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    Summary
    EudraCT Number:2009-015386-30
    Sponsor's Protocol Code Number:GLP108486
    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:2009-10-27
    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 number2009-015386-30
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, abierto, de grupos paralelos y controlado con tratamiento activo para determinar la seguridad y la eficacia de la albiglutida administrada en combinación con insulina glargina en comparación con la combinación de insulina glargina e insulina lispro preprandial en sujetos con diabetes mellitus de tipo 2.

    A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared with the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus
    A.4.1Sponsor's protocol code numberGLP108486
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSmithKline Beecham Corporation (doing business as GlaxoSmithKline)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAlbiglutida
    D.3.2Product code GSK716155
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGSK716155
    D.3.9.3Other descriptive nameAlbiglutida
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 nameAlbiglutida
    D.3.2Product code GSK716155
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGSK716155
    D.3.9.3Other descriptive nameAlbiglutida
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Humalog
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameHumalog
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULINA LISPRO
    D.3.9.1CAS number 133107-64-9
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 4
    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 Lantus
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameLantus
    D.3.2Product code A10A E04
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulina glargina
    D.3.9.1CAS number 160337951
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Diabetes melitus de tipo 2.

    Type 2 Diabetes Mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del estudio es evaluar la eficacia de la albiglutida en combinación con insulina glargina en comparación con la combinación de insulina glargina e insulina lispro preprandial sobre la variación de la HbA1c en la semana 26 con respecto al valor basal.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de la eficacia en los puntos temporales que se especificarán en el plan de análisis estadístico (PAE) comprenden las siguientes evaluaciones del tratamiento con albiglutida en combinación con insulina glargina en comparación con la combinación de insulina glargina e insulina lispro preprandial:
    • Variación de la HbA1c con respecto al valor basal a lo largo del tiempo.
    • Variación de la glucemia en ayunas (GA) con respecto al valor basal a lo largo del tiempo.
    • Proporción de sujetos que presentan el objetivo terapéutico de la HbA1c de < 7,0 %.
    • Proporción de sujetos que presentan el objetivo terapéutico de la HbA1c de < 6,5 %.
    • Tiempo hasta el rescate en caso de hiperglucemia.
    • Variaciones del peso corporal con respecto al valor basal.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Estudio farmacogenético en relación con GLP108486.
    • Relación entre las variantes genéticas y la farmacocinética del producto en investigación.
    • Relación entre las variantes genéticas y la seguridad o tolerabilidad del producto en investigación.
    • Relación entre las variantes genéticas y la eficacia del producto en investigación.
    E.3Principal inclusion criteria
    Podrán participar en el estudio los sujetos que cumplan todos los criterios siguientes:
    1. Varones o mujeres, de 18 a 75 años de edad, inclusive, con un diagnóstico histórico de diabetes mellitus de tipo 2 y que estén recibiendo tratamiento con insulina glargina o con otra insulina de acción intermedia o prolongada, con o sin antidiabéticos orales, pero que presenten un control insuficiente de la glucemia y que estén dispuestos a y sean capaces de participar en un tratamiento intensivo de insulina. Todo sujeto que haya recibido una insulina de acción intermedia o prolongada durante > ó = 6 meses pero < 5 años y que, a pesar de que se le haya ajustado la dosis en función del control domiciliario de la glucemia, no pueda alcanzar un valor de HbA1c < 7 %. Estos sujetos deben ser capaces y estar dispuestos a cambiar el tratamiento sencillo con insulina basal por un tratamiento intensificado.
    2. IMC > ó = 20 kg/m2 y < ó = 45 kg/m2.
    3. Péptido C en ayunas > ó = 0,8 ng/ml (> ó = 0,26 nmol/l).
    4. HbA1c entre el 7,0 % y el 10,5 %, inclusive, en la visita 5 (semana -1). El valor de HbA1c puede medirse hasta cuatro veces, y si el promedio de estas mediciones cumple el criterio, podrá asignarse aleatoriamente al sujeto para recibir tratamiento.
    5. Para el uso regular de otros fármacos (no se incluyen los medicamentos excluidos por el protocolo [véase el apartado 5.6.2; por ejemplo, se excluyen los medicamentos para perder peso]), es preferible que los sujetos estén recibiendo una dosis estable durante al menos cuatro semanas antes de la selección; sin embargo, según sea necesario durante el período de preinclusión y durante el período de tratamiento, se permitirá el uso de medicamentos de venta con receta o sin receta, que podrán ser ajustados por el investigador para optimizar el tratamiento (por ejemplo, aumento o disminución de fármacos para el tratamiento de la presión arterial o la hiperlipidemia de acuerdo con la práctica médica local aceptada y documentos de referencia relevantes).
    6. En general no se permite el uso de glucocorticoides orales o inyectados por vía sistémica en los tres meses previos a la aleatorización; sin embargo, podrán permitirse ciclos breves de esteroides orales (dosis única o dosis múltiples durante un máximo de dos días) siempre que se comenten estos casos con el monitor médico. Se permitirá el uso de corticosteroides inhalatorios, intraarticulares y tópicos.
    7. Hemoglobina > ó = 11 g/dl (> ó = 110 g/l) en los varones y > ó = 10 g/dl (> ó = 100 g/l) en las mujeres.
    8. Aclaramiento de creatinina > 60 ml/min (calculado con la fórmula de Cockcroft-Gault).
    9. La concentración de hormona estimulante del tiroides es normal o clínicamente eutiroidea, demostrada por pruebas tiroideas adicionales (por ejemplo, T4, T3, globulina transportadora de tiroxina).
    10. Las mujeres con capacidad de procrear (es decir, que no hayan sido esterilizadas quirúrgicamente ni sean posmenopáusicas) deberán estar utilizando métodos anticonceptivos adecuados. Los métodos anticonceptivos adecuados son: abstinencia, progestágeno inyectable, implantes de levonorgestrel, anillo vaginal estrogénico, parches anticonceptivos percutáneos, dispositivo o sistema intrauterino, esterilización de la pareja masculina (vasectomía con documentación de azoospermia) antes de la incorporación de una mujer al estudio, siendo dicha pareja masculina la única pareja de esa mujer, método de doble barrera (preservativo o capuchón oclusivo más nonoxinol-9) o anticonceptivos orales en combinación con un segundo método anticonceptivo (p. ej., preservativo y capuchón oclusivo). La anticoncepción adecuada deberá practicarse durante toda la participación en el estudio, incluido el período de seguimiento después del tratamiento de ocho semanas.
    11. Capacidad y disposición para vigilar las concentraciones de glucemia con un monitor domiciliario de la glucemia conforme a las recomendaciones de autoadministración establecidas en el protocolo.
    12. Ausencia de enfermedades o debilidades importante que, en opinión del investigador, impidan al sujeto participar activamente en el control de su diabetes y completar el estudio.
    13. Capacidad y disposición para otorgar el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Antecedentes de cáncer, distinto de un carcinoma espinocelular o basocelular cutáneo, que no haya estado en remisión completa durante al menos 3 años antes de la selección. (Se permitirán los antecedentes de neoplasia intraepitelial cervical I o II tratada)
    2. Antecedentes de gastroparesia diabética tratada.
    3. Enfermedad biliar sintomática en curso o antecedentes de pancreatitis.
    4. Antecedentes de cirugía gastrointestinal importante, como derivación gástrica y colocación de bandas elásticas, antrectomía, derivación en Y de Roux, vagotomía gástrica, resección del intestino delgado o intervenciones que se piensa que afectan significativamente a la función gastrointestinal superior.
    5. Enfermedades cardiovasculares o cerebrovasculares con importancia clínica recientes. (Para información más detallada véase el protocolo).
    6. Antecedentes de ictus u otros trastornos del sistema nervioso central que afectarían negativamente a la capacidad del sujeto para participar en un programa de tratamiento intensivo con insulina (por ejemplo, incapacidad física o mental para realizar el control domiciliario de la glucemia o de administrarse o ajustar la dosis de insulina).
    7. Hemoglobinopatía que puede afectar a la determinación de la HbA1c.
    8. Antecedentes de infección por el virus de la inmunodeficiencia humana.
    9. Antecedentes de valores de bilirrubina total > 1,5 veces el LSN, a menos que el sujeto tenga antecedentes ya conocidos de síndrome de Gilbert y una bilirrubina fraccionada que revele una bilirrubina conjugada < 35 % de la bilirrubina total.
    10. ALT o aspartato-aminotransferasa (AST) > 2,5 × LSN .
    11. Concentración de triglicéridos en ayunas > 850 mg/dl en la visita de selección o en la Semana -1 (visita 5). Si la concentración de triglicéridos del sujeto es > 500 mg/dl en la visita de selección y en la semana -1, se excluirá al sujeto. Si el sujeto cumple los criterios de exclusión mencionados relativos a los triglicéridos, el sujeto podrá ser tratado y sometido a una nueva selección. Los sujetos tratados deberán recibir una dosis estable de medicación durante al menos cuatro semanas antes de someterse a una nueva selección .
    12. Infección sintomática aguda (en los tres meses anteriores a la selección) por el virus de la hepatitis B o C; sin embargo, se permitirá la participación de sujetos con hepatitis B o C antigua o crónica siempre que se cumplan los requisitos de ALT, AST y bilirrubina total.
    13. Antecedentes de un trastorno psiquiátrico que afectará a la capacidad del sujeto para participar en el estudio.
    14. Antecedentes de alcoholismo o drogadicción durante el año anterior a la selección.
    15. Análisis toxicológico en orina positivo en la visita de selección, a menos que el paciente esté tomando un fármaco prescrito para el que un resultado positivo simplemente verifique el uso del fármaco.

    Para los criterios de exclusión 16-24 véase el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    La evaluación principal será la variación de la HbA1c en la semana 26 con respecto al valor basal.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 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 months3
    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 months3
    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.1.3Elderly (>=65 years) Yes
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 500
    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)
    Según protocolo
    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 Decision2010-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-29
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