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    Summary
    EudraCT Number:2012-003313-34
    Sponsor's Protocol Code Number:SPD489-345
    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:2013-03-06
    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 number2012-003313-34
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, 12-month Extension Safety and Tolerability Study of SPD489 in the Treatment of Adults with Binge Eating Disorder
    Estudio de extensión de fase III, multicéntrico, abierto, de 12 meses de duración para evaluar la seguridad y tolerabilidad de SPD489 en adultos con trastorno por atracón
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder
    Estudio para evaluar el fármaco del ensayo, SPD489, en sujetos adultos con trastorno por atracón.
    A.3.2Name or abbreviated title of the trial where available
    SPD489-345
    A.4.1Sponsor's protocol code numberSPD489-345
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01657019
    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 SponsorShire Development LLC
    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 supportShire Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceutical Ltd
    B.5.2Functional name of contact pointMedical Communications
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityChineham, Basingstoke
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448000556614
    B.5.5Fax number+441256894714
    B.5.6E-mailmedinfoglobal@shire.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 Yes
    D.2.1.1.1Trade name Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    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.3.1Product nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    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.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 Yes
    D.2.1.1.1Trade name Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    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.3.1Product nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 Yes
    D.2.1.1.1Trade name Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    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.3.1Product nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-32-2
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameLISDEXAMFETAMINE DIMESYLATE
    D.3.9.4EV Substance CodeSUB32146
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. Though currently listed in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) appendix as a disorder provided for further study, it has been recommended that BED be formally included as an eating disorder in DSM-V.
    El trastorno por atracón se caracteriza por episodios recurrentes y angustiosos de consumo incontrolado de grandes cantidades de alimentos (atracón), sin ir acompañados por la conducta compensatoria para perder peso asociada a la bulimia nerviosa. Aunque actualmente se incluye en el anexo del manual DSM-IV como un trastorno propuesto para estudios posteriores, se ha recomendado que el TPA se incluya formalmente como un trastorno alimentario en el manual DSM-V.
    E.1.1.1Medical condition in easily understood language
    Binge eating disorder
    Trastorno por atracón
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    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 long-term safety and tolerability of SPD489 (50 and 70mg/day) for the treatment of BED in adults 18-55 years of age (inclusive at the time of consent for the respective antecedent SPD489 BED trial). Long-term safety will be described using:
    1. Occurrence of TEAEs.
    2. Response to the Columbia Suicide Severity Rating Scale (C-SSRS).
    3. Specific evaluation of blood pressure and pulse, weight and waist circumference, clinical laboratory evaluations, and ECG results.
    Evaluar la seguridad y tolerabilidad a largo plazo de SPD489 (50 y 70 mg/día) para el tratamiento del TPA en adultos (de entre 18 y 55 años, inclusive, en el momento del consentimiento del anterior estudio sobre el TPA con SPD489). La seguridad a largo plazo se describirá mediante:
    1. Aparición de acontecimientos adversos aparecidos durante el tratamiento (AAT).
    2. Escala de valoración de gravedad de la conducta suicida de la Universidad de Columbia (C-SSRS)
    3. Evaluación específica de la presión arterial y el pulso, el peso y el perímetro de cintura, las evaluaciones de las analíticas clínicas y los resultados del electrocardiograma (ECG).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effect of SPD489 on the following clinical experience outcomes (including efficacy and quality of life [QoL]):
    1. The global impressions of BED improvement as measured by the Clinical Global Impressions of Improvement (CGI-I) scale.
    2. The response in binge eating behavior as measured by Eating Disorder Questionnaire (EDE-Q).
    3. QoL as measured by the EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L).
    Exploratory Objectives:
    1. To explore the utilization of healthcare resources in subjects with moderate to severe BED using the Patient Resource Utilization Questionnaire for Binge Eating Disorder (PRUQ BED).
    2. To explore the role of additional parameters of interest in the treatment of BED. Potential parameters that may be studied include, but are not limited to, C-reactive protein (CRP), leptin, and ghrelin.
    Los objetivos secundarios son evaluar el efecto de SPD489 en los siguientes criterios de valoración de la experiencia clínica (incluidas la eficacia y la calidad de vida [CdV]):
    1. Impresión de global de la mejoría del TPA, evaluada mediante la Escala de impresión clínica global de la mejoría (CGI-I).
    2. La respuesta a la conducta de atracón, evaluada mediante el Cuestionario examen de trastornos de la conducta alimentaria (EDE-Q).
    3. CdV según el Cuestionario autoadministrado de 5 niveles y 5 dimensiones del grupo EuroQoL (EQ-5D-5L).
    Objetivos exploratorios:
    1. Estudiar el uso de los recursos sanitarios en pacientes con TPA moderado o grave, utilizando el Cuestionario de utilización de recursos de pacientes para el trastorno por atracón (PRUQ-BED).
    2. Estudiar el papel de parámetros de interés adicionales en el tratamiento del TPA. Los posibles parámetros que pueden estudiarse pueden ser, entre otros, la proteína C-reactiva (PCR), la leptina y la grelina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject cannot be enrolled in the study before all inclusion criteria (including test results) are confirmed.

    All subjects must meet the following criteria:

    1.-Subject has completed 1 of the respective antecedent SPD489 BED trials.
    2.- Subject is between 18-55 years of age (or age of majority if greater than 18 years of age, as defined by local regulations), inclusive, at the time of consent from the antecedent trial.
    3.- Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
    4.- Subject has a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by physical examination findings, clinical laboratory test results, ECG results, or vital sign results that would preclude treatment with SPD489.
    5.- Subject has an understanding, ability, and willingness to fully comply with study related procedures and restrictions.
    No se podrá incluir a un paciente en el estudio hasta que no se cumplan todos los criterios de inclusión (incluyendo los resultados de las pruebas): Todos los pacientes deben cumplir los siguientes criterios:
    1.- Pacientes que hayan completado uno de los estudios anteriores sobre TPA con SPD489.
    2.- Pacientes que tengan entre 18 (o, si las leyes locales fijan la mayoría de edad en una edad superior, la edad a la que se alcance la mayoría) y 55 años de edad, ambos inclusive, en el momento del consentimiento del estudio anterior.
    3.- Pacientes capaces de otorgar por escrito, firmar personalmente y fechar el consentimiento informado para participar en el estudio antes de realizar cualquier procedimiento relacionado con el estudio.
    4.- Pacientes con una evaluación médica satisfactoria sin anomalías clínicamente significativas o importantes, según los resultados de la exploración física, los análisis clínicos, el ECG o las constantes vitales que impidan el tratamiento con SPD489.
    5.- Pacientes que comprendan, puedan y deseen cumplir todos los procedimientos y restricciones relacionados con el estudio.
    E.4Principal exclusion criteria
    Subjects that have a gap in participation of 30 days or more from completion of the antecedent study Follow-up Visit are excluded from the study if any of the following criteria are met:

    1.- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa, confirmed by SCID-I Module H.
    2.- Subject has a current comorbid Axis I or Axis II psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms (note: subjects with mild mood or anxiety symptoms that do not meet criteria for Axis I disorder, do not require treatment based on the Investigator's assessment, and do not confound efficacy or safety assessments in the opinion of the examining Investigator may be included).
    3.- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
    4.- Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
    5.- Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder in accordance with Diagnostic Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. Nicotine dependence is not exclusionary.
    6.- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
    7.- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
    8.- Subjects with a history of moderate to severe hypertension or an average (of 3 readings) resting systolic blood pressure >139mmHg or an average (of 3 readings) diastolic blood pressure >89mmHg at study entry. Note: subjects with mild (Stage 1), well-controlled hypertension on a stable antihypertensive treatment regimen, defined as having maintained the current dose for a period of at least 3 months or more at the time of the Screening Visit (Visit -1) are allowed.
    9.- Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious disease process requiring antibiotics or diabetes), disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Subject will be excluded if he or she has any additional condition(s) that in the Investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the subject to participate in the study. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary.
    Se excluyen a los pacientes que hayan tenido un lapso de participación de 30 días o más en el estudio previo a este de seguimiento y si cumple alguno de los siguientes criterios

    1.- El paciente tiene síntomas concomitantes de bulimia nerviosa o anorexia nerviosa, según lo definido en el módulo H de la SCID-I.
    2.- Pacientes que padecen un trastorno psiquiátrico asociado del Eje I o del Eje II que está controlado con medicamentos prohibidos en este estudio o no está controlado y se asocia a síntomas significativos (nota: se puede incluir a pacientes con síntomas de trastorno del estado de ánimo o ansiedad leves que no cumplan los criterios para trastornos del Eje I, que no requieran tratamiento según la evaluación del investigador y que no interfieran en las evaluaciones de la eficacia o la seguridad según la opinión del investigador).
    3.- Pacientes con antecedentes de psicosis, manía, hipomanía, demencia o trastorno de déficit de atención/hiperactividad.
    4.- Pacientes con riesgo de suicidio, en opinión del investigador, que hayan realizado previamente un intento de suicidio o que demuestren ideas suicidas activas. No es necesario excluir a los pacientes con ideas suicidas intermitentes según la evaluación del investigador.
    5.- Pacientes con antecedentes recientes (en los últimos 6 meses) de sospecha de abuso de sustancias o trastorno de dependencia, según los criterios del Manual diagnóstico y estadístico de los trastornos mentales, 4.ª edición, texto revisado. Se excluirá a los pacientes con antecedentes de abuso y/o dependencia de anfetaminas, cocaína u otros estimulantes. La dependencia de la nicotina no se considera motivo de exclusión
    6.- Pacientes con antecedentes conocidos de enfermedad cardiovascular sintomática, arterioesclerosis avanzada, anomalías cardíacas estructurales, miocardiopatía, anomalías graves del ritmo cardíaco, arteriopatía coronaria u otros problemas cardíacos graves que puedan hacer que se aumente la vulnerabilidad a los efectos simpaticomiméticos de un medicamento estimulante.
    7.- Pacientes con antecedentes familiares conocidos de muerte súbita cardíaca o arritmia ventricular.
    8.- Pacientes con antecedentes de hipertensión moderada o grave o que tengan una presión arterial sistólica media en sedestación y en descanso (3 lecturas) > 139 mmHg o una presión arterial diastólica media (3 lecturas) > 89 mmHg en la visita de admisión (visita 0). Nota: se permite la inclusión de pacientes con hipertensión leve (nivel 1) bien controlada con una tratamiento antihipertensor estable, definido como el mantenimiento de la dosis actual durante un periodo de al menos 3 meses o más en el momento de la visita de selección (visita -1).
    9.- Pacientes con una enfermedad concurrente aguda o crónica (como rinitis alérgica intensa, un proceso infeccioso que requiera antibióticos o diabetes), discapacidad u otras enfermedades que pudieran interferir en los resultados de las evaluaciones de seguridad realizadas en el estudio o que pudieran aumentar el riesgo del paciente. Se excluirá a los pacientes que padezcan alguna otra enfermedad que, en opinión del investigador, impediría al paciente completar el estudio o que haría que la participación en el estudio no fuera lo mejor para el paciente. Esto incluiría, cualquier enfermedad significativa o trastorno médico inestable que pudiera dificultar el cumplimiento del protocolo. El asma leve y estable no se considera un motivo de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    - The number and percentage of TEAEs
    - Response to the C-SSRS
    - Specific evaluation of blood pressure and pulse, weight and waist circumference, BMI, clinical laboratory evaluations, and ECG results.
    - Número y porcentaje de AAT.
    - Respuesta a la escala C-SSRS
    - Evaluación específica de la presión arterial y el pulso, el peso y el perímetro de cintura, el IMC, las evaluaciones de las analíticas clínicas y los resultados del ECG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - TEAEs, C-SSRS, BP/Pulse, Weight: Visits Scr/0-17
    - Waist Circumference: Visits Scr/0, 4, 8, 12, 16/ET
    - BMI: Visits Scr/0
    - Labs: Scr/0, 6, 9, 16/ET
    - ECG: Scr/0-4, 8, 12, 16/ET-17
    - TEAEs, C-SSRS, BP/Pulse, Weight: Visits Scr/0-17
    - Waist Circumference: Visits Scr/0, 4, 8, 12, 16/ET
    - BMI: Visits Scr/0
    - Labs: Scr/0, 6, 9, 16/ET
    - ECG: Scr/0-4, 8, 12, 16/ET-17
    E.5.2Secondary end point(s)
    - CGI-I
    - EDE-Q
    - EQ-5D-5L
    - CGI-I
    - EDE-Q
    - EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CGI-I: Visits 1- 16/ET
    - EDE-Q: Visits 5 - 16/ET
    - EQ-5D-5L: Visits 0, 8 and 16/ET
    - CGI-I: Visits 1- 16/ET
    - EDE-Q: Visits 5 - 16/ET
    - EQ-5D-5L: Visits 0, 8 and 16/ET
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Abierto, de optimización de dosis seguido de mantenimiento
    Open-label, Dose Optimization followed by Maintenance
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    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 end of the trial is signified by the last patient finishing the last visit (the Follow-up Visit) of the trial.
    El final del estudio está definido por la fecha de la última visita del último paciente del ensayo (visita de seguimiento)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days9
    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: 530
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 530
    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)
    None
    Ninguno
    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 Decision2013-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-28
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