las participantes deberán cumplir :
1.Consentimiento informado: La participante acepta y está capacitada para otorgar su consentimiento informado.
2.Estado menopáusico: Mujeres en régimen ambulatorio menores de 80 años en la selección, con posmenopausia > 5 años, que puede consistir en > 5 años de amenorrea espontánea o > 5 años de ooforectomía bilateral. Si el antecedente de ooforectomía bilateral es incierto, se emplearán concentraciones de hormona foliculoestimulante [FSH] > 40 mUI/mL para confirmar el estado de posmenopausia quirúrgica.
3. Puntuación T: Las pacientes sin fractura o con una única fractura vertebral prevalente serán elegibles para el estudio si cumplen alguno de los siguientes valores de puntuación T.
- sin fractura vertebral prevalente y una puntuación T de la DMO menor o igual que -2.5 y mayor que 4,0 en cuello del fémur, trocánter, cadera total o columna lumbar
o
- en caso de una fractura vertebral prevalente las pacientes tendrán una puntuación T de la DMO menor o igual a -2.0 y mayor a -4.0 en cuello del fémur, trocánter, cadera total o columna lumbar (Se define como fractura la reducción del 20 % de la altura vertebral anterior, media o posterior determinada en el centro por DXA semicuantitativa).
4. Vértebra idónea: Hay dos o más vértebras de L1 a L4 adecuadas para la determinación de la DMO por DXA.
5. Cumplimiento del protocolo: La participante, en opinión del investigador, está de acuerdo y capacitada para cumplir los requisitos del protocolo.

E.4

Principal exclusion criteria

No podrán ser incluidas en el estudio las participantes que cumplan cualquiera de los criterios siguientes:
1.Puntuación T: Paciente que presente una puntuación T de la DMO inferior o igual a -4,0 en el cuello femoral, la cadera total o la columna lumbar.
2.Fracturas vertebrales: Presenta > 1 fractura vertebral prevalente en la visita de selección (definiéndose como fractura la reducción del 20 % de la altura vertebral anterior, media o posterior determinada por DXA semicuantitativa en el centro).
3.Fracturas no vertebrales: Cualquier fractura previa no vertebral osteoporótica por fragilidad a partir de los 40 años.
4.Anomalías clínico-biológicas: Cualquier anomalía biológica clínicamente relevante observada y/o manifestada durante la selección (diferente de las relacionadas con la enfermedad en investigación) que, sea clínicamente significativa e impida la participación con seguridad en este estudio [p. ej., infección por el virus de la inmunodeficiencia humana (VIH), hepatitis crónicas B y C (demostradas por positividad del antígeno de superficie de la hepatitis B (AgsHB) o de anticuerpos frente a la hepatitis C), enfermedad mental significativa].
5.Enfermedades orgánicas y quirúrgicas: Presencia de las siguientes enfermedades durante los 6 meses anteriores a la selección: infarto de miocardio, cirugía de bypass coronario, angioplastia coronaria, angina inestable, arritmias, insuficiencia cardíaca congestiva clínicamente evidente o accidente vascular cerebral.
6.Aclaramiento de creatinina: Aclaramiento de creatinina (ClCr) < 35 ml/min calculada por la ecuación de la Modificación de la Dieta en la Insuficiencia Renal (MDIR), como sigue: ClCr (mL/min/1,73 m2) = 186 x (Creatinina sérica mg/dl)-1,154 x (Edad)-0,203 x (0,742 en mujeres) x (1,210 en afroamericanos) (unidades convencionales).
7.Prolongación QT/QTc: Destacada prolongación basal del intervalo QT/QTc (p. ej., demostración repetida de un intervalo QTc > 450 ms en el ECG de selección).
8.Torsades de Pointes: Antecedentes de factores de riesgo de torsades de pointes (p. ej., insuficiencia cardíaca, hipocaliemia, antecedentes familiares de síndrome del QT largo).
9.Bioquímica hepática: Bioquímica hepática [aspartato aminotransferasa (AST), alanina aminotransferasa (ALT), fosfatasa alcalina o bilirrubina total] superior a 2 veces el LSN del intervalo de referencia del laboratorio, en la selección.
10.Alteraciones del calcio sérico: Calcio sérico (total o ajustado por albúmina) fuera del intervalo de referencia del laboratorio central en la visita de selección.
11.Alteraciones de la PTH: PTH (“whole” e “intact”) fuera del intervalo normal.
12.Bisfosfonatos orales: Cualquier tratamiento previo con un bisfosfonato oral, en los términos siguientes:
•cualquier tratamiento durante los últimos 6 meses
•≥ 1 mes de tratamiento acumulado durante los últimos 12 meses
•≥ 3 meses de tratamiento acumulado durante los últimos 2 años
•≥ 2 años de tratamiento acumulado durante los últimos 5 años
13.Fármacos que afectan al metabolismo óseo: Tratamiento con otros fármacos que influyen sobre el metabolismo óseo durante los 6 meses anteriores a la selección:
•Corticoterapia sistémica crónica [p. ej., glucocorticoides, mineralocorticoides] con no más de 2 inyecciones intraarticulares durante el último año o utilización de corticoides orales, parenterales, intraarticulares o inhalados a dosis elevadas y a largo plazo. El tratamiento con cualquier corticosteroide tópico no será motivo de exclusión.
•Tratamiento con hormonas [p. ej., estrógenos/"preparados de estrógenos naturales"(excepto el tratamiento vaginal no sistémico), 19-norprogestágenos, SERMs como raloxifeno, esteroides anabolizantes/andrógenos como la deshidroepiandrosterona (DHEA) o su forma en sulfato (DHEAS), nandrolona, tibolona, análogos de la vitamina D activa/metabolitos como la 1,25 dihidroxivitamina D (calcitriol) o 1 alfa-hidroxivitamina D3 (1-alfa hidroxicolecalciferol), calcitonina].
•Tratamiento con inhibidores de la calcineurina [p. ej., ciclosporina, tacrólimus] o metotrexato.
14.Anabolizantes previos: Tratamiento con PTH, análogos de la PTH o anabolizantes similares para la osteoporosis en los últimos 2 años.
15.Contraindicaciones: Contraindicaciones al tratamiento con calcio, vitamina D o alendronato.

E.5 End points

E.5.1

Primary end point(s)

La variable principal es la variación porcentual media de la DMO de la columna lumbar determinada por DXA a los 12 meses respecto al valor basal.

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

Information not present in EudraCT

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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

Investigation of toleribility of SB-751689

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Information not present in EudraCT

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Information not present in EudraCT

E.7.4

Therapeutic use (Phase IV)

Information not present in EudraCT

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

Information not present in EudraCT

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

Information not present in EudraCT

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

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

El final del estudio es la última visita del último paciente

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

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

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

208

F.4.2.2

In the whole clinical trial

520

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No se facilitará ningún tratamiento despues de finalizado el estudio.

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

2007-07-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-05-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-12-26

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