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    Summary
    EudraCT Number:2011-005399-40
    Sponsor's Protocol Code Number:20110233
    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:2013-04-09
    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 number2011-005399-40
    A.3Full title of the trial
    A two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
    Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
    Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia
    Estudio de 2 partes de fase 2/3 para evaluar la seguridad, tolerabilidad y eficacia de AMG 145 en sujetos con hipercolesterolemia familiar homocigótica
    Parte A - Estudio piloto multicéntrico, de un solo grupo y abierto para evaluar la seguridad, tolerabilidad y eficacia de AMG 145 en sujetos con hipercolesterolemia familiar homocigótica
    Parte B - Estudio multicéntrico, doble ciego, aleatorizado y controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 145 en sujetos con hipercolesterolemia familiar homocigótica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemia
    Ensayo Clínico para evaluar la seguridad, tolerabilidad y eficacia de AMG 145 en sujetos con hipercolesterolemia familiar homocigótica.
    A.4.1Sponsor's protocol code number20110233
    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 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 nameAMG 145
    D.3.2Product code AMG 145
    D.3.4Pharmaceutical form Solution for injection
    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 INNn/a
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 145
    D.3.9.3Other descriptive nameAMG 145
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    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
    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
    Homozygous familial hypercholesterolaemia
    Hipercolesterolemia familiar homocigótica.
    E.1.1.1Medical condition in easily understood language
    Hypercholesterolemia (high cholesterol), familial
    Hipercolesterolemia (colesterol alto), familiar.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057100
    E.1.2Term Homozygous familial hypercholesterolaemia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: To characterize the effect of 12 weeks of subcutaneous (SC) AMG 145 on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with homozygous familial hypercholesterolemia (HoFH)
    Part B: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 compared with placebo on percent change from baseline in LDL-C in subjects with HoFH
    Parte A: describir el efecto de 12 semanas de tratamiento con AMG 145 por vía subcutánea (SC) en el cambio porcentual desde el valor basal del colesterol ligado a lipoproteínas de baja densidad (C-LDL) en sujetos con hipercolesterolemia familiar homocigótica.
    Parte B: evaluar el efecto de 12 semanas de tratamiento con AMG 145 por vía subcutánea (SC), en comparación con placebo, en el cambio porcentual desde el valor basal del C-LDL en sujetos con hipercolesterolemia familiar homocigótica.
    E.2.2Secondary objectives of the trial
    Part A:
    - To evaluate the safety and tolerability of AMG 145 SC in subjects with HoFH
    - To assess the effects of 12 weeks of AMG 145 SC on absolute change in LDL-C, and percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B
    (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio in subjects with HoFH
    - To evaluate AMG 145 pharmacokinetics and absolute change in PCSK9 in subjects with HoFH
    Part B:
    -To evaluate the safety and tolerability of AMG 145 SC compared with placebo in subjects with HoFH
    - To assess the effects of 12 weeks of AMG 145 SC, compared with placebo, on absolute change in LDL-C, and percent change in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, and ApoB/Apolipoprotein A-1 (ApoA1) ratio in subjects with HoFH
    - To evaluate AMG 145 pharmacokinetics and absolute change in PCSK9 in subjects with HoFH
    A:Evaluar la seguridad y tolerabilidad de AMG 145 SC en sujetos con hipercolesterolemia familiar homocigótica.
    Evaluar los efectos de 12s de tratamiento con AMG145 SC en el cambio absoluto del C-LDL, el cambio porcentual en el colesterol ligado a lipoproteínas de no alta densidad (C-no-HDL), la apolipoproteína B (ApoB), la relación colesterol total/C-HDL y la relación ApoB/apolipoproteína A-1 (ApoA1) en sujetos con hipercolesterolemia familiar homocigótica.
    B:Evaluar la seguridad y tolerabilidad de AMG145 SC, en comparación con placebo, en sujetos con hipercolesterolemia familiar homocigótica.
    Evaluar los efectos de 1 de tratamiento con AMG145 SC, en comparación con placebo, en el cambio absoluto del C-LDL, el cambio porcentual en el colesterol ligado a lipoproteínas de no alta densidad (C-no-HDL), la apolipoproteína B (ApoB), la relación colesterol total/C-HDL y la relación ApoB/apolipoproteína A-1 (ApoA1) en sujetos con hipercolesterolemia familiar homocigótica.
    Ver Protocolo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic sub-study.
    This sub-study will investigate potential correlations of study data including the subject response to AMG 145 with genetic variation in markers of proprotein convertase subtilisin/kexin type 9 (PCSK9) signaling, low-density lipoprotein receptor (LDLR) turnover, cholesterol metabolism, inflammation, and plaque stability.
    Sub-estudio de Farmacogenética
    Este subestudio investigará las posibles correlaciones de los datos del estudio incluyendo la respuesta de los sujetos a AMG 145 con variaciones genéticas en marcadores de la proproteína convertasa subtilisina kexina tipo 9 (PCSK9), reciclado del receptor de la lipoproteína de baja densidad (LDLR), metabolismo del colesterol, inflamación y estabilidad de la placa.
    E.3Principal inclusion criteria
    ? Subject has provided informed consent.
    ? Male or female ? 12 to ? 65 years of age
    ? Diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL cholesterol concentration greater than 500 mg/dl (13 mmol/L) together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents.
    ? On a stable on a low-fat diet and taking pre-existing lipid-lowering therapies (such as statins, cholesterol-absorption inhibitors, bile-acid sequestrants or nicotinic acid, or combinations thereof) for at least 4 weeks, with fasting central lab LDL cholesterol concentration > 130 (3.4 mmol/L)
    ? Fasting triglycerides ? 400 mg/dL (4.5 mmol/L) by central laboratory at screening
    ? Bodyweight of 40 kg or greater at screening
    El sujeto ha dado su consentimiento informado.
    Hombre o mujer de >= 12 a ? 65 años de edad.
    Diagnóstico de hipercolesterolemia familiar homocigótica por confirmación genética o un diagnóstico clínico basado en una historia clínica de concentración de colesterol LDL no tratada mayor de 500 mg/dL (13 mmol/L) y un xantoma antes de los 10 años de edad o evidencia de hipercolesterolemia familiar heterocigótica en ambos padres.
    Mantener estables una dieta baja en grasas y la administración de los tratamientos hipolipemiantes previos (como estatinas, inhibidores de la absorción de colesterol, secuestradores de ácidos biliares, ácido nicotínico o combinaciones de estos) durante al menos 4 semanas, con una concentración de colesterol LDL en ayunas del laboratorio central >130 mg/dL (3,4 mmol/L).
    Triglicéridos en ayunas ? 400 mg/dL (4,5 mmol/L), determinados en el laboratorio central.
    Peso corporal de 40 kg (88 lbs) o más en la selección.
    E.4Principal exclusion criteria
    ? LDL or plasma apheresis within 8 weeks prior to enrollment
    ? Use of Mipomersen within 5 months of screening
    ? NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30%
    ? Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to enrollment
    ? Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to enrollment
    ? Planned cardiac surgery or revascularization within 20 weeks of screening
    ? Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 180 mmHg or diastolic BP (DBP) > 110 mmHg, confirmed with repeat measurement
    ? Subject requires uptitration of their current statin dose within 4 weeks of screening (these subjects can be uptitrated and rescreened 1 month later)
    ? Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening
    ? Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the ULN as determined by central laboratory analysis at screening
    ? Unexplained CK > 5 times the ULN at screening, confirmed by a repeat measurement at least 1 week apart
    ? Known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
    ? Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment
    ? Unreliability as a study participant based on the investigator's (or designee?s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
    ? Currently 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)
    ? Female subject who is not willing to use at least 1 highly effective method of birth control during treatment and for an additional 15 weeks after the end of treatment unless subject is sterilized or postmenopausal;
    ? Subject is pregnant or breast feeding, or planning to become pregnant during treatment and/or within 15 weeks after the end of treatment
    ? Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years
    ? Subject has previously received AMG 145 or any other investigational therapy to inhibit inhibiting PCSK9
    ? Known sensitivity to any of the products to be administered during dosing
    ? Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator?s knowledge.
    ? Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
    -Aféresis plasmática o de LDL en las 8 semanas previas a la inclusión.
    -Uso de Mipomersen en los 5 meses anteriores a la selección.
    -Insuficiencia cardíaca en clase III ó IV de la NYHA o la última fracción de eyección ventricular izquierda conocida < 30%.
    -Arritmia cardíaca grave no controlada definida como taquicardia ventricular recurrente y altamente sintomática, fibrilación auricular con respuesta ventricular rápida o taquicardia supraventricular que no se controla con medicamentos, en los últimos 3 meses antes de la inclusión.
    -Infarto de miocardio, angina inestable, intervención coronaria percutánea (ICP), injerto de derivación de arteria coronaria (IDAC) o infarto cerebral en los 3 meses previos a la inclusión.
    -Revascularización o cirugía cardíaca planificadas en las 20 semanas previas a la selección.
    -Hipertensión incontrolada definida como presión arterial sistólica en reposo (PAS) > 180 mmHg o PA diastólica (PAD) > 110 mmHg, confirmada con mediciones repetidas.
    -Sujetos que necesiten un ajuste ascendente de su dosis de estatina actual en las 4 semanas anteriores a la selección (tras el ajuste ascendente de la dosis estos sujetos pueden ser reseleccionados al cabo de 1 mes).
    -Insuficiencia renal grave o moderada, definida como una tasa de filtración glomerular estimada (TFGe) < 30 mL/min/1,73 m2 en la selección.
    -Enfermedad hepática activa o disfunción hepática, definida por aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 3 veces el LSN, determinadas en el análisis del laboratorio central en la selección.
    -CK > 5 veces el LSN inexplicable en la selección, confirmada mediante mediciones repetidas con 1 semana de separación como mínimo.
    -Infección activa conocida o disfunción importante hematológica, renal, metabólica, gastrointestinal o endocrina a criterio del investigador.
    -Diagnóstico de trombosis venosa profunda o embolismo pulmonar en los 3 meses previos a la inclusión.
    -Falta de fiabilidad como participante del estudio según los conocimientos del investigador (o persona designada) sobre el sujeto (por ejemplo, abuso de alcohol y otras drogas, incapacidad o falta de voluntad de seguir el protocolo, o psicosis).
    -Que esté actualmente incluido en otro estudio de investigación de un fármaco o dispositivo, que hayan pasado menos de 30 días desde la finalización de otros estudios de investigación de fármacos o dispositivos, o que esté recibiendo otros agentes en investigación.
    -Mujer que no está dispuesta a utilizar al menos un método anticonceptivo altamente eficaz durante el tratamiento y durante las 15 semanas posteriores al final del tratamiento, salvo que sea posmenopáusica o estéril.
    ?La menopausia se define como 12 meses seguidos de amenorrea espontánea en una mujer ? 55 años o 12 meses seguidos de amenorrea espontánea con un nivel de hormona folículoestimulante (FSH) > 40 UI/L (o según la definición de "intervalo posmenopáusico" del laboratorio en cuestión) en una mujer < 55 años a menos que haya sido sometida a una ovariectomía bilateral.
    ?Los métodos anticonceptivos altamente eficaces incluyen abstinencia, píldoras anticonceptivas, inyecciones, implantes o parches, dispositivos intrauterinos (DIU), actividad sexual con un hombre que se haya sometido a una vasectomía, preservativos o dispositivos oclusivos (diafragma o capuchón cervical/en bóveda) utilizados con espermicida.
    -Mujer embarazada o en período de lactancia, o que planee quedarse embarazada durante el tratamiento y/o en las 15 semanas posteriores al fin del tratamiento.
    -Tumor maligno (excepto cáncer de piel no melanomatoso, carcinoma cervical in situ, carcinoma ductal de mama in situ o carcinoma de próstata en estadio 1) en los últimos 5 años.
    -El sujeto ha recibido previamente AMG 145 o cualquier otro tratamiento en investigación para inhibir la inhibición de la PCSK9.
    Sensibilidad conocida a alguno de los productos que se administrarán durante la dosificación.
    -Según informan el sujeto y el investigador, el sujeto no estará disponible para las visitas o procedimientos del estudio requeridos por el protocolo.
    -El sujeto presenta un trastorno de cualquier tipo que, según la opinión del investigador, puede comprometer su capacidad para proporcionar el consentimiento informado escrito y/o cumplir con los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Part A & Part B: The percent change LDL-C from baseline to week 12.
    la variable principal es el cambio porcentual en el C-LDL entre el valor basal y la semana 12 (parte A y parte B).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 12
    Desde el valor basal a la semana 12
    E.5.2Secondary end point(s)
    ? Change in LDL-C at week 12 (Part A and Part B)
    ? Percent change in non-HDL-C at week 12 (Part A and Part B)
    ? Percent change in ApoB at week 12 (Part A and Part B)
    ? Percent change in the total cholesterol/HDL-C ratio at week 12 (Part A and Part B)
    ? Percent change in ApoB/ApoA1 ratio at week 12 (Part A and Part B)
    ? Response rate of subjects with 15% or greater reduction in LDL-C from baseline to Week 12 (Part A only)
    ? Change in PCSK9 at week 12 (Part A and Part B)Subject incidence of treatment emergent adverse events
    Cambio en el C-LDL entre el valor basal y la semana 12 (parte A y parte B).
    Cambio porcentual en el C-no-HDL entre el valor basal y la semana 12 (parte A y parte B).
    Cambio porcentual en la ApoB entre el valor basal y la semana 12 (parte A y parte B).
    Cambio porcentual en la relación colesterol total/C-HDL entre el valor basal y la semana 12 (parte A y parte B).
    mbio porcentual en la relación ApoB/ApoA1 entre el valor basal y la semana 12 (parte A y parte B).
    Tasa de respuesta en sujetos con una reducción del 15% o mayor del C-LDL entre el valor basal y la semana 12 (solo parte A).
    Cambio en la PCSK9 entre el valor basal y la semana 12 (parte A y parte B).
    Incidencia de acontecimientos adversos derivados del tratamiento en los sujetos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Change from baseline in LDL-C at week 12: from baseline to week 12
    - Percent change from baseline in non-HDL-C at week 12: from baseline to week 12
    - Percent change from baseline in ApoB at week 12: from baseline to week 12
    - Percent change from baseline in the total cholesterol/HDL-C ratio at week 12: from baseline to week 12
    - Percent change from baseline in ApoB/ApoA1 ratio at week 12: from baseline to week 12
    - Response rate of subjects with 15% or greater reduction in LDL-C from baseline to Week 12 (Part A only): from baseline to week 12
    - Change in PCSK9 at week 12 (Part A and Part B)Subject incidence of treatment emergent adverse events: from baseline to week 12
    - En la semana 12 cambio desde el valor de C-LDL basal: desde el nivel basal a la semana 12.
    -En la semana 12 cambio desde el valor de C-no-HDL basal: desde el nivel basal a la semana 12.
    - En la semana 12 cambio porcentual desde el valor basal de ApoB: desde el nivel basal a la semana 12.
    -En la semana 12 cambio porcentual desde el valor basal en la relación colesterol total/C-HDL: desde el nivel basal a la semana 12.
    -En la semana 12 cambio porcentual desde el valor basal en la relación ApoB/ApoA1: desde el nivel basal a la semana 12.
    -En la semana 12 tasa de respuesta en sujetos con una reducción del 15% o mayor del C-LDL: desde el nivel basal a la semana 12.
    -En la semana 12 cambio en la PCSK9: desde el nivel basal a la semana 12.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    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
    Parte A-Abierto, Ciego; Parte B-Doble ciego, grupos paralelos.
    Part A - Open label, single blind; Part B - double blind, parallel group
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Austria
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Hong Kong
    Malaysia
    New Zealand
    South Africa
    Spain
    Turkey
    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
    ültima visita, último paciente
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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 Yes
    F.1.1Number of subjects for this age range: 15
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 51
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 67
    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)
    The plans for treatment or care after the subject has ended participation in the trial are not different from the expected normal treatment of this condition.
    Los planes de tratamiento para el paciente después de haber terminado la participación en el estudio no son diferentes de los habituales esperados para esta condición.
    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 Decision2013-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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