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    Summary
    EudraCT Number:2011-004844-23
    Sponsor's Protocol Code Number:20101299
    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:2012-03-21
    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 number2011-004844-23
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 299)
    Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, para evaluar el efecto de AMG 747, como tratamiento adicional, sobre los síntomas negativos de la esquizofrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the effect of AMG 747 on schizophrenia negative symptoms (20101299)
    Estudio para evaluar el efecto de AMG 747 sobre los síntomas negativos de la esquizofrenia (20101299)
    A.3.2Name or abbreviated title of the trial where available
    Study 299
    A.4.1Sponsor's protocol code number20101299
    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 code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberNANANA
    B.5.5Fax numberNANANA
    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 nameAMG 747
    D.3.2Product code AMG 747
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeAMG 747
    D.3.9.3Other descriptive name(4-{(R)-phenyl[3-(trifluoromethyl)phenyl]methyl} piperazin-1-yl)acetic acid dimethanesulfonate
    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) 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 nameAMG 747
    D.3.2Product code AMG 747
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeAMG 747
    D.3.9.3Other descriptive name(4-{(R)-phenyl[3-(trifluoromethyl)phenyl]methyl} piperazin-1-yl)acetic acid dimethanesulfonate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP 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 747
    D.3.2Product code AMG 747
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeAMG 747
    D.3.9.3Other descriptive name(4-{(R)-phenyl[3-(trifluoromethyl)phenyl]methyl} piperazin-1-yl)acetic acid dimethanesulfonate
    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 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 placeboTablet
    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
    Schizophrenia
    Esquizofrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Esquizofrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the treatment effect of AMG 747 compared to placebo on negative symptoms as measured by the Negative Symptom Assessment Scale (NSA-16) in patients with schizophrenia stabilized with ongoing antipsychotic therapy
    Evaluar el efecto del tratamiento con AMG 747 en comparación con placebo sobre los síntomas negativos evaluados mediante la escala de evaluación de síntomas negativos (NSA-16) en pacientes con esquizofrenia estabilizada en tratamiento con antipsicóticos.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of AMG 747 on the proportion of subjects achieving clinically meaningful improvement from baseline, as defined by a => 20% decrease from baseline on negative symptoms as measured by the NSA-16;
    - To evaluate the effect of AMG 747 on symptoms of schizophrenia as measured by the PANSS total score and Marder factor scores;
    - To evaluate the effect of AMG 747 on global change as measured by the CGI-S and CGI-I scales;
    - To evaluate the effect of AMG 747 on cognitive function as measured by the MATRICS Consensus Cognitive Battery (MCCB);
    - To evaluate the effect of AMG 747 on everyday functioning as measured by the PSP scale;
    - To evaluate the effect of AMG 747 on PROs as measured by the Q-LES-Q-18 and SDS;
    - To evaluate safety and tolerability of AMG 747.
    Evaluar el efecto de AMG 747: Sobre la proporción de sujetos que consiguen una mejoría clínicamente significativa en comparación con el nivel basal, definida como una disminución => 20% desde el nivel basal de los síntomas negativos, mediante la NSA-16.Sobre los síntomas de la esquizofrenia, mediante la puntuación total de la escala de los síndromes positivo y negativo (PANSS) y las puntuaciones de los factores de Marder.Sobre el cambio global, mediante las escalas de impresión clínica global de gravedad (CGI-S) y de impresión clínica global de mejoría (CGI-I).Sobre la función cognitiva, mediante la batería cognitiva de consenso MATRICS (MCCB).Sobre el desempeño cotidiano, mediante la escala de funcionamiento personal y social (PSP).Sobre los resultados notificados por los pacientes (PRO), mediante el cuestionario sobre calidad de vida: satisfacción y placer (Q-LES-Q-18) y la escala de discapacidad de Sheehan (SDS).La seguridad y la tolerabilidad de AMG 747.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Pharmacokinetic (PK) sub-study, 21 October 2011: This sub-study will be carried out on a subset of approximately 90 subjects (approximately 20 subjects per AMG 747 treatment group) at selected sites. These subjects will be required to sign an additional optional informed consent to participate in this sub-study. The PK sub-study enrollment will be blinded; however, the PK samples will be analyzed only for those subjects assigned to an AMG 747 treatment group. PK sub-study enrollment will close once the target number of PK sub-study participants has been reached. PK sub-study subjects will have additional blood samples collected at 1.5, 4 and 24 hours post-dose at baseline/day 1 (ie, after first IMP dose) and at 0.5 and 2 hours post-dose at week 4. The purpose of this sub-study is to evaluate the pharmacokinetic profile of AMG 747 when given as a daily oral dose in subjects with schizophrenia stabilized with ongoing antipsychotic therapy.

    - Pharmacogenetic sub-study, 21 October 2011: If a subject signs the additional optional informed consent (Pharmacogenetic Consent), DNA extracted from the cell pellets from pre-dose PK plasma samples on baseline/day 1, week 4 and week 8 may be analyzed for optional, exploratory pharmacogenetic analyses.
    These optional analyses focus on inherited genetic variations, to evaluate their possible correlation to the disease and/or responsiveness to the therapies used in this study. The goals of these optional studies include the use of genetic markers to help in the investigation of neuropsychiatric disorders such as schizophrenia and/or to identify subjects who may respond positively or negatively to AMG 747.
    - Subestudio farmacocinético (PK), 21 Octubre 2011: Se llevará a cabo en un subgrupo de 90 sujetos de algunos centros. La participación será opcional y los sujetos que accedan deberán firmar un consentimiento informado específico. Se tomarán muestras 1.5, 4 y 24 h post-dosis en la visita basal y a las 0.5 y 2 horas post-dosis en la semana 4 para evaluar el perfil PK de AMG 747.
    - Subestudio farmacogenético, 21 October 2011: Para participar en este subestudio opcional, los pacientes deberán firmar un consentimiento informado específico. Se analizará el DNA del sedimento celular de las muestras de plasma extraídas en las visitas basal y semanas 4 y 8. Los análisis se centrarán en las variaciones genéticas hereditarias para valorar su posible correlación con la enfermedad y la respuesta al tratamiento del estudio. El propósito del subestudio incluye la utilización de marcadores genéticos que ayuden en la investigación de la patología y en la identificación de sujetos que puedan responder positivamente a AMG 747.
    E.3Principal inclusion criteria
    - Adults, 18-60 years of age upon entry into screening;
    - Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia;
    - Total score on the PANSS Marder Negative Symptom Factor Scale (NSFS) => 20, Total score on the PANSS Marder Positive Symptom Factor
    Scale (PSFS) ? 30;
    - Receiving stable antipsychotic therapy for at least 8 weeks prior to screening;
    - Receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening;
    - Subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study;
    - Subject or subject's legally acceptable representative has provided informed consent.
    -Adultos de 18 a 60 años de edad en el momento de la selección.
    -Diagnóstico de esquizofrenia del Manual diagnóstico y estadístico de los trastornos mentales, cuarta edición, revisión del texto (DSM-IV-TR).
    - Puntuación total de la escala de factores de síntomas negativos de Marder (NSFS) de la PANSS => 20, con una puntuación de => 4 en el menos 2 de los siguientes elementos de la PANSS: N1, N2, N3, N4 y N6;
    - puntuación total en la escala de factores de síntomas positivos de Marder (PSFS) de la PANSS <= 30, con una puntuación de <= 4 en cada elemento de la PSFS, excepto por una puntuación de 5 en no más de 1 elemento; y
    -puntuación del elemento P2 de la PANSS <= 4.
    -Recibir tratamiento antipsicótico estable (para este estudio, estabilidad se define como sin nueva medicación, sin aumento y con una disminución <= 25% en cualquier dosis del antipsicótico) durante al menos 8 semanas antes de la selección.
    -Recibir una dosis estable de otros agentes psicotrópicos (definida como una disminución <= 25% de la dosis del psicotrópico) durante al menos 8 semanas antes de la selección
    -El sujeto ha tenido una residencia o un domicilio estable durante al menos 8 semanas antes de la selección y no está previsto que la residencia o el domicilio cambien mientras dure el estudio.
    -El sujeto o su representante legal autorizado ha proporcionado el consentimiento informado.
    E.4Principal exclusion criteria
    - Current schizoaffective or bipolar disorder, panic disorder, obsessive
    compulsive disorder, evidence of mental retardation by history or clinical
    examination or known premorbid IQ ? 70;
    - Clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam;
    - Substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening;
    - Substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening or during screening;
    - Planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study;
    - Positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines).
    Trastorno bipolar o esquizoafectivo en curso, trastorno de pánico, trastorno obsesivo-compulsivo, evidencia de retraso mental según la historia clínica o la exploración clínica o CI premórbido conocido <=70.
    Pensamientos suicidas clínicamente significativos o intentos de suicidio, comportamiento agresivo o cambios marcados de humor en las 8 semanas previas a la selección, o confirmación actual de pensamientos suicidas durante la exploración clínica
    Abuso de sustancias (excepto el abuso de nicotina o cafeína) en las 8 semanas previas a la selección, o durante la selección.
    Dependencia de sustancias (excepto la dependencia de nicotina o cafeína) en los 6 meses previos a la selección, o durante la selección.
    Tener previsto empezar un tratamiento para dejar de fumar o modificar de forma sustancial el uso de la nicotina durante el estudio.
    Prueba positiva de sustancias de abuso en la orina (a excepción de resultados positivos para agentes prescritos, como las benzodiacepinas).
    Para el resto de criterios de exclusión ver el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 12 in negative symptoms, as measured by the NSA-16 total score
    Cambio en los síntomas negativos, evaluados mediante la puntuación total de la NSA-16, desde el nivel basal hasta la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Semana 12
    E.5.2Secondary end point(s)
    - Response defined as a => 20% decrease in the NSA-16 total score at week 12;
    - Change from baseline to week 12 on the PANSS total score and Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression symptoms);
    - Change from baseline to week 12 on the CGI-S;
    - CGI-I scores at week 12;
    - Change from baseline to week 12 on the MCCB;
    - Change from baseline to week 12 on the PSP;
    - Change from baseline to week 12 on the Q-LES-Q-18 and SDS;
    Safety Endpoints:
    - Adverse events;
    - Clinical laboratory values and vital signs;
    - 12-lead ECG;
    - Calgary Depression Scale for Schizophrenia (CDSS), Columbia-Suicide Severity Rating Scale (C-SSRS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS).
    -Respuesta definida como una disminución => 20% en la puntuación total de la NSA-16 en la semana 12.
    Cambio en la puntuación total de la PANSS y en las puntuaciones de los factores de Marder (síntomas positivos, negativos, de pensamiento desorganizado, de hostilidad/nerviosismo o de ansiedad/depresión) desde el nivel basal hasta la semana 12.
    Cambio en la CGI-S desde el nivel basal hasta la semana 12.
    Puntuaciones de la CGI-I en la semana 12.
    Cambio desde el nivel basal hasta la semana 12 en la MCCB.
    Cambio en la PSP desde el nivel basal hasta la semana 12.
    Cambio en el Q-LES-Q-18 y la SDS desde el nivel basal hasta la semana 12.
    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) 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 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 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
    European Union
    Australia
    Canada
    New Zealand
    Singapore
    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
    The time when the last subject completes the last study visit
    El momento en el que el último sujeto completa la última visita 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 months11
    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 months11
    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: 270
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 270
    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)
    Standard of care treatment for the condition
    Tratamiento habitual de la enfermedad
    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 Decision2012-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-14
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