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    Summary
    EudraCT Number:2011-005217-37
    Sponsor's Protocol Code Number:I4O-MC-BACC(a)
    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:2012-08-09
    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 number2011-005217-37
    A.3Full title of the trial
    Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer?s Disease or Mild Alzheimer's Disease
    Evaluación de la seguridad, la tolerabilidad y los efectos farmacodinámicos de LY2886721 en pacientes con deterioro cognitivo leve debido a enfermedad de Alzheimer o enfermedad de Alzheimer leve
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
    A.4.1Sponsor's protocol code numberI4O-MC-BACC(a)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01561430
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressClinical Trial Information
    B.5.3.2Town/ cityClinical Trial Information
    B.5.3.3Post codeClinical Trial
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameLY2886721
    D.3.2Product code LY2886721
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1262036-50-9
    D.3.9.2Current sponsor codeLY2886721
    D.3.9.3Other descriptive nameLY2886721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 nameFlorbetapir (18F)
    D.3.2Product code Florbetapir (18F)
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFlorbetapir (18F)
    D.3.9.1CAS number 956103-76-7
    D.3.9.2Current sponsor codeflorbetapir F 18, AMYViD
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number720 to 2090
    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 Yes
    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 nameLY2886721
    D.3.2Product code LY2886721
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1262036-50-9
    D.3.9.2Current sponsor codeLY2886721
    D.3.9.3Other descriptive nameLY2886721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Mild Cognitive Impairment Due to Alzheimer?s Disease or Mild Alzheimer's Disease
    Deterioro cognitivo leve debido a enfermedad de Alzheimer o enfermedad de Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease
    Enfermedad de Alzheimer
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the CSF PD effect of different LY2886721 doses in patients with MCI due to AD or mild AD compared to placebo, measured by change of CSF
    A?1-40 and A?1-42 concentrations from baseline to Week 12 and Week 26.
    El objetivo principal de este estudio es evaluar el efecto FD en el LCR de dosis diferentes de LY2886721 en pacientes con DCL debido a EA o EA leve en comparación con el placebo, medido por la variación de las concentraciones de Aβ1-40 y Aβ1-42 en el LCR desde el inicio del estudio a las semanas 12 y 26.
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of LY2886721 over 26 weeks
    To compare cerebral vasogenic edema (CVE) and cerebral microhemorrhage (CMH) using fluid attenuation inversion recovery (FLAIR) and T2*w magnetic resonance imaging (MRI) associated with different doses of LY2886721 treatment or placebo
    To assess the plasma PD effect of different LY2886721 doses compared to placebo, measured by change of plasma A?1-40 and A?1-42 concentrations from baseline to Week 12 and 26.
    To assess the effect of 2 doses of LY2886721 compared to placebo on the cognitive and behavioral symptoms of AD measured by Neuropsychological Test Battery (NTB), Alzheimer?s Disease Assessment Scale ? Cognitive subscale (ADAS-Cog), Mini Mental State Examination (MMSE), and Neuropsychiatric Inventory (NPI).
    To assess the effect of 2 doses of LY2886721 compared to placebo on the global rating of symptoms of AD measured by the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB).
    -Evaluar seguridad y tolerabilidad de LY2886721 durante 26 semanas.
    -Comparar edema vasógeno cerebral (EVC) y microhemorragias cerebrales (MHC) mediante resonancia magnética (RM) con recuperación de inversión atenuada por líquido (FLAIR) y T2*w asociados al tto. con diferentes dosis de LY2886721 o placebo.
    -Evaluar el efecto FD en plasma de diferentes dosis de LY2886721 en comparación con placebo, medido por la variación de las concentraciones plasmáticas de Aβ1-40 y Aβ1-42 desde el inicio del estudio a las semanas 12 y 26.
    -Evaluar efecto de 2 dosis de LY2886721 en comparación con placebo en los síntomas cognitivos y conductuales de la EA mediante la NTB, la ADAS-Cog, el MMSE y el NPI.
    -Evaluar efecto de 2 dosis de LY2886721 en comparación placebo en la evaluación global de los síntomas de la EA, medido mediante la suma de las casillas de la CDR-SB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Present with MCI due to AD or mild AD based on the disease diagnostic criteria
    [2] Are men or postmenopausal women, at least 55 years of age.
    Postmenopausal women are defined as women who have had a
    hysterectomy and/or bilateral oophorectomy; or who have been
    amenorrheic for at least 2 years.
    [3] Have a reliable caregiver/study informant who provides a separate written informed consent to participate and who is in frequent contact with the patient (defined as at least 10 hours per week). The caregiver/study informant must be able to communicate with site personnel and in the investigator?s opinion must have adequate literacy to complete the protocol-specified questionnaires. If a caregiver/study informant cannot
    continue, 1 replacement is allowed.
    [4] Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
    [5] Have adequate premorbid literacy in the investigator?s opinion to complete the required psychometric tests
    [6] Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

    Disease Diagnostic Criteria
    Patients with MCI due to AD or mild AD will be selected according to the following criteria:
    - Gradual and progressive change in memory function reported by patient or caregiver/study informant over more than 6 months.
    - Objective evidence of significantly impaired episodic memory characteristic of hippocampal dysfunction on testing: Free and Cued Selective Reminding Test with Immediate Recall (FCSRT ? IR): ?16 for free recall or ?40 for total recall. The episodic memory impairment can be isolated or associated with other cognitive changes at the onset of AD or as AD advances.
    - Clinical Dementia Rating Scale (CDR) = 0.5 or 1, memory box score ?0.5
    - Mini Mental State Examination (MMSE) 20 to 30
    - florbetapir F18 scan positive for the presence of A?(based on central review)
    [1] Presencia de DCL debido a EA o EA leve según los criterios diagnósticos de la enfermedad (sección 8.1.1).
    [2] Varones o mujeres posmenopáusicas de al menos 55 años de edad. Las mujeres posmenopáusicas se definen como aquellas que se hayan sometido a una histerectomía y/u ovariectomía bilateral, o que hayan tenido amenorrea durante al menos 2 años.
    [3] Disponer de un cuidador/informador del estudio fiable que otorgue su consentimiento informado por escrito independiente para participar y que esté en contacto frecuente con el paciente (definido como al menos 10 horas a la semana). El cuidador/informador del estudio debe ser capaz de comunicarse con el personal del centro y, en opinión del investigador, debe tener un grado de alfabetización suficiente para cumplimentar los cuestionarios especificados del protocolo. Si un cuidador/informador del estudio no puede continuar, se permite una única sustitución.
    [4] Tener, en opinión del investigador, una visión (no cumplir el criterio de exclusión 12) y audición suficientes para las pruebas neuropsicológicas.
    [5] Tener, en opinión del investigador, un grado de alfabetización premórbido suficiente para realizar las pruebas psicométricas exigidas.
    [6] Otorgar el consentimiento informado por escrito aprobado por Lilly y el comité ético de investigación clínica (CEIC) del centro.

    Criterios diagnósticos de la enfermedad:
    Se seleccionará a pacientes con DCL debido a EA o EA leve según los criterios siguientes:
    • Alteración gradual y progresiva de la función de la memoria referida por el paciente o el cuidador/informador del estudio durante más de 6 meses.
    • Signos objetivos de deterioro significativo de la memoria episódica, característicos de disfunción del hipocampo en las pruebas: prueba de recuerdo selectivo libre y facilitado con recuerdo inmediato (FCSRT-IR): ≤ 16 para el recuerdo libre o ≤ 40 para el recuerdo total. El deterioro de la memoria episódica puede ser aislado o asociarse a otras alteraciones cognitivas al inicio de la EA o conforme progresa la EA.
    • Escala de valoración clínica de la demencia (CDR) = 0,5 o 1, puntuación de la casilla de la memoria ≥ 0,5.
    • Puntuación en el miniexamen cognoscitivo (MMSE) de 20 a 30.
    • Estudio con florbetapir F-18 positivo para la presencia de Aβ (basado en la revisión central).
    E.4Principal exclusion criteria
    ?Participant in another drug or device study
    ?Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease or Parkinson's disease, progressive supranuclear palsy (PSNP) or other movement disorder
    ?Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than two months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed
    ?Have had a serious infectious disease affecting the brain in the past 5 years
    ?Have had a serious or repeat head injury
    ?Have significant retinal impairment or disease
    ?Have had a stroke or other circulation problems that are affecting your current health
    ?Have had a positron emission tomography (PET) scan in the past 6 months
    ?Have had a seizure
    ?Have major depressive disorder (participation is allowed if depressive symptoms are treated with stabile administration of antidepressants) or another mental illness such as schizophrenia or bipolar disorder
    ?History of alcohol or drug abuse
    ?Have asthma, chronic obstructive pulmonary disease (COPD) or other breathing disease that is not controlled with medicine
    ?Have human immunodeficiency virus (HIV) or syphilis
    ?Have any medical condition requiring double and triple anti-platelet treatment (for example, combination of aspirin with Clopidogrel, and/or Cilostazol). Note: single antiplatelet therapy is not an exclusion criteria.
    - Participar en otro estudio de Fármaco o dispositivo
    - Hoitoria de Demencia frontotemporal, enfermedad con cuerpos de Lewy, demencia vascular, enfermedad de Huntington o enfermedad de Parkinson concomitante, parálisis supranuclear progresiva (PSNP) u otro trastorno del movimiento
    -Pacientes no estables al tratamiento habitual (inhibidores de la acetilcolinesterasa, memantina) iniciado al menos 2 meses antes de entrar en el estudio o al menos 4 semanas de terapia estable. Nota: Está permitido el tratamiento standard estable
    - Antecedentes en los últimos 5 años de enfermedad infecciosa grave que afecte al encéfalo
    -Traumatismo craneoencefálico grave o recurrente
    -Disfunción o enfermedad importante de la retina
    - Haber padecido Ictus u otros problemas circulatorios que afecten a la salud actual del paciente
    -Haberse realizado una PET en los últimos 6 meses
    -Antecedentes de crisis convulsiva
    -Depresión mayor (podrán participar pacientes en tratamiento estable con antidepresivos o ansiolíticos) u otra enfermedad mental como esquizofrenia o trastorno bipolar
    - Antecedentes de alcoholismo o drogadicción
    - Antecedentes de asma , enfermedad pulmonar obstructiva crónica inestable u otras enfermedades respiratorias no controladas con Fármacos. (Nota: podrán participar pacientes con enfermedad estable.)
    - Virus de la inmunodeficiencia humana o sífilis
    - Cualquier enfermedad que requiera tratamiento antiagregante plaquetario doble y triple (por ejemplo, combinación de ácido acetilsalicílico con clopidogrel o cilostazol). Nota: el tratamiento antiagregante plaquetario simple no es un criterio de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    ?Change from baseline to 12 weeks in cerebrospinal fluid (CSF) amyloid beta (A?)1-40 and A?1-42 concentrations [Time Frame: Baseline, 12 weeks]
    ?Change from baseline to 26 weeks in cerebrospinal fluid (CSF) amyloid beta (A?)1-40 and A?1-42 concentrations [Time Frame: Baseline, 26 weeks]
    - Cambios en la concentración de beta amiloide (Aβ)1-40 y Aβ1-42 en el líquido cefalorraquideo (LCR) (Marco de tiempo: basal, 12 semanas)
    - Cambios en la concentración de beta amiloide (Aβ)1-40 y Aβ1-42 en el líquido cefalorraquideo (LCR) (Marco de tiempo: basal, 26 semanas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ?Change from baseline to 12 weeks in cerebrospinal fluid (CSF) amyloid beta (A?)1-40 and A?1-42 concentrations [Time Frame: Baseline, 12 weeks]
    ?Change from baseline to 26 weeks in cerebrospinal fluid (CSF) amyloid beta (A?)1-40 and A?1-42 concentrations [Time Frame: Baseline, 26 weeks]
    - Cambios de la basal a la Semana 12 en la concentración de beta amiloide (Aβ)1-40 y Aβ1-42 en el líquido cefalorraquideo (LCR) (Marco de tiempo: basal, 12 semanas)
    -Cambios de la basal a la Semana 26 en la concentración de beta amiloide (Aβ)1-40 y Aβ1-42 en el líquido cefalorraquideo (LCR) (Marco de tiempo: basal, 26 semanas)
    E.5.2Secondary end point(s)
    ?Change from baseline in plasma amyloid beta (A?)1-40 and A?1-42 concentrations
    ?Change from baseline to 26 weeks in Neuropsychological Test Battery (NTB)
    ?Change from baseline to 26 weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
    ?Change from baseline to 26 weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
    ?Change from baseline to 26 weeks in Mini Mental State Examination (MMSE)
    -Cambios en la concentración de beta amiloide (Aβ)1-40 y Aβ1-42 en el plasma desde la basal
    -Cambios en la Batería de pruebas Neuropsicológicas desde la basal a la Semana 26.
    -Cambios en la escala de evaluación de la enfermedad de Alzheimer (ADAS-Cog)desde la basal a la Semana 26.
    -Cambios en la escala de valoración clínica de la demencia (CDR-SB) desde la basal a la Semana 26.
    -Cambios en el miniexamen cognoscitivo (MMSE) desde la basal a la Semana 26.



    E.5.2.1Timepoint(s) of evaluation of this end point
    ?Change from baseline in plasma amyloid beta (A?)1-40 and A?1-42 concentrations [Time Frame: Baseline, 12 weeks, 26 weeks ]
    ?Change from baseline to 26 weeks in NTB [Time Frame: Baseline, 26 weeks]
    ?Change from baseline to 26 weeks in ADAS-Cog [Time Frame: Baseline, 26 weeks ]
    ?Change from baseline to 26 weeks in the CDR-SB [ Time Frame: Baseline, 26 weeks ]
    ?Change from baseline to 26 weeks in MMSE [Time Frame: Baseline, 26 weeks ]
    -Cambios en la concentración de beta amiloide (Aβ)1-40 y Aβ1-42 en el plasma desde la basal (Marco de tiempo: Basal, Semana 12 y Semana 26)
    -Cambios en la Batería de pruebas Neuropsicológicas desde la basal a la Semana 26.(Marco de tiempo: Basal, Semana 26)

    -Cambios en la escala de evaluación de la enfermedad de Alzheimer (ADAS-Cog)desde la basal a la Semana 26.(Marco de tiempo: Basal, Semana 26)

    -Cambios en la escala de valoración clínica de la demencia (CDR-SB) desde la basal a la Semana 26.(Marco de tiempo: Basal, Semana 26)

    -Cambios en el miniexamen cognoscitivo (MMSE) desde la basal a la Semana 26.(Marco de tiempo: Basal, Semana 26)




    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 Yes
    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) 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Italy
    Japan
    Netherlands
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last visit
    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 months9
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 260
    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)
    As per protocol
    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 Decision2012-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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