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    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-023900-29
    A.3Full 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.3.1Title 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.4.1Sponsor's protocol code numberMAF-AGN-OPH-RET-004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergan Pharmaceuticals Ireland
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAllergan Pharmaceuticals Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointAllergan Limited EU Regulatory Dept
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Bucks
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 494444
    B.5.5Fax number+44 1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OZURDEX 700 microgramos implante intravítreo en aplicador
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN PHARMACEUTICALS IRELAND
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETASONA
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name LUCENTIS 10 mg/ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANIBIZUMAB
    D.3.9.3Other descriptive nameRANIBIZUMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Macula oedema secondary to branch retinal vein occlusion.
    Edema macular secundario a oclusión de rama venosa retiniana.
    E.1.1.1Medical 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.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10025415
    E.1.2Term Macular oedema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10038907
    E.1.2Term Retinal vein occlusion
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary objectives of the trial
    Not applicable.
    No aplicable.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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.5.1Primary 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.5.1.1Timepoint(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.5.2Secondary 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.5.2.1Timepoint(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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If 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.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In 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.4.1Name of Organisation National Institute for Health Research
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-04
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