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    Summary
    EudraCT Number:2014-005556-25
    Sponsor's Protocol Code Number:OFT-ETAMSILATO-4.2.2
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-02-17
    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 number2014-005556-25
    A.3Full title of the trial
    Open extension study for patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulatedcontrolled treatment to evaluate safety and efficacy of intravitreal etamsilato code OFT-ETAMSILATO -4.2.1
    Estudio abierto de extensión para los pacientes con degeneración macular asociada a la edad que han participado en el ensayo clínico aleatorizado de fase IV-II controlado con tratamiento fingido sobre la eficacia y seguridad de etamsilato intravítreo código OFTETAMSILATO-4.2.1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open extension study for patients with age related macula degeneration who participated in the Fase IV-II clinical trial randomized, simulated and blinded controlled treatment to evaluate safety and efficacy of a drug administered (etamsilato) via a needle in the eye. Clinical trial code OFT-ETAMSILATO -4.2.1
    Estudio abierto de extensión para los pacientes con degeneración macular asociada a la edad que han participado en el ensayo clínico de fase IV-II distribuido al azar, enmascarado con tratamiento fingido sobre la eficacia y seguridad al administrar un medicamento (etamsilato) mediante un pinchazo en el ojo. Código del ensayo clínico OFTETAMSILATO-4.2.1.
    A.4.1Sponsor's protocol code numberOFT-ETAMSILATO-4.2.2
    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 SponsorInvestigacion Independiente
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDR. PEDRO CUEVAS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeon Research S.L.
    B.5.2Functional name of contact pointRocio Garcia Cañamaque
    B.5.3 Address:
    B.5.3.1Street AddressBurgo Nuevo 16, 1-G
    B.5.3.2Town/ cityLeon
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034987261 064
    B.5.5Fax number0034987216 243
    B.5.6E-mailrgcanamaque@leonresearch.es
    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 DICYNONE 250 mg/2 ml, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 INNEtamsylate
    D.3.9.1CAS number 2624-44-4
    D.3.9.3Other descriptive nameETAMSYLATE
    D.3.9.4EV Substance CodeSUB11943MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.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
    Aged related macula degeneration (ARMD)
    Degeneración macular asociada a la edad (DMAE)
    E.1.1.1Medical condition in easily understood language
    Aged related macula degeneration
    Degeneración macular asociada a la edad
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of treatment received in the previous clinical trial (intravitreal ethamsylate or simulated treatment) in improvement of the visual acuity in patients diagnosed with dry or wet aged related macular degeneration disease after a non-interventionist tracking "treated eye" in the clinical trial until the week 48 of the double blinded treatment administration. This objective will be valued only in patients not receiving intravitreal ethamsylate in the extension study.
    Evaluar el efecto del tratamiento recibido en el ensayo clínico precedente (etamsilato intravítreo o tratamiento fingido) en la mejora de la agudeza visual en pacientes diagnosticados de DMAE seca o exudativa tras un seguimiento no intervencionista del "ojo tratado" en el ensayo clínico hasta la semana 48 de la administración del tratamiento doble enmascarado. Este objetivo se valorará solo en pacientes que no reciban etamsilato intravítreo en el estudio de extensión.
    E.2.2Secondary objectives of the trial
    -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 regarding efficacy in improvement visual acuity in patients diagnosed of dry or wet ARMD
    -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 to revert the structural changes in the retina associated to ARMD
    -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 in the contrast sensibility
    -Evaluate the effect of intravitreal ethamsylate (1 or 2 doses) or simuled treatment until the week 48 on the quality of life of patients.
    Safety:
    -Incidence of serious and severe adverse events related with the intravitreal ethamsylate (1 or 2 doses) or simuled treatment during the participation in the study.
    -Evaluate the changes in the intraocular pressure after the intravitreal ethamsylate injections(1 or 2 doses) or simuled treatment and its evolution during the participation in the study.
    -Evaluar el efecto de etamsilato intravítreo (1 o 2 dosis) o del tratamiento fingido hasta la semana 48 respecto a la eficacia en la mejora de la agudeza visual en pacientes diagnosticados de DMAE seca o exudativa.
    -Evaluar el efecto de etamsilato intravítreo (1 o 2 dosis) o del tratamiento fingido hasta la semana 48 para revertir los cambios estructurales de la retina asociados a la DMAE
    -Evaluar el efecto del etamsilato intravítreo (1 o 2 dosis) o tratamiento fingido hasta la semana 48 en la sensibilidad al contraste.
    -Evaluar el efecto del etamsilato intravítreo (1 o 2 dosis) o tratamiento fingido hasta la semana 48 sobre la calidad de vida de los pacientes.
    Seguridad:
    -Evaluar la incidencia de acontecimientos adversos con etamsilato intravítreo (1 o 2 dosis) o tratamiento fingido durante la participación en el estudio.
    -Evaluar los cambios en la presión intraocular tras las inyecciones intravítreas (1 o 2 dosis) o tratamiento fingido durante la participación en el estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients diagnosed of dry or wet ARMD, who completed the clinical trial with protocol code OFT-ethamsylate-4.2.1
    -Able and in agreement to follow the study protocol and to give the inform consent.
    Inclusion criteria to provide treatment with intravitreal ethamsylate in the same "treated eye" in the clinical trial:
    -Patients who show "no response to treatment" (lose 15 or more letters in the ETDRS chart) in the "treated eye" in the trial between weeks 4 and 16 after administration of the double-blinded treatment.
    -Based on investigator judgment is the most appropriate treatment option.
    Inclusion criteria to provide treatment with intravitreal ethamsylate in the contralateral eye:
    - Patients who show "treatment response" (lost 14 or fewer letters in the ETDRS chart) in the "treated eye" in the clinical trial at 16 weeks
    -The contralateral eye (untreated in the clinical trial) has a dry or wet ARMD, diagnosed later than the previous two years
    -Grade 5 ARMD.
    -The best visual acuity correted between 20/25 and 20/320, evaluated with optotype ETDRS
    -Not present any ocular pathology, based on investigator judgment could interfere in the development, evolution and evaluation of ARMD as glaucoma, permanent structural damage in central foveal, parafoveolar geographic atrophy, choroidal vasculopathy Polypoidal, so on.
    -Pacientes con DMAE seca o exudativa, que han finalizado el ensayo clínico con código de protocolo OFT-ETAMSILATO-4.2.1.
    -Pacientes con capacidad y voluntad para seguir el protocolo del estudio y que otorguen su Consentimiento Informado.
    Criterios de inclusión para administrar tratamiento con etamsilato intravítreo en el mismo "ojo tratado" en el ensayo clínico:
    -Pacientes que muestren una "no respuesta al tratamiento" (pierden 15 o más letras en el optotipo ETDRS) en el "ojo tratado" en el ensayo clínico entre las semanas 4 y 16 tras la administración del tratamiento doble enmascarado.
    -Que según el juicio clínico del investigador del estudio sea la opción terapéutica más adecuada.
    Criterios de inclusión para administrar tratamiento con etamsilato intravítreo en el ojo contralateral:
    -Pacientes que muestren una "respuesta al tratamiento" (pierden 14 o menos letras en el optotipo ETDRS) en el "ojo tratado" en el ensayo clínico en la semana 16 de haber sido administrado.
    -Que el ojo contralateral (no tratado en el ensayo clínico) tenga una DMAE seca o exudativa, diagnosticada en el plazo máximo de los dos años previos
    -Que el ojo contralateral tenga una DMAE menor a un 5º grado.
    -Que el ojo contralateral tenga una mejor agudeza visual corregida entre 20/25 y 20/320, evaluada mediante el optotipo ETDRS (Early Treatment Diabetic Retinopathy Study).
    -Que el ojo contralateral NO presente alguna patología ocular que, a juicio del investigador pueda influir en el desarrollo, evolución o valoración de la DMAE, como glaucoma, daños estructurales permanentes en el centro de la fóvea, atrofia geográfica parafoveolar, vasculopatía coroidea polipoidal, etc.
    E.4Principal exclusion criteria
    -Patients with concomitant illness that, based on the investigator judgment, could interfere (due to the disease itself or due to the associate treatment) in the development, evolution or evaluation of the ARMD, as diabetes mellitus with ocular affectation, active or ongoing systemic infection, any other ocular infection, psychiatric alterations, social situation, which could interfere in the compliance with the study requirements and so on.
    -Pregnant or breast-feeding-
    -Patients at week 16 of the previous clinical trial show "treatment response" (losing 14 or Afewer letters in the ETDRS chart) in the "treated eye", only a non-interventionist track that eye will be performed until week 48 after treatment delivery.
    -Pacientes con enfermedades concomitantes que, a juicio del investigador puedan influir (por la enfermedad en sí y/o sus tratamientos) en el desarrollo, evolución o valoración de la DMAE, como diabetes mellitus con afectación ocular, infección sistémica en curso o activa, cualquier infección ocular, trastornos psiquiátricos, situaciones sociales que puedan afectar al cumplimiento con los requisitos del estudio, etc.
    -Mujeres embarazadas o en periodo de lactancia.
    -En pacientes que en la semana 16 del ensayo clínico previo muestren "respuesta al tratamiento" (perder 14 o menos letras en el optotipo ETDRS) en el "ojo tratado", sólo se realizará un seguimiento no intervencionista de ese ojo hasta la semana 48 tras la administración del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Criteria for evaluation of effectiveness
    -Rate of success of treatment for treated eyes in the 4,16,24,36 weeks after the double blinded treatment (with or without second injection) or after the open and active treatment of the contralateral eye.
    -Rate of success of treatment for treated eyes in the 4,16,24,36 weeks after the double blinded treatment (with or without second injection) or after the open and active treatment of the contralateral eye.
    -Time to the disappearance of the response.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the best visual acuity corrected with the ETDRS optotype and using logarithmic value (logMAR) equivalent to the number of letters correctly read.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the number of letters correcltly read (counting form the upper left corner) with the ETDR optotype.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the best visual acuity corrected obtained with the Snellen optotype and using logMAR adjusted to the total number of letters correctly read.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the thickness in the central part of the macula measured by OCT.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the number of focused areas of pigment epithelium disappearance measures with OCT.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the number, location, area and volume of the drusen measured by microperimetry.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the number, location, area and volume of the drusen measured by OCT and colored retinography.
    -Evolution of the treated eyes from baseline visit up to weeks 4, 16, 24, 36 and 48 (regarding the administration of the double-blinded treatment or for open and active treatment of the contralateral eye) of the sensitivity to contrast determined by Pelli-Robson optotype.
    -Evolution of patient quality of life measured with th Visual Function Questionnaire-25 of the National Eye Institute (VFQ-25) and the EuroQoL 5 dimensiones (EQ-5D)

    Although the criteria for assessing the effectiveness take as a unit the treated eyes, analyzes were performed using both the patient and the eyes treated as the unit of analysis-
    Criterios de valoración de la eficacia:
    -Proporción de ojos tratados que presenten "éxito del tratamiento" en las semanas 4, 16, 24, 36 y 48 tras el tratamiento doble enmascarado (con o sin segunda inyección) o tras el tratamiento abierto y activo del ojo contralateral.
    -Proporción de ojos tratados que presenten "respuesta del tratamiento" en las semanas 4, 16, 24, 36 y 48 tras el tratamiento doble enmascarado (con o sin segunda inyección) o tras el tratamiento abierto y activo del ojo contralateral.
    -Tiempo transcurrido hasta la desaparición de la respuesta.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) de la mejor agudeza visual corregida determinada mediante el optotipo ETDRS y expresada en unidades logarítmicas decimales negativas del ángulo de resolución mínimo (logMAR) equivalentes al número de letras leídas correctamente.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) del número de letras leídas correctamente (contadas desde la esquina superior izquierda) en el optotipo ETDRS.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) de la mejor agudeza visual corregida determinada mediante el optotipo Snellen y expresada en unidades logMAR ajustadas al número total de letras leídas correctamente.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) del grosor de la parte central de la mácula medido mediante OCT.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) del número de áreas focalizadas de desaparición del epitelio pigmentario de la retina medidas mediante OCT.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) del tamaño del escotoma medido mediante microperimetría.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) del número, localización, área y volumen de las drusas medido mediante OCT y retinografía en color.
    -Evolución de los ojos tratados desde la visita basal a las semanas 4, 16, 24, 36 y 48 (respecto a la administración del tratamiento doble enmascarado o respecto al tratamiento abierto y activo del ojo contralateral) de la sensibilidad al contraste determinado mediante optotipo de Pelli-Robson.
    -Evolución de la calidad de vida de los pacientes medida con el cuestionario de la Función Visual-25 del National Eye Institute (VFQ-25) y con el cuestionario EuroQoL 5-Dimensiones 5-niveles (EQ-5D-5L), desde la visita basal del ensayo clínico aleatorizado hasta la semana 48 del último seguimiento o la última visita disponible.

    Aunque los criterios de valoración de la eficacia tomen como unidad los ojos tratados, los análisis se realizarán empleando tanto al paciente como a los ojos tratados como unidad de análisis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16- 48 weeks
    16-48 semanas
    E.5.2Secondary end point(s)
    Criteria for evaluation of safety:
    -Incidence of serious and severe adverse events related with the intravitreal ethamsylate during the participation in the extension study.
    -Evolution of intraocular pressure in treated eyes during the participation in the extension study.
    Criterios de valoración de la seguridad:
    -Incidencia de acontecimientos adversos según su severidad, gravedad y relación con etamsilato intravítreo en todos los pacientes durante su participación en el estudio de extensión.
    -Evolución de la presión intraocular en los ojos tratados durante la participación en el estudio de extensión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treated Eye. week 4 to week 16
    No treated Eye: Week 16-week 48
    Ojo tratado: Semana 4 a la 16
    Ojo no tratado: semana 16 a semana 48
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    última visita del último paciente
    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 months5
    E.8.9.1In the Member State concerned days
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state160
    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)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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