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    Summary
    EudraCT Number:2017-000846-23
    Sponsor's Protocol Code Number:LT4032-301
    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:2018-11-12
    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 number2017-000846-23
    A.3Full title of the trial
    Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.
    Evaluación de la eficacia y de la seguridad de T4032 (bimatoprost 0.01% sin conservar) frente a Lumigan® 0.01% en pacientes con hipertensión ocular o glaucoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous patients.
    Evaluación de la eficacia y de la seguridad de T4032 frente a Lumigan® en pacientes con hipertensión ocular o glaucoma
    A.3.2Name or abbreviated title of the trial where available
    In-SIGHT study
    Estudio de la VISIÓN
    A.4.1Sponsor's protocol code numberLT4032-301
    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 SponsorLaboratoires THEA
    B.1.3.4CountryFrance
    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 supportLaboratoires THEA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratoires THEA
    B.5.2Functional name of contact pointClinical department
    B.5.3 Address:
    B.5.3.1Street Address12, rue Louis Blériot
    B.5.3.2Town/ cityClermont-Ferrand cedex 2
    B.5.3.3Post codeF-63017
    B.5.3.4CountryFrance
    B.5.4Telephone number+ 33 4 73 98 14 36
    B.5.5Fax number+ 33 4 73 98 14 24
    B.5.6E-mailAude.BARDIOT@theapharma.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 No
    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.3.1Product nameBimatoprost
    D.3.2Product code T4032
    D.3.4Pharmaceutical form Eye gel in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeT4032
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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 Lumigan® 0.01 %
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.01
    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: 3
    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 Azopt®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    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
    glaucoma, ocular hypertension
    glaucoma, hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    over tension in the eye
    Exceso de tensión en el ojo
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    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 demonstrate the non-inferiority of T4032 unpreserved eye drops compared to Lumigan® 0.01% in terms of efficacy.
    Demostrar la no inferioridad en cuanto a la eficacia del colirio de T4032 sin
    conservantes frente a Lumigan® al 0,01 %.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of T4032 versus Lumigan® 0.01%.
    Evaluar la seguridad y la eficacia de T4032 frente a Lumigan® al 0,01 %.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Screening Visit (D-42):
    -Informed consent signed and dated.
    -Patient aged ≥18 years old.
    -Both eyes with 500 µm ≤ central corneal thickness ≤ 600 µm.
    -Both eyes with diagnosed open-angle glaucoma or ocular hypertension, initially treated and controlled (including IOP ≤ 18 mmHg) for at least 6 months by any prostaglandin monotherapy.
    -Both eyes with IOP ≤ 18 mmHg.

    At Randomisation Visit (D1) at 8:00:
    -Both eyes with 22 mmHg ≤ IOP < 34 mmHg and with asymmetry between eyes ≤ 3 mmHg.
    En la visita de selección (D−42):
    -Consentimiento informado firmado y fechado.
    -Paciente de 18 o más años de edad.
    -500 μm ≤ espesor corneal central ≤ 600 μm en ambos ojos.
    -Diagnóstico en ambos ojos de glaucoma primario de ángulo abierto
    o hipertensión ocular, inicialmente tratados y controlados (incluida
    una PIO ≤ 18 mmHg) durante un mínimo de seis meses con cualquier
    prostaglandina en monoterapia.
    - PIO ≤ 18 mmHg en ambos ojos.

    En la visita de aleatorización (D1) a las 8:00:
    -22 mmHg ≤ PIO < 34 mmHg y asimetría entre ojos ≤ 3 mmHg en
    ambos ojos.
    E.4Principal exclusion criteria
    Ophthalmic Exclusion Criteria in AT LEAST ONE EYE:
    -Fundus examination not performed or not available within 12
    months.
    -Visual field not performed or not available within 12 months.
    - Significant worsening according to the two last visual fields (at
    least 6 months between the two visual fields).
    -Advance stage of glaucoma, defined by at least one of the following criteria:
    - Absolute defect in the ten degrees central point of the visual field.
    - Severe visual field loss: MD < -18 dB.
    -Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement.
    -History of non-responder to bimatoprost therapy.
    -Far Best Corrected Visual Acuity ≥ + 0.7 Log Mar (e.g., ≤ 0.2 in decimal value or ≤ 20/100 Snellen equivalent or ≤ 50 ETDRS letters).
    -History of trauma, infection, clinically significant inflammation
    within the 3 previous months.
    -Ongoing or known history of ocular allergy and/or uveitis
    and/or viral infection.
    -Clinically significant or progressive retinal disease (e.g. retinal
    degeneration, diabetic retinopathy, retinal detachment).
    -Presence of at least one severe objective sign among the following:
    -Conjunctival hyperaemia (Grade 5 / McMonnies
    scale).
    -Superficial punctate keratitis (Grade 4/5 / Oxford
    scale).
    - Blepharitis (Grade 3 / 0-3 scale).
    - Severe dry eye as assessed by the investigator.
    - Corneal ulceration.
    -Any palpebral abnormality incompatible with a good
    examination.
    -Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.

    Regarding Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions and Exclusion Criteria Related to Previous and Concomitant Treatments (Medications/Non-Medicinal Therapies/Procedures) please refer to the study protocol in page 28.
    Criterios de exclusión de carácter oftálmico EN AL MENOS UN OJO:
    -Fondo de ojo no medido o no disponible en los 12 meses previos.
    -Campo visual no medido o no disponible en los 12 meses previos.
    -Deterioro significativo según los dos últimos campos visuales (al
    menos seis meses entre los dos campos visuales).
    -Estadio avanzado del glaucoma, definido como mínimo por uno de
    los siguientes criterios:
    -Déficit absoluto en los diez grados centrales del campo
    visual.
    -Pérdida marcada del campo visual: MD < −18 dB.
    -Riesgo de deterioro del campo visual como resultado de la
    participación en este estudio, según el mejor criterio del
    investigador.
    -Antecedentes de falta de respuesta al tratamiento con bimatoprost.
    -Mejor agudeza visual corregida ≥ + 0,7 LogMar (p. ej., ≤ 0,2 en valor
    decimal o ≤ 20/100 en equivalente en Snellen o ≤ 50 letras ETDRS).
    -Antecedentes de traumatismo, infección o inflamación en los 3 meses
    previos a la visita de inclusión.
    -Alergia ocular, infección vírica o uveítis en curso o antecedentes
    confirmados.
    -Afección retiniana clínicamente significativa o progresiva (p. ej.,
    degeneración retiniana, retinopatía diabética, desprendimiento de
    retina).
    -Presencia de al menos uno de los siguientes signos objetivos graves:
    -Hiperemia conjuntival (grado 5 / escala de McMonnies).
    -Queratitis punteada superficial (grado 4/5 / escala de Oxford).
    -Blefaritis (grado 3 / escala de 0-3).
    -Sequedad ocular intensa a juicio del investigador.
    - Úlcera corneal.
    -Cualquier anomalía palpebral incompatible con una buena
    exploración.
    -Cualquier otra anomalía que podría interferir con la fiabilidad de las
    exploraciones, tales como, por ejemplo, la tonometría de aplanación,
    la exploración del campo visual o la exploración del fondo del ojo.

    En relación a los criterios de exclusión de carácter sistémico/no oftálmico, criterios de exclusión específicamente relacionados con las mujeres
    potencialmente fértiles, criterios de exclusión relativos a factores de carácter general y Criterios de exclusión relacionados con los tratamientos previos y
    concomitantes (medicamentos/procedimientos/tratamientos no farmacológicos) por favor consulte el estudio del protocolo en la página 28.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (Day 1) to Week 12 in IOP at the three time points (8:00 am; 10:00 am; 4:00 pm) in the worse eye.
    Cambio desde la situación inicial (Día 1) a la semana 12 en la PIO en los tres
    puntos temporales (8:00 am, 10:00 am y 4:00 pm) en el ojo contralateral.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 timepoints (8:00 am; 10:00 am; 4:00 pm) at Visit#2 (Day 1), Visit 3 (week 6) and visit 4 (week 12)
    3 puntos temporales (8:00 am, 10:00 am y 4:00 pm) en la visita 2 (Dia 1), visita 3 (semana 6) y visita 4 (semana 12)
    E.5.2Secondary end point(s)
    Efficacy secondary Endpoints:
    Change from baseline to Week 12 in IOP at the three time points (8:00, 10:00 and 16:00) in the contralateral eye.
    Others efficacy endpoints will be analysed:
    - Change from baseline to Week 6 in IOP at the three time points (8:00; 10:00; 16:00) in the worse eye and in the contralateral eye.
    - Efficacy assessed by the investigator.

    Safety Endpoints:
    -Conjunctival hyperaemia on McMonnies scale at Week 6 and Week 12.
    -Change from baseline of the conjunctival hyperaemia on McMonnies scale in 3 classes (improvement, no change, worsening) at Week 6 and Week 12.
    -Score of each ocular symptom throughout the day and the sum of these scores.
    -Score of each ocular symptom upon instillation and the sum of these scores.
    -Score of each ocular sign.
    -Corneal fluorescein staining (Oxford grading scheme).
    -Far Best Corrected Visual Acuity expressed in Log MAR.
    -Ocular tolerance assessed by the investigator.
    -Ocular tolerance assessed by the patient.
    -Ocular and systemic AE by System Organ Class and Preferred Term.
    Variables Secundarias de Eficacia:
    Cambio desde la situación inicial a la semana 12 en la PIO en los tres puntos temporales (8:00, 10:00 y 16:00) en el ojo contralateral.
    Se analizarán otras variables de eficacia:
    -Cambio entre la situación inicial y la semana 6 en la PIO en los tres puntos temporales (8:00, 10:00 y 16:00), en el ojo más grave y el ojo contralateral.
    -Evaluación de la eficacia a juicio del investigador.

    Variables de seguridad:
    -Hiperemia conjuntival en la escala de McMonnies en la semana 6 y la semana 12.
    -Cambio desde la situación inicial de la hiperemia conjuntival en la escala de McMonnies en tres clases (mejoría, sin cambios, empeoramiento) en la semana 6 y la semana 12.
    -Puntuación de cada síntoma ocular a lo largo del día y la suma de estas puntuaciones.
    -Puntuación de cada síntoma ocular después de la instilación y la suma de estas puntuaciones.
    -Puntuación de cada signo ocular.
    -Tinción corneal con fluoresceína (esquema de clasificación de Oxford).
    -Mejor agudeza visual corregida expresada en LogMar.
    -Tolerancia ocular evaluada por el investigador.
    -Tolerancia ocular evaluada por el paciente.
    -AA oculares y sistémicos por grupo sistémico y término preferido.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy secondary Endppoints:
    Change from baseline to Week 12 in IOP at the three time points (8:00 am, 10:00 am and 4:00 pm) in the contralateral eye.
    Others efficacy endpoints will be analysed:
    - Change from baseline to Week 6 in IOP at the three time points (8:00 am; 10:00 am; 4:00 pm) in the worse eye and in the contralateral eye.
    - Efficacy assessed by the investigator.

    Safety Endpoints:
    Visit#2 (Day 1), Visit 3 (week 6) and visit 4 (week 12)
    Variables Secundarias de Eficacia:
    Cambio desde la situación inicial a la semana 12 en la PIO en los tres puntos temporales (8:00, 10:00 y 16:00) en el ojo contralateral.
    Se analizarán otras variables de eficacia:
    -Cambio entre la situación inicial y la semana 6 en la PIO en los tres puntos temporales (8:00, 10:00 y 16:00), en el ojo más grave y el ojo contralateral.
    -Evaluación de la eficacia a juicio del investigador.

    Variables de seguridad:
    Visita 2 (Día 1), visita 3 (semana 6) y visita 4 (semana 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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Investigador oculto
    Investigator-masked
    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 concerned100
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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
    Belgium
    Estonia
    France
    Germany
    Greece
    Italy
    Lithuania
    Poland
    Spain
    Tunisia
    Ukraine
    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 of the Last Subject
    Última Visita del Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 161
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 273
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 374
    F.4.2.2In the whole clinical trial 434
    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 Decision2018-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-24
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