Clinical Trials Register

Summary
EudraCT Number:	2010-023900-29
Sponsor's Protocol Code Number:	MAF-AGN-OPH-RET-004
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:	2011-07-01
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

2010-023900-29

A.3

Full title of the trial

A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare the Efficacy and Safety of Ozurdex® Versus Lucentis® in Patients with Branch Retinal Vein Occlusion.

Estudio de 12 meses de duración, multicéntrico, aleatorizado y de grupos paralelos para comparar la eficacia y seguridad de Ozurdex® frente a Lucentis® en pacientes con oclusión de rama venosa retiniana.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparison of Ozurdex versus Lucentis in the treatment of Branch
Retinal Vein Occlusion.

Comparación de Ozurdexfrente a Lucentis en el tratamiento de oclusión de rama venosa retiniana.

A.4.1

Sponsor's protocol code number

MAF-AGN-OPH-RET-004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Allergan Pharmaceuticals Ireland
B.1.3.4	Country	Ireland
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	Allergan Pharmaceuticals Ireland
B.4.2	Country	Ireland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Allergan Limited
B.5.2	Functional name of contact point	Allergan Limited EU Regulatory Dept
B.5.3	Address:
B.5.3.1	Street Address	1st Floor, Marlow International, The Parkway
B.5.3.2	Town/ city	Marlow, Bucks
B.5.3.3	Post code	SL7 1YL
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 1628 494444
B.5.5	Fax number	+44 1628 494449
B.5.6	E-mail	ml-eu_reg_affairs@allergan.com

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	OZURDEX 700 microgramos implante intravítreo en aplicador
D.2.1.1.2	Name of the Marketing Authorisation holder	ALLERGAN PHARMACEUTICALS IRELAND
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.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXAMETASONA
D.3.9.1	CAS number	50-02-2
D.3.9.3	Other descriptive name	DEXAMETHASONE
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	700
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	LUCENTIS 10 mg/ml solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD.
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravitreal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RANIBIZUMAB
D.3.9.3	Other descriptive name	RANIBIZUMAB
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Macula oedema secondary to branch retinal vein occlusion.

Edema macular secundario a oclusión de rama venosa retiniana.

E.1.1.1

Medical condition in easily understood language

Blockage of veins in the eye that leads to build up of fluid causing
swelling in the area of the retina called the macula. This may lead to
damage to the macula which affects your central vision.

Obstrucción de las venas del ojo que conduce a la acumulación de líquido que causa hinchazón en el área de la retina llamada mácula. Esto puede llevar a daño a la mácula, que afecta la visión central.

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10025415
E.1.2	Term	Macular oedema
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10038907
E.1.2	Term	Retinal vein occlusion
E.1.2	System Organ Class	10015919 - Eye disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy and safety of Ozurdex vs. Lucentis in subjects with BRVO.

Comparar la eficacia y la seguridad de Ozurdex vs. Lucentis en sujetos con ORVR.

E.2.2

Secondary objectives of the trial

Not applicable.

No aplicable.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, ? 18 years of age
2. Written informed consent has been obtained
3. Written Data Protection Consent (European sites only) has been
obtained
4. Study eye must have clear ocular media and adequate pupil dilation to
permit good quality photographic imaging
5. ME secondary to BRVO in the study eye with all of the following
characteristics:
a) involving the centre of the macula (fovea)
b) central retina subfield thickness more or equal 320 ?m as assessed with Spectralis
optical coherence tomography (OCT) or more or equal 300 ?m as assessed with Cirrus OCT
c) less than 90 days from onset of BRVO symptoms to screening visit
d) visual acuity (VA) decrease attributable to retinal oedema
Note: Characteristics a and b will be confirmed by a CRC
6. Absence of severe macular ischemia (defined as an area of
nonperfusion > 4 disc areas [DA] which involve the foveal avascular
zone), as confirmed by a CRC
7. BCVA score of ? 20 to ? 70 letters (20/40 to 20/400 Snellen equivalent) using the Early Treatment Diabetic Retinopathy Study
(ETDRS) visual acuity protocol at both the screening visit and day 1 visit.
8. Female subjects of childbearing potential must have a negative urine
pregnancy test at the screening (day -14) visit.

1.Hombre o mujer, mayor o igual a 18 años de edad
2.Obtención del consentimiento informado por escrito
3.Obtención del consentimiento de protección de datos por escrito (sólo en centros europeos)
4.El ojo de estudio debe tener los medios oculares transparentes y una dilatación pupilar adecuada para permitir la toma de imágenes fotográficas de buena calidad.
5.EM secundario a ORVR en el ojo de estudio con todas las características siguientes:
a)afectación del centro de la mácula (fóvea)
b)Espesor del subcampo central de la retina mayor o igual a 320 micrometros, según una evaluación realizada mediante tomografía de coherencia óptica (TCO) Spectralis, o mayor o igual a 300 micrometros, según una evaluación realizada mediante TCO Cirrus
c)inicio de los síntomas de ORVR a menos de 90 días de la visita de selección
d)disminución de la agudeza visual (AV) atribuible al edema retiniano
Nota: Las características a y b serán confirmadas por el CLC
6.Ausencia de isquemia macular severa (definida como la existencia de un área no perfundida > 4 áreas de disco [AD] que afectan a la zona avascular de la fóvea), confirmado por el CLC
7.Puntuación MAVC mayor o igual 20 y menor o igual 70 letras (de 20/40 a 20/400 en su equivalente de Snellen) evaluada mediante el protocolo de agudeza visual del estudio de tratamiento precoz de la retinopatía diabética (ETDRS), tanto en la visita de selección como en la visita del día 1.
8.Los sujetos femeninos en edad fértil deberán tener una prueba de embarazo en orina negativa en la visita de selección (día -14).

E.4

Principal exclusion criteria

1. History of a medical condition (disease, metabolic dysfunction,
physical examination finding or clinical laboratory finding) that, in the
opinion of the investigator, would preclude scheduled study visits,
completion of the study, or a safe administration of study medication.
2. Ocular hypertension unless controlled with monotherapy.
3. Pregnant or nursing (lactating) women, where pregnancy is defined
as the state of a female after conception and until the termination of
gestation, confirmed by a positive urine (human chorionic gonadotropin
[hCG] > 20 mIU/ml) or serum pregnancy test (hCG ? 5 mIU/ml).
4. Pre-menopausal women of child-bearing potential not using adequate
contraception. Women of child-bearing potential are defined as all
women physiologically capable of becoming pregnant. This includes
women whose career, lifestyle, or sexual orientation precludes
intercourse with a male partner and women whose partners have been
sterilized by vasectomy or other means unless they meet the following
definition of postmenopausal:12 months of natural (spontaneous)
amenorrhea or 6 months of spontaneous amenorrhea with serum
follicle-stimulating hormone levels of > 40 mIU/m or 6 weeks post
surgical bilateral oophorectomy with or without hysterectomy. Adequate
contraception is defined as one or more of the following methods:
surgical sterilization (eg, bilateral tubal ligation), hormonal
contraception (implantable, patch, oral), and double-barrier methods
(any double combination of intrauterine device, male or female condom
with spermicidal gel, diaphragm, sponge, or cervical cap). Acceptable
methods of contraception may include total abstinence at the discretion
of the investigator in cases where the age, career, lifestyle, or sexual
orientation of the subject ensures compliance. Periodic abstinence (eg,
calendar, ovulation, symptothermal, postovulation methods) and
withdrawal are not acceptable methods of contraception. Reliable
contraception should be maintained throughout the study and for 30
days after the administration of the last study drug injection.
Note: Instruct females of childbearing potential to immediately inform
the investigator if they become pregnant during the study. Should this
occur, the investigator shall immediately contact the Sponsor as detailed
in Sections 9.2 and 9.3 of the protocol.
5. Participation in an investigational drug or device study within 30 days
of the screening visit
6. Any current or history of ocular disease in the study eye other than
RVO that, in the opinion the investigator, may confound assessment of
the macula or affect central vision, such as exudative age-related
macular degeneration, geographic atrophy, diabetic retinopathy, uveitis,
angioid streaks, histoplasmosis, pathological myopia, retinal
detachment, epiretinal membrane, macular hole, or significant cataract
7. History of cataract surgery in either eye within the past 3 months
prior to the screening visit
8. History or evidence of serious ocular trauma or intraocular surgery
(such as laser-assisted in situ keratomileusis, keratoplasty, vitrectomy)
in the study eye within the past 6 months prior to the screening visit
9. History of severe or serious hypersensitivity to any components of the
test article or fluorescein dye.
10. > 10-Letter improvement in BCVA between the screening visit and
day 1
11. Brisk afferent pupillary defect (ie, obvious and unequivocal)
12. Aphakia in the study eye or violation of the posterior capsule in the
study eye, unless it occurred as a result of a yttrium-aluminum-garnet
laser posterior capsulotomy in association with prior, posterior
intraocular lens implantation
13. Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in
adnexa of either eye
14. History of radial optic neurotomy or sheathotomy
15. Laser photocoagulation for ME in the study eye within 3 months prior
to the screening visit
16. Anticipated need for ocular surgery or ophthalmic laser treatment in
the study eye during the 12-month study period
17. Prior anti-VEGF treatment in study or fellow eye within 3 months of
screening or systemic anti-VEGF treatment within 6 months of the
screening visit
18. Use of intraocular, intravitreal, or peri-ocular steroids in the study
eye within 3 months of the screening visit
19. Use of systemic steroids (eg, oral, intravenous, intra-articular,
epidural, intrabursal) within 1 month of screening or anticipated use at
any time during the study. Inhaled and intranasal steroids are allowed.
20. IOP > 22 mm Hg at screening or day 1 visit in either eye.

1.Antecedentes de afecciones médicas (enfermedades, disfunciones metabólicas, hallazgos de exploraciones físicas o hallazgos de análisis clínicos) que impedirían el cumplimiento de las visitas de estudio programadas, la finalización del estudio o la administración segura del medicamento de estudio.
2.Hipertensión ocular, salvo que esté controlada con monoterapia
3.Mujeres embarazadas o en periodo de lactancia,
4.Mujeres premenopáusicas en edad fértil que no utilicen métodos anticonceptivos adecuados.
5. Participación en un estudio sobre un fármaco o dispositivo en investigación a menos de 30 días de la visita de selección
6.Cualquier antecedente de enfermedad ocular o enfermedad ocular actual del ojo de estudio, aparte de OVR, que en opinión del investigador pueda confundir la evaluación de la mácula o afectar a la visión central, como sucede en los siguientes casos: degeneración macular exudativa relacionada con la edad, atrofia geográfica, retinopatía diabética, uveítis, estrías angioides, histoplasmosis, miopía patológica, desprendimiento de retina, membrana epirretiniana, agujero macular o catarata significativa
7.Antecedentes de cirugía de catarata en cualquiera de los ojos en los últimos 3 meses anteriores a la visita de selección
8.Antecedentes o evidencia de traumatismo ocular importante o cirugía intraocular (como queratomileusis in situ asistida por láser, queratoplastia o vitrectomía) en el ojo de estudio en los últimos 6 meses antes de la visita de selección
9.Antecedentes de hipersensibilidad grave o severa en cualquiera de los componentes del artículo de prueba o tinte de fluoresceína.
10.Mejora de 10 letras en la MAVC entre la visita de selección y el día 1
11.Defecto pupilar aferente rápido (es decir, obvio e inequívoco)
12.Afaquia en el ojo de estudio o compromiso de la cápsula posterior del ojo de estudio, salvo que sea el resultado de una capsulotomía posterior mediante láser de itrio-aluminio-granate asociada a la implantación previa de una lente intraocular posterior
13.Cualquier infección ocular activa (es decir, bacteriana, vírica o fúngica) en los anexos de cualquier ojo
14.Antecedentes de neurotomía óptica radial o descompresión de la vaina del nervio óptico
15.Fotocoagulación con láser para tratar un EM en el ojo de estudio en los 3 meses anteriores a la visita de selección
16.Necesidad anticipada de cirugía ocular o tratamiento oftalmológico con láser en el ojo de estudio durante el periodo de 12 meses del estudio
17.Tratamiento previo anti-FCEV en el ojo de estudio o el ojo contralateral a menos de 3 meses de la selección o tratamiento sistémico anti-FCEV a menos de 6 meses de la visita de selección
18.Uso intraocular, intravítreo o periocular de esteroides en el ojo de estudio a menos de 3 meses de la visita de selección
19.Uso de esteroides sistémicos (por ejemplo, orales, intravenosos, intraarticulares, epidurales o intrabursales) a menos de 1 mes de la selección o uso anticipado de los mismos en cualquier momento del estudio. Se permite el uso de esteroides inhalados e intranasales.
20.PIO > 22 mm de Hg en la visita de selección o del día 1 en cualquier de los ojos.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable is mean change in BCVA at month 12.

La variable principal de eficacia es la variación media de la MAVC (mejor agudeza visual corregida) en el mes 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

BCVA assessment at screening, baseline, day 7 and at each monthly visit.

Evaluación BCVA en la visita de selección, de referencia, dia 7 y en cada visita mensual.

E.5.2

Secondary end point(s)

1. Mean change in the central retina subfield thickness between baseline
and month 6, and between baseline and month 12
2. Proportion of subjects with ? 15-letter improvement in BCVA between
baseline and month 12
3. Proportion of subjects with ? 15-letter decrease in BCVA between
baseline and month 12
4. Change from baseline in vision-dependent subfields of the VFQ-25
questionnaire including near vision, far vision, and vision-dependent
activity at month 3, month 6, and month 12.

1.Variación media del espesor del subcampo central de la retina entre el inicio y el mes 6, y entre el inicio y el mes 12.
2.Proporción de sujetos con mejoras ? 15 letras en la MAVC entre el inicio y el mes 12.
3.Proporción de sujetos con disminuciones ? 15 letras en la MAVC entre el inicio y el mes 12.
4.Variación de las mediciones en los subcampos dependientes de la visión en el cuestionario VFQ-25, incluidas la visión de cerca, la visión de lejos y la actividad desde la visita basal a los 3, 6 y 12 meses.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. OCT assessments that will be used in evaluation of timepoint will be
done at baseline, month 6 and month 12.
2. and 3. BCVA assessments that will be used in evaluation of timepoints
will be done at baseline and month 12.
4. VFQ-25 questionnaire completed at baseline, month 3, month 6, and
month 12.

1. Evaluaciones de OTC que serán usadas en la evaluación de la variable principal serán hechas en la visita de referencia, mes 3, mes 6 y mes 12.
2. y 3. Evaluaciones de BCVA que seránm usadas en la evaluación de los tiempos de evaluación serán hechas en la visita de referencia y mes 12.
4. Cuestionario VFQ-25 se completará en visita de referencia, mes 3, mes 6 y mes 12.

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

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

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

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

France

Germany

Israel

Italy

Spain

United Kingdom

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

Last visit last subject

Última visita del último sujeto

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

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

360

F.4.2.2

In the whole clinical trial

400

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)

Subjects will return to their standard of care treatment as determined by their physician after completion of the trial.

Tras completar el ensayo, los sujetos volverán a su tratamiento habitual según lo determinado por su médico.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	National Institute for Health Research
G.4.3.4	Network Country	United Kingdom

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-08-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-08-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-11-04

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IMP with orphan designation in the indication
Orphan Designation Number:
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