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    Summary
    EudraCT Number:2015-000981-70
    Sponsor's Protocol Code Number:1408143
    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:2016-01-13
    Trial 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 number2015-000981-70
    A.3Full title of the trial
    A multicentre, randomised, double-blind, controlled, phase IIIb study to assess the efficacy and safety of Rivaroxaban 10mg od versus Enoxaparin 4000 IU for VTE PROphylaxis in NOn Major Orthopaedic Surgery. The PRONOMOS study
    Estudio en fase IIIb multicéntrico, aleatorizado, doble ciego y controlado, para evaluar la eficacia y seguridad de Rivaroxaban 10 mg frente a Enoxaparina 4.000 UI para la profilaxis de TEV en cirugía ortopédica menor. Estudio PRONOMOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which patients hospitalized for non-major orthopaedic surgery and requiring treatment to prevent blood clots in legs due to immobilization may be assigned randomly to receive either Rivaroxaban caps or Enoxaparin injections to compare the efficacy and safety of the 2 treatments.
    Un estudio en el que pacientes hospitalizados para cirugía ortopédica menor que requieren tratamiento para prevenir coágulos de sangre en las piernas debido a la inmovilización, pueden ser asignados aleatoriamente a recibir cápsulas de Rivaroxaban o injecciones de Enoxaparin para comparar la eficacia y seguridad de los 2 tratamientos.
    A.3.2Name or abbreviated title of the trial where available
    PRONOMOS
    PRONOMOS
    A.4.1Sponsor's protocol code number1408143
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02401594
    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 SponsorCentre Hospitalier Universitaire de Saint-Etienne
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street Addressc/ Rufino González 14, Esc. 1ª - 2º D
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913275025
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.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 Xarelto 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNRivaroxaban
    D.3.9.3Other descriptive nameAnticoagulant
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Clexane 4000 IU / 0.4 mL
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    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 INNEnoxaparin
    D.3.9.3Other descriptive nameAnticoagulant
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Venous Thromboembolism Prophylaxis
    Profilaxis tromboembolismo venoso
    E.1.1.1Medical condition in easily understood language
    Prevention of blood clot within a vein
    Prevención de coágulo de sangre dentro de una vena.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 demonstrate the non-inferiority of rivaroxaban 10 mg versus Enoxaparin 4000 IU with respect to the occurrence of major venous thromboembolism (VTE) up to the end of treatment (e.g. removal of the plaster cast or brace). The study is powered to further demonstrate the superiority of Rivaroxaban 10mg once daily versus standard of care with respect to the occurrence of the primary endpoint. This superiority analysis will be performed only if the primary objective of non-inferiority is met.
    Demostrar la no inferioridad de rivaroxabán 10 mg frente a enoxaparina 4.000 UI respecto a la incidencia de TEV importantes hasta el final del tratamiento (por ejemplo, retirada de la escayola o tablilla). La potencia del estudio debería revelar la superioridad de Rivaroxabán 10 mg una vez al día respecto a la incidencia del criterio de valoración principal. El análisis de superioridad solo se realizará si se ha cumplido el objetivo principal de no inferioridad.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the safety of rivaroxaban compared to enoxaparin in terms of:
    1- Major bleeding
    2- Clinically relevant non-major bleeding
    3- Thrombocytopenia
    4- All cause mortality during treatment
    Objetivos secundarios del estudio
    Los objetivos secundarios del estudio son evaluar la seguridad de rivaroxabán frente a la de enoxaparina en términos de:
    1. Hemorragia mayor
    2. Hemorragia menor clínicamente relevante
    3. Trombocitopenia
    4. Mortalidad por cualquier causa durante el tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent form,
    2. Age ? 18 years,
    3. Hospitalised for non-major orthopaedic surgery of the lower limbs and requiring thromboprophylaxis according to the investigators judgement on VTE risk such Achilles? repair, knee, tibial plateau, femur (non femoral head), tibial and ankle fractures and tibial osteotomy, tibial transposition, arthrodesis of leg articulation, ligament repair of the knee with a planned immobilisation or partial weight-bearing for more than 2 weeks, ligament repair of the ankle or any elective orthopaedic limb surgery requiring thromboprophylaxis).
    4. An intended duration of treatment for at least 2 weeks.
    1-Formulario de consentimiento informado firmado y fechado.
    2- Edad ? 18 años.
    3-Ingreso en el hospital por cirugía ortopédica menor de miembros inferiores que precise tromboprofilaxis según el criterio del investigador por riesgo de TEV, como reparación del tendón de Aquiles, fractura de rodilla, de platillo tibial, de fémur (excepto la cabeza femoral), de tibia y de tobillo, osteotomía tibial, trasposición de la tuberosidad tibial, artrodesis de articulación de la pierna, ligamentoplastia de rodilla con inmovilización o carga de peso parcial durante más de 2 semanas, ligamentoplastia de tobillo o cualquier otra cirugía ortopédica programada que requiera tromboprofilaxis.
    4- La duración prevista del tratamiento es de al menos 2 semanas.
    E.4Principal exclusion criteria
    1.Major orthopaedic surgery: Hip and Knee replacement, femoral neck and trochanteric fractures, spine surgery,
    2.Polytrauma (each lesion being individually life-threatening) or any life-threatening lesions,
    3.Low risk surgery without patient VTE risk: foot surgery (Hallux Valgus), material removal, Anterior Cruciate Ligament with less than 15 days of immobilization or before weight bearing
    4.Time between hospitalisation and surgery greater than 36 hours,
    5.More than one injection of LMWH since the end of surgery
    6.Women of childbearing potential not using a reliable contraceptive method throughout the study period (a list of reliable contraceptive methods is provided in the accompanying SPM),
    7.Women pregnant or breast-feeding during the study period,
    8.Body weight less than 50 kg (to avoid bleeding over risk) or over 120 kg,
    9.Treatment with VKA therapy or DOAs,
    10.Concomitant treatment with clopidogrel, prasugrel and ticagrelor,
    11.Use of strong inhibitors of both CYP3A4 and P-gp, i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole
    12.Platelet count < 100 Giga/L,
    13.Documented history of acquired or inherited bleeding disorder (e.g., von Willebrand's disease),
    14.Severe renal failure with calculated creatinine clearance (Cockcroft Formula) < 30 mL/min,
    15.Severe hepatic insufficiency with prothrombin time < 60% or liver impairment associated with coagulation disorders,
    16.History of heparin induced thrombocytopenia,
    17.Any other current significant medical condition that might interfere with treatment evaluation according to the investigator?s judgement,
    18.Known hypersensitivity or other severe reaction to any component of the investigational medicinal product(s),
    19.Participation in another clinical study involving an investigational medicinal product within 30 days prior to inclusion or concomitantly with this study,
    20.Active bleeding or contraindication to anticoagulant therapy
    21.Chronic alcoholic intoxication, (cirrhotic patient)
    22.Anticipated poor compliance of subject with study procedures
    1-Cirugía ortopédica mayor: artroplastia total de cadera o rodilla, fracturas de cuello femoral y trocánter, cirugía de columna.
    2- Politraumatismo (siendo cada lesión individual potencialmente mortal) o cualquier lesión potencialmente mortal.
    3- Cirugía de bajo riesgo sin ningún riesgo de trombosis venosa: cirugía del pie (hallux valgus), retirada de material, ligamentos cruzados anteriores con menos de 15 días de inmovilización o antes de poder volver a cargar peso.
    4- Tiempo entre el ingreso en el hospital y la aleatorización superior a 36 horas.
    5- Más de una inyección de HBPM desde el final de la operación.
    6- Mujeres en edad fértil que no utilicen un método anticonceptivo fiable durante todo el estudio (la lista de métodos anticonceptivos fiables se proporciona en el folleto complementario).
    7- Mujeres embarazadas o en período de lactancia durante el estudio.
    8-Peso corporal inferior a 50 kg (para evitar aumentar el riesgo de hemorragia) o superior a 120 kg.
    9-Tratamiento con AVK o anticoagulantes orales directos.
    10-Tratamiento concomitante con clopidogrel, prasugrel o ticagrelor.
    11-Uso de potentes inhibidores tanto del CYP3A4 como de la P-gp, es decir, todos los inhibidores de la proteasa y los siguientes antimicóticos azólicos: ketoconazol, itraconazol, voriconazol, posaconazol.
    12-Recuento de plaquetas < 100 Giga/l.
    13-Antecedentes documentados de trastornos de la coagulación adquiridos o hereditarios (por ejemplo, von Willebrand).
    14-Insuficiencia renal grave con aclaramiento de creatinina calculado (fórmula de Cockcroft) < 30 ml/min.
    15-Insuficiencia hepática grave con tiempo de la protrombina < 60 % o insuficiencia hepática asociada a trastornos de la coagulación.
    16-Antecedentes de trombocitopenia inducida por heparina.
    17- Cualquier otra enfermedad actual que pueda interferir en la evaluación del tratamiento a criterio del investigador.
    18-Hipersensibilidad conocida o cualquier reacción grave a uno de los componentes del fármaco en investigación.
    19-Participación en cualquier otro estudio clínico que implique un fármaco en investigación en los 30 días previos a la inclusión en el estudio o en combinación con el estudio.
    20-Episodio hemorrágico o contraindicación para el uso de tratamiento anticoagulante.
    21-Alcoholismo crónico (paciente cirrótico)
    22- Cumplimiento esperado deficiente del paciente con los procedimientos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome, major VTE, is the composite of proximal Deep Venous Thrombosis (DVT) (asymptomatic and symptomatic), symptomatic events (distal and proximal DVT, Pulmonary Embolism) and VTE related deaths up to the end of the treatment period.
    El criterio de valoración principal de la eficacia, acontecimientos tromboembólicos venosos (TEV) importantes, es un criterio de valoración compuesto que incluye trombosis venosas profundas (TVP) proximales (asintomáticas y sintomáticas), acontecimientos sintomáticos (TVP distal y proximal, embolias pulmonares) y muertes relacionadas con TEV hasta el final del período de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to the end of the treatment period
    hasta la finalización del periodo de tratamiento
    E.5.2Secondary end point(s)
    1- Major bleeding. Major bleeding is defined as a bleeding event that meets at least one of the following criteria [5]:
    -fatal bleeding;
    -critical bleeding (intracranial, intraocular, intraspinal, pericardial, retroperitoneal);
    -clinically overt bleeding (at surgical or extrasurgical site) associated with a decrease in the haemoglobin level of more than 2 g/dL (20 g/l; 1.24 mmol/L) compared with the pre-randomization level;
    -clinically overt bleeding (at surgical or extrasurgical site) leading to transfusion of two or more units of whole blood or packed cells;
    -bleeding located at the surgical site and leading to re-operation or to any unusual medical intervention or procedure for relief (e.g. draining or puncture of an haematoma at the surgical site, transfer to an ICU or emergency room).
    2- Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding and corresponds to any bleeding necessitating medical intervention or a specific, unscheduled consultation or treatment discontinuation, or resulting in a deterioration of the subject?s quality of life. Some examples of clinically significant bleeding are given below:
    -Epistaxis that lasts more than five minutes or recurrent or necessitates packing,
    -Spontaneous macroscopic haematuria or haematuria lasting more than 24 hours after instrumentation,
    -Gastrointestinal haemorrhage (melena or rectorrhagia),
    -Haemoptysis,
    -Subcutaneous haematoma > 100 cm².
    3- Overt thrombocytopenia: platelet count <100 giga/L or fall ? 50% of the platelet count as compared with the first post-operative count which will be done as local lab for all centres. During the course of the study, platelet count monitoring will be done as per country recommendation and in case of bleedings and recurrent VTE.
    4- All cause mortality during treatment
    All suspected VTEs, deaths, as well as all episodes of bleeding will be evaluated by a central, blinded, independent adjudication committee (ICAC). Adjudication results will be the basis for the final analyses.
    1- Hemorragia intensa. La hemorragia intensa se define como un acontecimiento hemorrágico que cumple al menos uno de los criterios siguientes:
    - Hemorragia mortal;
    - Hemorragia crítica (intracraneal, intraocular, intramedular, pericárdica, retroperitoneal);
    - Hemorragia clínicamente manifiesta (en la zona quirúrgica o fuera de esta) asociada a una reducción en el nivel de hemoglobina de más de 2 g/dl (20 g/l; 1,24 mmol/l) respecto al nivel previo a la aleatorización;
    - Hemorragia clínicamente manifiesta (en la zona quirúrgica o fuera de esta) que dé lugar a transfusión de dos o más unidades de sangre completa o concentrados de células sanguíneas;
    - Hemorragia localizada en la zona quirúrgica y que conlleve una nueva intervención o una intervención o procedimiento médico inusual para el alivio (p. ej., drenaje o punción de un hematoma en la zona quirúrgica, transferencia a la UCI o al servicio de urgencias).
    2- La hemorragia clínicamente relevante menor se define como una hemorragia externa que no cumple los criterios de hemorragia mayor y se corresponde con cualquier hemorragia que precisa una intervención médica específica o una consulta no programada o la interrupción de un tratamiento específico, o que deteriora la calidad de vida del paciente. A continuación se muestran algunos ejemplos:
    - Epistaxis de más de 5 minutos de duración o recidivante y que precisa taponamiento.
    - Hematuria macroscópica espontánea o hematuria de más de 24 horas de duración después de la instrumentación.
    - Hemorragia digestiva (melena o rectorragia).
    - Hemoptisis.
    - Hematoma subcutáneo > 100 cm².
    3- Trombocitopenia manifiesta: recuento de plaquetas < 100 giga/l o reducción ? 50 % en el recuento de plaquetas respecto al primer recuento posoperatorio realizado en los laboratorios locales de todos los centros. Durante el estudio, el recuento de plaquetas se controlará de acuerdo con las recomendaciones específicas de cada país y en casos de hemorragia y TEV recidivante.
    4- Mortalidad por cualquier causa durante el tratamiento.
    Un Comité de adjudicación central independiente (CACI) evaluará de forma enmascarada todas las sospechas de TEV, todas las muertes y todos los episodios hemorrágicos. Los resultados formarán la base de los análisis finales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to the end of the treatment period
    hasta la finalización del periodo de tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA177
    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
    Canada
    Switzerland
    Tunisia
    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
    Ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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: 3400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 state660
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3894
    F.4.2.2In the whole clinical trial 4400
    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)
    Subject completing the study will be treated at hospital or private clinic according to accepted medical practice.
    Los pacientes que completen el estudio serán tratados en un hospital o en una clínica privada de acuerdo con la práctica médica.
    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 Decision2016-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-29
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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