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    Summary
    EudraCT Number:2010-024512-34
    Sponsor's Protocol Code Number:C-10-040
    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:2011-09-01
    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 number2010-024512-34
    A.3Full title of the trial
    Seguridad y eficacia en la reducción de la presión intraocular de gotas oculares de combinación fija de brinzolamida 10 mg/ml / brimonidina 2 mg/ml, suspensión en comparación con gotas oculares de brinzolamida de 10 mg/ml, suspensión y gotas oculares de Brimonidina 2 mg/ml, solución, en pacientes con glaucoma de ángulo abierto o hipertensión ocular / Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL
    Fixed Combination Eye Drops, Suspension compared to Brinzolamide 10 mg/mL Eye
    Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients with
    Open-Angle Glaucoma or Ocular Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Seguridad y eficacia en la reducción de la presión intraocular de BrinzBrim en comparación con brinzolamida y brimonidina dadas por separado en pacientes con hipertensión ocular o con cambios en el nervio del ojo (glaucoma) /Safety and eye pressure lowering effect of Brinz/Brim, compared to Brinzolamide and Brimonidine given separately in patients with ocular hypertension or with associated changes to the nerve inside the eye (glaucoma).
    A.3.2Name or abbreviated title of the trial where available
    Brinz/Brim BID FC vs Brinzolamide BID and Brimonidine BID in Patients
    A.4.1Sponsor's protocol code numberC-10-040
    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 SponsorAlcon Research, Ltd.
    B.1.3.4CountryUnited States
    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 supportAlcon Research, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlcon Cusí S.A.
    B.5.2Functional name of contact pointElena Simo
    B.5.3 Address:
    B.5.3.1Street AddressC/camil Fabra 58
    B.5.3.2Town/ cityEl Masnou - Barcelona
    B.5.3.3Post code08320
    B.5.3.4CountryUnited States
    B.5.4Telephone number934977013
    B.5.5Fax number934977023
    B.5.6E-mailelena.simo@alconlabs.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 nameBrinzolamida 10 mg/ml / Brimonidina 2 mg/ml colirio en suspensión.
    D.3.2Product code 115576
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRINZOLAMIDA
    D.3.9.1CAS number 138890-62-7
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRIMONIDINA TARTRATO
    D.3.9.1CAS number 79570-19-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 AZOPT 10 mg/ml colirio en suspensión
    D.2.1.1.2Name of the Marketing Authorisation holderALCON LABORATORIES LTD. (UK)
    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 Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRINZOLAMIDA
    D.3.9.1CAS number 138890-62-7
    D.3.9.3Other descriptive nameBRINZOLAMIDE
    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 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 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 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 nameBrimonidina Tartrato 2 mg/ml Colirio en solución
    D.3.2Product code 101461
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Ocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBRIMONIDINA TARTRATO
    D.3.9.1CAS number 79570-19-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 de angulo abierto o hipertensión ocular/ Open-angle glaucoma or ocular hypertension
    E.1.1.1Medical condition in easily understood language
    Presion elevada en el ojo (hipertensión ocular) o daños en el nervio óptico (glaucoma) / Elevated pressure in the eye with (ocular hypertension) or without optic nerve damages (glaucoma)
    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 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
    Brinzolamida de 10 mg/ml / brimonidina 2 mg/ml, colirio en suspensión es superior a brinzolamida de 10 mg/ml, colirio en suspensión, con respecto a la eficacia para la reducción de la PIO; y brinzolamida 10 mg/ml / brimonidina 2 mg/ml, colirio en suspensión es superior a brimonidina 2 mg/ml, colirio en solución, con respecto a la eficacia para la reducción de la PIO -
    Brinzolamide 10 mg/mL / brimonidine 2 mg/mL eye drops, suspension is superior to brinzolamide 10 mg/mL eye drops, suspension, with respect to IOP-lowering efficacy, and brinzolamide 10 mg/mL / brimonidine 2 mg/mL eye drops, suspension is superior to brimonidine 2 mg/mL eye drops, solution, with respect to IOP-lowering efficacy
    E.2.2Secondary objectives of the trial
    No hay objetivos secundarios. There are no secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes de 18 años de edad o más, de ambos sexos y cualquier raza/etnicidad, diagnosticados de glaucoma de ángulo abierto o hipertensión ocular que, a criterio del investigador, carecen de control suficiente en la monoterapia o ya reciben medicación múltiple para reducir la PIO.
    2. Los pacientes deben estar en condiciones de entender y firmar un consentimiento informado, aprobado por un Comité Ético.
    3. Las medidas de PIO media en 1 ojo, en almenos un ojo el mismo ojo (o los mismos ojos), deben ser:
    > o = 24 mmHg y < o = 36 mmHg en el punto de tiempo de las 9 de la mañana
    > o = 21 mmHg y < o = 36 mmHg en el punto de tiempo de las 11 de la mañana en las Visitas de elegibilidad 1 y elegibilidad 2.
    La PIO media no debe ser > 36 mmHg en ningún punto
    1. Patients 18 years of age or older, of either gender, and any race/ethnicity, diagnosed with open angle glaucoma or ocular hypertension, who in the opinion of the Investigator are insufficiently controlled on monotherapy or are already on multiple IOP-lowering medications.
    2. Patients should be able to understand and sign an informed consent that has been approved by an Institutional Review Board/Independent Ethics Committee.
    3. Mean IOP measurements in at least 1 eye, the same eye(s), must be:
    > o = 24 mmHg and < o = 36 mmHg at the 9 AM time point and,
    > o = 21 mmHg and < o = 36 mmHg at the 11 AM time point at both E1 and E2 Visits.
    E.4Principal exclusion criteria
    1 Mujeres en edad fértil (las que no han sido esterilizadas quirúrgicamente o posmenopáusicas durante 1 año como mínimo) se excluyen de la participación en el estudio si cumplen cualquier condición de las siguientes
    a.están embarazadas o,
    b. dan resultado positivo en la prueba de embarazo de orina en la visita de selección o,
    c. tienen la intención de quedarse embarazadas durante el período del estudio o,
    d. están en período de lactancia o,
    e. no están usando medidas anticonceptivas de alta efectividad, como:
    contraceptivos hormonales:
    orales, implantados, transdérmicos o inyectados;
    contraceptivos mecánicos:
    espermicida junto con una barrera como un condón, diafragma o DIU.
    2. Los pacientes con grado de ángulo de Schaffer < 2, medido por gonioscopia (ángulo extremadamente angosto con oclusión total o parcial).
    3. Pacientes con relación copa/disco (C/D) superior a 0,80 (medida horizontal o vertical).
    4. Pacientes con pérdida severa del campo visual central. La pérdida severa del campo visual central se define como una sensibilidad menor o igual a 10 dB en al menos 2 de los 4 puntos de prueba del campo visual más cercanos al punto de fijación.
    5. Pacientes que no pueden interrumpir de forma segura el uso de toda la medicación ocular para reducir la PIO durante un período mínimo de 5 días ± 1 día hasta 28 días ± 1 día antes de la visita E1.
    6. Retinopatía inflamatoria crónica, recurrente o severa (o sea, escleritis, uveitis, queratitis herpética).
    7. Trauma ocular en los últimos 6 meses.
    8. Infección ocular o inflamación ocular en los últimos 3 meses.
    9. Retinopatía clínicamente significativa o progresiva, como degeneración retinal, retinopatía diabética o desprendimiento de la retina.
    10. Un resultado de agudeza visual mejor corregida (BCVA) de menos de 55 letras ETDRS (equivalente a aproximadamente 20/80 Snellen, 0,60 logMAR, o 0,25 decimal).
    11. Otras patologías oculares (entre ellas ojo seco severo) que, a criterio del investigador, son susceptibles de impedir la administración de agonista alfa-andrenérgico y/o inhibidor de anhidrasa carbónica tópica (CAI).
    12. Cirugía intraocular en los últimos 6 meses.
    13. Cirugía ocular láser en los últimos 3 meses
    14. Cualquier anomalía que impida una tonometría de aplanación fiable
    15. Cualquier otro estado, incluso enfermedades que, a criterio del investigador, harían que el paciente no fuera adecuado para el estudio.
    16. Historial de enfermedad cardiovascular (insuficiencia coronaria, hipertensión, fenómeno de Raynaud, hipotensión ortostática, tromboanginitis obliterante, cerebrovascular (insuficiencia cerebral), hepática o renal, de carácter activo, severo, inestable o no controlada que, a criterio del investigador, impediría la administración segura de un agonista alfa-adrenérgico tópico o de un inhibidor de anhidrasa carbónica.
    17. Pacientes con uso reciente (en las 4 semanas que preceden la visita de elegibilidad 1) de terapia de salicilato en dosis altas (> 1 g diario).
    18. Tratamiento actual o previsto con cualquier fármaco psicotrópico que aumente la respuesta adrenérgica (desipramina, amitriptilina).
    19. Uso simultaneo de inhibidores de monoamino oxidasa.
    20. Terapia con otro agente de investigación dentro de los 30 días anteriores a la visita de selección.
    21. Hipersensibilidad a los fármacos agonistas alfa-adrenérgicos, inhibidores de anhidrasa carbónica tópicos u orales, derivados de sulfonamida o a cualquier componente de la medicación del estudio, a criterio del investigador.
    22. Menos de 30 días de régimen de dosificación estable antes de la visita de selección, de medicación o sustancias administradas por cualquier vía y usadas de forma crónica, que pueda afectar la PIO incluyendo pero sin limitación, agentes bloqueadores &#946;-adrenérgicos.
    23. Uso de una medicación hipotensiva ocular tópica o sistémica adicional durante el estudio.
    24. Uso simultaneo de glucocorticoides administrados por cualquier vía.
    El monitor médico puede declarar no adecuado a cualquier paciente por un motivo médico válido.

    1. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the studyif they meet any one of the following conditions:
    a. are currently pregnant or,
    b. have a positive result on the urine pregnancy test at the Screening Visit or,
    c. intend to become pregnant during the study period or,
    d. are breast-feeding or,
    e. they are not using highly effective birth control measures, such as:
    Hormonal oral, implanted, transdermal, or injected contraceptives;
    Mechanical spermicide in conjunction with a barrier such as a condom or diaphragm or IUD.
    2. Patients with Schaffer angle Grade < 2, as measured by gonioscopy (extreme narrow angle with complete or partial closure).
    3. Patients with a cup/disc ratio (C/D) greater than 0.80 (horizontal or vertical measurement).
    4. Patients with severe central visual
    E.5 End points
    E.5.1Primary end point(s)
    Eficacia Primaria:
    Cambio de la PIO diurna media desde el valor inicial (mes 3).
    Eficacia de apoyo:
    Cambio de la PIO diurna media desde el valor inicial (semana 2, semana 6 y mes 6)
    PIO media (semana 2, semana 6, mes 3 y mes 6)
    Cambio de la PIO media desde el valor inicial (semana 2, semana 6, mes 3 y mes 6)
    Cambio porcentual de la PIO media desde el valor inicial (semana 2, semana 6, mes 3 y mes 6)
    Porcentaje de pacientes con PIO < 18 mmHg en cada visita en terapia y punto de tiempo (semana 2, semana 6, mes 3 y mes 6).
    Seguridad: Paquimetría, parámetros de fondo del ojo, BCVA (agudeza visual mejor corregida), examen de lámpara de hendidura, perimetría automatizada estándar, pulso / presión sanguínea, acontecimientos adversos.
    Primary Efficacy:
    Mean diurnal IOP change from baseline (Month 3).
    Supportive Efficacy:
    Diurnal IOP change from baseline (Week 2, Week 6, Month 6)
    IOP (Week 2, Week 6, Month 3, Month 6)
    IOP change from baseline (Week 2, Week 6, Month 3, Month 6)
    IOP % change from baseline (Week 2, Week 6, Month 3, Month 6)
    Percentage of patients with IOP < 18 mmHg at each ontherapy visit and time point (Week 2, Week 6, Month 3, Month 6).)
    Safety: Pachymetry, fundus parameters, BCVA, slit-lamp exam, standard automated perimetry, pulse / blood pressure, Gonioscopy, adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Average other 9 AM + 2Hrs, + 7Hrs and + 10 Hrs (this last time point will be collected at only same selected sites).
    E.5.2Secondary end point(s)
    No procede
    E.5.2.1Timepoint(s) of evaluation of this end point
    No procede
    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) 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 No
    E.8.1.4Double blind Yes
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Australia
    Brazil
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Mexico
    New Zealand
    Portugal
    Singapore
    Spain
    Taiwan
    Thailand
    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
    Última visita del último sujeto.
    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 months7
    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 months8
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 275
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 525
    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)
    Post trial treatment or care will not be different from the expected normal treatment of that condition
    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 Decision2011-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
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