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    Summary
    EudraCT Number:2012-000656-34
    Sponsor's Protocol Code Number:20120103
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-07-19
    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 number2012-000656-34
    A.3Full title of the trial
    A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
    Estudio de fase 3 para evaluar la eficacia y la seguridad de las pautas de inducción y mantenimiento de brodalumab en comparación con placebo y ustekinumab en sujetos con psoriasis en placas de moderada a grave: AMAGINE-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test the Effect and Safety of Brodalumab Compared With Placebo and Ustekinumab and the Results of Changing Strength or Frequency of Brodalumab in People with Moderate to Severe Plaque Psoriasis: AMAGINE-2
    Estudio para evaluar la eficacia y la seguridad de Brodalumab en comparación con placebo y Ustekinumab y los resultados de cambiar la dosis y la frecuencia de brodalumab en personas con psoriasis en placas de moderada a grave: AMAGINE-2
    A.3.2Name or abbreviated title of the trial where available
    AMAGINE-2
    AMAGINE-2
    A.4.1Sponsor's protocol code number20120103
    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 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailMedinfoInternational@amgen.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 namebrodalumab (140 mg/ml)
    D.3.2Product code AMG 827
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 INNbrodalumab
    D.3.9.1CAS number 1174395-19-7
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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) 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 Stelara®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biotech
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 namebrodalumab (70 mg/0.5 ml)
    D.3.2Product code AMG 827
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 INNbrodalumab
    D.3.9.1CAS number 1174395-19-7
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe plaque psoriasis
    psoriasis en placas de moderada a grave
    E.1.1.1Medical condition in easily understood language
    moderate to severe plaque psoriasis
    psoriasis en placas de moderada a grave
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compared with placebo:
    -To evaluate the efficacy of brodalumab (210 mg every 2 weeks [Q2W]; and 140 mg Q2W) in
    subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects
    achieving 75% improvement in Psoriasis Area and Severity Index (PASI; PASI 75) at
    week 12
    -To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) in subjects with
    moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving
    success (clear [0] or almost clear [1]) on the static physician?s global assessment (sPGA) at
    week 12

    Compared with ustekinumab:
    -To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W for subjects
    <= 100 kg with 210 mg dosage for subjects > 100 kg) in clearing psoriasis in subjects with
    moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving
    PASI 100 at week 12
    En comparación con placebo:
    -Evaluar la eficacia de brodalumab (210 mg cada dos semanas [Q2W] y 140 mg Q2W) en
    sujetos con psoriasis en placas de moderada a grave, medida por la proporción de sujetos
    que consiguen una mejoría del 75% en el índice de intensidad y gravedad de la psoriasis
    (PASI, PASI 75) en la semana 12.
    - Evaluar la eficacia de brodalumab (210 mg Q2W y 140 mg Q2W) en sujetos con psoriasis en
    placas de moderada a grave, medida por la proporción de sujetos que consiguen un
    resultado satisfactorio (blanqueada [0] o casi blanqueada [1]) en la evaluación estática global
    realizada por el médico (sPGA) en la semana 12.

    En comparación con ustekinumab:
    -Evaluar la eficacia de brodalumab (210 mg Q2W y 140 mg Q2W en sujetos de <= 100 kg con
    una dosis de 210 mg en sujetos de > 100 kg) en el blanqueamiento de la psoriasis en sujetos
    con psoriasis en placas de moderada a grave, medida por la proporción de sujetos que
    alcanzan un PASI 100 en la semana 12.
    E.2.2Secondary objectives of the trial
    Placebo-family Objectives:
    - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W) compared with placebo: PASI 100 at week 12; sPGA of 0 at week 12; patient-reported symptoms of psoriasis at week 12.

    Compared with Ustekinumab
    - To evaluate the efficacy of brodalumab (140 mg Q2W): PASI 100 at week 12
    - To evaluate the efficacy of brodalumab (210 mg Q2W; and 140 mg Q2W for subjects <= 100 kg with 210 mg dosage for subjects > 100 kg): PASI 75 at week 12
    En comparación con placebo:
    -Evaluar la eficacia de brodalumab (210 mg Q2W y 140 mg Q2W) en comparación con placebo: PASI 100 en la semana 12; sPGA de 0 en la semana 12; síntomas de la psoriasis notificados por el paciente en la semana 12.

    En comparación con ustekinumab:
    - Evaluar la eficacia de brodalumab (140 mg Q2W): PASI 100 en la semana 12.
    - Evaluar la eficacia de brodalumab (210 mg Q2W y 140 mg Q2W en sujetos de <= 100 kg con
    una dosis de 210 mg en sujetos de > 100 kg); PASI 75 en la semana 12.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Brodalumab Pharmacokinetic Substudy Objective: To characterize the pharmacokinetics of brodalumab after short- and long-term treatment

    Biomarker development and pharmacogentic substudy:
    Objective: to collect samples for biomarker analysis; to investigate the effects of genetic variation in disease genes and drug target genes on psoriasis and/or subject response to brodalumab
    Objetivo del subestudio farmacocinético con Brodalumab: Caracterizar la farmacocinética de brodalumab tras el tratamiento a corto y a largo plazo.

    Subestudio del desarrollo de biomarcadores y farmacogenético:
    Objetivo: recoger muestras para análisis de biomarcadores; Investigar los efectos de la variación genética en los genes de la enfermedad y en los genes diana del fármaco sobre la psoriasis y/o la respuesta del sujeto a brodalumab
    E.3Principal inclusion criteria
    - Subject has provided informed consent.

    - Subject is >= 18 and <= 75 years of age at time of screening.

    - Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).

    - Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling.

    - Subject has involved body surface area (BSA) >= 10%, PASI >= 12, and sPGA >= 3 at screening and at baseline.
    -El sujeto ha dado su consentimiento informado.

    -El sujeto es >= de 18 y <= de 75 años en el momento de la selección.

    -El sujeto ha padecido psoriasis en placas estable de moderada a grave durante un mínimo de 6 meses antes de la primera dosis de PI (es decir, sin cambios morfológicos ni brotes significativos de actividad de la enfermedad en opinión del investigador).

    -El sujeto debe ser considerado, a criterio del investigador, como un candidato adecuado para el tratamiento con un agente biológico según la ficha técnica regional.

    - El sujeto tiene afectada >= 10% de la superficie corporal (BSA), un PASI >=12 y una sPGA >= 3 en el momento de la selección y a nivel basal.
    E.4Principal exclusion criteria
    - Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.

    - Subject has any concurrent medical condition that, in the opinion of the
    investigator, could cause this study to be detrimental to the subject.

    - Subject has used ustekinumab and/or anti-IL-17 biologic therapy ever or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.

    - Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).

    - Other investigational procedures are excluded.

    - Subject has known sensitivity to any of the products or components to be
    administered during dosing.

    - For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose (if discontinuing before week 52) or for 8 weeks after the last dose (if discontinuing at or after week 52).
    -El sujeto presenta cualquier enfermedad sistémica (p. ej., insuficiencia renal, insuficiencia cardíaca, hipertensión, enfermedad hepática, diabetes o anemia) que el investigador considere clínicamente significativa y no controlada.

    - El sujeto presenta cualquier enfermedad concurrente que, en opinión del investigador, podría hacer que este estudio sea perjudicial para el sujeto.

    -El sujeto ha utilizado alguna vez ustekinumab y/o un tratamiento biológico anti-IL-17 u otros inmunomoduladores biológicos disponibles experimental o comercialmente en las 12 semanas anteriores a la primera dosis del PI.

    - El sujeto está incluido actualmente en otro estudio de investigación de un fármaco o dispositivo, o han pasado menos de 30 días desde el fin de otro estudio de investigación de un fármaco o dispositivo, o recibe otro/s producto/s en investigación.

    -Se excluyen otros procedimientos de investigación.

    - El sujeto presenta una sensibilidad conocida a alguno de los productos o componentes que se administrarán durante la dosificación.

    -En el caso de mujeres: que están embarazadas o en período de lactancia, o que planeen quedarse embarazadas mientras participan en el estudio y durante las 15 semanas posteriores a la última dosis (si se interrumpe antes de la semana 52) o durante las 8 semanas posteriores a la última dosis (si se interrumpe en la semana 52 o más tarde).
    E.5 End points
    E.5.1Primary end point(s)
    Co-Primary: brodalumab arms vs placebo
    - PASI 75 at week 12
    - sPGA success at week 12

    Primary: brodalumab vs ustekinumab
    - PASI 100 at week 12
    - 210 mg Q2W
    - 140 mg Q2W for subjects <= 100 kg and 210 mg Q2W for subjects > 100 kg
    Covariables principales: grupos de brodalumab frente a placebo
    - PASI 75 en la semana 12.
    - sPGA satisfactoria en la semana 12.

    Principal: brodalumab frente a ustekinumab
    - PASI 100 en la semana 12.
    - 210 mg Q2W.
    - 140 mg Q2W en sujetos de <= 100 kg y 210 mg Q2W en sujetos de > 100 kg.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    Key Secondary: brodalumab arms vs placebo
    - PASI 100 at week 12
    - sPGA of 0 at week 12
    - Psoriasis Symptom Inventory responder definition at week 12

    Key Secondary: brodalumab vs ustekinumab
    - PASI 100 at week 12
    ? 140 mg Q2W
    - PASI 75 at week 12
    ? 210 mg Q2W
    ? 140 mg Q2W for subjects <= 100 kg and 210 mg Q2W for subjects > 100 kg

    For other secondary endpoints, please refer to section 10.1.1 in the protocol.
    Secundaria clave: grupos de brodalumab frente a placebo
    - PASI 100 en la semana 12.
    - sPGA 0 en la semana 12.
    - Respuesta en la semana 12 según la definición del inventario de síntomas de la psoriasis.

    Secundaria clave: brodalumab frente a ustekinumab
    - PASI 100 en la semana 12.
    - 140 mg Q2W.
    - PASI 75 en la semana 12.
    - 210 mg Q2W.
    - 140 mg Q2W en sujetos de <= 100 kg y 210 mg Q2W en sujetos de > 100 kg.

    Para otras variables secundarias, ver la sección 10.1.1 en el protocolo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Fase de inducción controlada double-ciega tras fase mantenimiento y fase de extensión a largo plazo
    double-blind controlled induction phase followed by maintenance phase and long-term extension phase
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Austria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Netherlands
    Poland
    Portugal
    Spain
    United Kingdom
    United States
    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
    "LVLS": The end of study is defined as when the last subject is assessed or receives an intervention for evaluation in the study (ie, the last subject has reached week 264 or
    ended the study).
    El fin del estudio se define como el momento en que el último sujeto se evalúa o recibe
    una intervención para la evaluación en el estudio (es decir, el último sujeto ha llegado a
    la semana 264 o ha finalizado el estudio).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 1710
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 577
    F.4.2.2In the whole clinical trial 1800
    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)
    Plans for treatment of care after the subject has ended participation are not different from the expected normal treatment for this condition.
    Después que el sujeto termine su participación en el ensayo clínico, los planes para su tratamiento o cuidados no son distintos de los tratamientos normales esperados en estas ocasiones.
    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 Decision2012-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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