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    Summary
    EudraCT Number:2009-013538-26
    Sponsor's Protocol Code Number:20080615
    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:2010-02-03
    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 number2009-013538-26
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to
    Determine the Safety and Efficacy of AMG 853 in Subjects with Inadequately Controlled Asthma
    ------------------------------
    Estudio de fase 2 de dosis múltiple, aleatorizado, a doble ciego y controlado con placebo para determinar la seguridad y la eficacia de AMG 853 en sujetos con asma mal controlado
    A.4.1Sponsor's protocol code number20080615
    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 SponsorAmgen Inc
    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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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 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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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) 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 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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inadequately Controlled Asthma
    -----------------------------------
    Asma mal controlado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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 es determinar si AMG 853 es eficaz en comparación con placebo, medido por los cambios en las puntuaciones de los síntomas del cuestionario de control del asma (ACQ) desde el nivel basal hasta la semana 12.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de AMG 853 a través de la valoración de:
    -Volumen espiratorio forzado previo y posterior al broncodilatador en 1 segundo (VEF1).
    -Flujo espiratorio máximo (FEM) matutino y vespertino.
    -Uso de agonistas beta; de acción corta (SABA) de rescate.
    -Puntuación diaria de síntomas (síntomas individuales y conjunto/diarios/nocturnos, y días sin síntomas).
    -Cuestionario de calidad de vida en el asma (AQLQ).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Hombres o mujeres de 18 a 65 años de edad en el momento de la selección.
    -Porcentaje de VEF1 >=50% y <=80% previsto en las visitas de selección y basal.
    Reversibilidad como mínimo del 12% sobre el VEF1 previo al broncodilatador con la inhalación de SABA (hasta 8 inhalaciones) o su equivalente en nebulizador (hasta 2 tratamientos con 2,5 mg de albuterol), que puede demostrarse en la consulta durante la selección.
    -Corticosteroides inhalados (CSI) >=200 y <=1.000 µg/día de fluticasona o un equivalente. Dosis estable de CSI durante >=30 días antes de la selección y uso de CSI durante al menos los últimos 3 meses consecutivos previos a la selección. Está previsto que la dosis de CSI se mantenga sin variaciones desde la selección hasta el final del estudio.
    -Síntomas de asma en curso con puntuación del ACQ basal y en la selección >=1,5 puntos.
    -Si está recibiendo inmunoterapia con alérgenos, dosis estable durante >3 meses antes de la selección y previsión de mantenerla estable durante todo el estudio.
    -No fumador o ex fumador con < 10 paquetes-años (es decir, 1 paquete por día durante 10 años) que dejó de fumar >= 1 año.
    -Ha firmado el consentimiento informado aprobado por el CRI antes de cualquier procedimiento específico del estudio.
    E.4Principal exclusion criteria
    -Exacerbación aguda del asma que requiere tratamiento de urgencia u hospitalización durante los 2 meses anteriores a la selección.
    -Antecedentes de intubación endotraqueal por exacerbación relacionada con el asma durante los 3 años anteriores a la selección.
    -Antecedentes de enfermedad pulmonar obstructiva crónica u otro trastorno pulmonar crónico diferente del asma.
    -Diagnóstico actual de apnea del sueño con síntomas en curso o necesidad de presión positiva continua en las vías respiratorias.
    -Antecedentes de asma sensible a aspirina.
    -Cualquier enfermedad sistémica no controlada y clínicamente significativa(p.ej.diabetes no controlada, hepatopatía).
    -Cualquier hallazgo en el ECG de la selección que según el investigador requiera seguir realizando pruebas cardiovasculares.
    -Hipertensión mal controlada, definida como tensión arterial en reposo >150/90 mmHg(evaluada en dos momentos del periodo de selección).
    -Síndromes de malabsorción conocidos(p.ej.úlcera duodenal activa, enfermedad intestinal inflamatoria, antecedentes de cirugía en el intestino delgado que implique resección o antecedentes de derivación gástrica).
    -Infección respiratoria en las 4 semanas anteriores a la visita de selección.
    -Cualquier indicio de infección activa en la visita de selección que requiera antibióticos sistémicos.
    -Neoplasia maligna(que no sea carcinoma cutáneo de células escamosas ni de células basales, ni cáncer cervical localizado tratado que se considere curado) en los 5 años anteriores a la visita de selección (si se produjo una neoplasia maligna >5 años antes, el sujeto se considerará elegible si aporta documentación de su estado sin enfermedad desde el tratamiento).
    -Corticosteroides sistémicos en las 6 semanas anteriores a la visita de selección.
    -Ha recibido agonistas beta; de acción prolongada, teofilina, anticolinérgicos inhalados, agonistas beta;2 orales o tratamiento con cromoglicato en la semana anterior a la primera visita de preinclusión.
    -Antagonistas de los leucotrienos en las 2 semanas anteriores a la primera visita de preinclusión.
    -Inhibidores de la 5-lipooxigenasa para el asma(p.ej.Zyflo®) en la semana anterior a la primera visita de preinclusión.
    -Administración previa de AMG 853.
    -Administración actual de cualquier producto biológico comercial o en investigación en la selección.
    -Xolair® en los 2 meses anteriores a la visita de selección.
    -Prueba cutánea de la tuberculina positiva o exposición reciente(durante los últimos 6 meses) a una persona con tuberculosis activa.
    Se permite la inclusión de sujetos con una prueba cutánea de la tuberculina positiva si:
    –Han completado el tratamiento con quimioprofilaxis adecuada, o
    –Tienen antecedentes de vacunación con el bacilo de Calmette-Guerin, la radiografía torácica del año pasado es negativa y no presentan síntomas según la hoja de trabajo de tuberculosis.
    -Resultado positivo conocido en las pruebas del antígeno de superficie de la hepatitis B, del virus de la hepatitis C o del virus de la inmunodeficiencia humana.
    -AST/ALT elevadas >=1,5 veces por encima del límite superior de la normalidad durante la selección.
    -Aclaramiento de creatinina < 50 mL/min (según la fórmula de Cockroft-Gault, calculada por el laboratorio central).
    -Bilirrubina >=1,5 veces por encima del límite superior de la normalidad en la selección.
    -Anomalía analítica que, a criterio del investigador, impedirá que el sujeto termine el estudio o interferirá en la interpretación de sus resultados.
    -Mujer embarazada o en periodo de lactancia.
    -El sujeto no desea utilizar métodos anticonceptivos de alta eficacia durante el estudio, incluido el periodo de seguimiento de 2 semanas para las mujeres (excepto en el caso de mujeres con un mínimo de 2 años de menopausia o esterilizadas quirúrgicamente), y durante un máximo de 10 semanas tras la última dosis para los hombres (excepto los que cuya pareja sea menopáusica desde al menos 2 años o esté esterilizada quirúrgicamente).
    Los métodos anticonceptivos de alta eficacia son los que poseen un índice bajo de fallos si se utilizan correcta y coherentemente, como los implantes, inyectables, anticonceptivos orales combinados, algunos dispositivos intrauterinos (DIU), abstinencia sexual o vasectomía. Es responsabilidad del médico y el sujeto elegir conjuntamente un método anticonceptivo adecuado.
    -Actualmente el sujeto está participando o aún no han pasado como mínimo 30 días desde la finalización de su participación en otro/s estudio/s de un dispositivo o fármaco en investigación, o el sujeto está recibiendo otro/s fármaco/s en investigación.
    -Cualquier operación quirúrgica programada(como cirugía estética electiva) durante el estudio.
    -El sujeto no podrá acudir a las evaluaciones de seguimiento.
    -Presencia de cualquier trastorno que, a criterio del investigador, pueda comprometer la capacidad del sujeto para participar en el estudio, como p.ej. antecedentes de adicción a sustancias, alcoholismo o un cuadro psiq
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal de eficacia:
    Cambio en las puntuaciones del ACQ desde la situación basal hasta la 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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 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
    El final del estudio se define como la última visita del último sujeto del estudio.
    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 months2
    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 months2
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 375
    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 Decision2010-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-13
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