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    Summary
    EudraCT Number:2015-000114-22
    Sponsor's Protocol Code Number:CQVA149A2316
    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:2015-10-30
    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 number2015-000114-22
    A.3Full title of the trial
    A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 ?g o.d.) vs tiotropium (18 ?g o.d.) + salmeterol/fluticasone propionate FDC (50/500 ?g b.i.d.) in patients with moderate to severe COPD
    Estudio multicéntrico, doble ciego, aleatorizado, de grupos paralelos y de 26 semanas de duración para evaluar la eficacia y la seguridad de QVA149 (110/50 µg 1 v/d) respecto a tiotropio (18 µg 1 v/d) + la asociación en dosis fijas de salmeterol/propionato de fluticasona (50/500 µg 2 v/d) en pacientes con EPOC de moderada a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and safety of QVA149 (110/50 ?g o.d.) vs tiotropium (18 ?g o.d.) + salmeterol/fluticasone propionate FDC (50/500 ?g b.i.d.) in patients with moderate to severe COPD
    Estudio multicéntrico, doble ciego, aleatorizado, de grupos paralelos y de 26 semanas de duración para evaluar la eficacia y la seguridad de QVA149 (110/50 µg 1 v/d) respecto a tiotropio (18 µg 1 v/d) + la asociación en dosis fijas de salmeterol/propionato de fluticasona (50/500 µg 2 v/d) en pacientes con EPOC de moderada a grave
    A.4.1Sponsor's protocol code numberCQVA149A2316
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34392479903
    B.5.6E-maileecc.novartis@novartis.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 Ultibro Breezhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameindacaterol maleate/glycopyrronium bromide
    D.3.2Product code QVA149
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDACATEROL MALEATE
    D.3.9.1CAS number 753498-25-8
    D.3.9.2Current sponsor codeQAB149
    D.3.9.4EV Substance CodeSUB30300
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeNVA237
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 Yes
    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 Seretide
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Ltd
    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.3.1Product namesalmeterol/fluticasone
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL
    D.3.9.1CAS number 89365-50-4
    D.3.9.4EV Substance CodeSUB10430MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFLUTICASONE
    D.3.9.1CAS number 90566-53-3
    D.3.9.4EV Substance CodeSUB07760MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    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 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 Spiriva
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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.3.1Product nametiotropium
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTiotropium bromide
    D.3.9.1CAS number 411207-31-3
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21897
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 Yes
    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 placeboInhalation powder, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, pre-dispensed
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, hard capsule
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease (COPD)
    Enfermedad pulmonar obstructiva crónica
    E.1.1.1Medical condition in easily understood language
    COPD is a chronic condition of the lungs which causes people to suffer symptoms such as shortness of breath and coughing.
    EPOC es una enfermedad crónica de los pulmones que causa síntomas tales como dificultad para respirar y tos.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    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 QVA149 (110/50 g o.d.) on trough FEV1 vs. tiotropium (18 G o.d.) + salmeterol/fluticasone propionate FDC (50/500 g b.i.d.) after 26 weeks of treatment in moderate-to-severe COPD patients.
    Para demostrar la no inferioridad de QVA149 (110/50 G od) en el FEV1 valle vs tiotropio (18 G od) + salmeterol / propionato de fluticasona FDC (50/500? G dos veces) después de 26 semanas de tratamiento en moderada pacientes con EPOC a grave.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of QVA149 (110/50 ?g o.d.) compared with tiotropium (18 ?g o.d.) + salmeterol/fluticasone propionate FDC (50/500 ?g b.i.d.) over 26 weeks of treatment in terms of Rate of moderate or severe COPD exacerbations.
    - To evaluate the effect of QVA149 compared with tiotropium + salmeterol/fluticasone propionate FDC on:
    - Trough FEV1 and FVC over 26 weeks
    - Total score of the SGRQ-C after 12 and 26 weeks
    - Total score of the TDI after 12 and 26 weeks
    - Mean use of rescue therapy (number of puffs/day) and the percentage of days without rescue therapy over 26 weeks.
    - To assess the safety of QVA149 vs. tiotropium + salmeterol/fluticasone propionate FDC over 26 weeks (particularly with regard to ECG, laboratory tests, vital signs and adverse events) and tolerability (discontinuation due to adverse events).
    Para evaluar el efecto de QVA149 (110/50? G od) en comparación con tiotropio (18? G od) + salmeterol / propionato de fluticasona FDC (50/500? G bid) más de 26 semanas de tratamiento en términos de tasa de moderada o grave exacerbaciones de la EPOC.
    - Para evaluar el efecto de QVA149 en comparación con tiotropio + salmeterol / propionato de fluticasona FDC en:
    - Comedero FEV1 y FVC más de 26 semanas
    - La puntuación total del SGRQ-C después de 12 y 26 semanas
    - La puntuación total del TDI después de 12 y 26 semanas
    - Mean uso de la terapia de rescate (número de inhalaciones / día) y el porcentaje de días sin tratamiento de rescate más de 26 semanas.
    - Para evaluar la seguridad de QVA149 vs tiotropio + salmeterol / propionato de fluticasona FDC más de 26 semanas (en particular respecto de ECG, pruebas de laboratorio, signos vitales y los eventos adversos) y tolerancia (interrupción debido a eventos adversos).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To assess the safety of QVA149 vs. tiotropium + salmeterol/fluticasone propionate FDC over 26 weeks in a subset of patients in terms of HPA axis function, as determined by 24-hour weighted mean urine cortisol.
    Para evaluar la seguridad de QVA149 vs tiotropio + salmeterol / propionato de fluticasona FDC más de 26 semanas en un subgrupo de pacientes en términos de la función del eje HPA, según lo determinado por 24 horas ponderada cortisol media orina.
    E.3Principal inclusion criteria
    - Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
    - Male and female adults aged ? 40 years.
    - Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3)according to the 2014 GOLD Guidelines.
    - Patients with a post-bronchodilator FEV1?40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC <0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 ?g of salbutamol).
    - Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ? 6 months at screening.
    - Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
    - Pacientes que han firmado formulario de consentimiento informado antes de la iniciación de cualquier procedimiento relacionado con el estudio.
    - Hombres y mujeres adultos de edades?40 años.
    - Los pacientes con moderada a severa obstrucción al flujo aéreo con EPOC estable (Etapa 2 o Etapa 3) de acuerdo con las directrices GOLD 2014.
    - Los pacientes con un post-broncodilatador VEF1 40 y <80% del valor normal predicho, y post-broncodilatador VEF1 / CVF <0,70 en ejecución en Visita 101. (Publicar refiere a 15 minutos después de la inhalación de 400 g de salbutamol? ).
    - Actual o ex fumadores que tienen una historia de tabaquismo de al menos 10 años de carga (por ejemplo, 10 años paquete = 1 paquete / día x 10 años, o ½ paquete / día x 20 años). Un ex fumador se define como un paciente que no ha fumado durante? 6 meses en el cribado.
    - Los pacientes que están en tratamiento de triple, al menos durante los últimos 6 meses (LAMA + LABA / ICS).
    E.4Principal exclusion criteria
    - Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don?t meet the acceptability
    criteria)
    - Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
    - Patients who developed a COPD exacerbation of any severity either 6 weeks before the
    screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
    - Pacientes que no han logrado resultados de la espirometría aceptables en la visita 101 de acuerdo con la ATS (American Thoracic Society) / ERS (European Respiratory Society) criterios de aceptabilidad (una nueva prueba se puede realizar en pacientes que don t conocer la aceptabilidad?
    criterios)
    - Los pacientes que han tenido más de una exacerbación de la EPOC que requiere tratamiento con antibióticos y / o corticosteroides orales y / o la hospitalización en el último año antes de la Visita 1.
    - Los pacientes que desarrollaron una exacerbación de la EPOC de cualquier gravedad, ya sea 6 semanas antes de la
    cribado (Visita 1) o entre el cribado (visita 1) y tratamiento (visita 201) no serán elegibles, pero se le permitirá volver a ser examinados después de un mínimo de 6 semanas después de la resolución de la exacerbación de la EPOC.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline in post-dose trough FEV1
    Cambio desde el inicio en la post-dosis FEV1 valle media
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 26
    Semana 26
    E.5.2Secondary end point(s)
    - Rate of moderate to severe COPD exacerbations requiring treatment with systemic glucocorticosteroids and/or antibiotics at 26 weeks
    - Rate of moderate to severe COPD exacerbations requiring hospitalisation at 26 weeks
    - Trough FEV1 and FVC at 26 weeks
    - Total St. George's Respiratory Questionnaire score at 12 weeks and 26 weeks
    - Total Transitional Dyspnea Index score at 12 weeks and 26 weeks
    - Number of puffs of rescue medication at 26 weeks
    - HPA axis function at 26 weeks
    - Safety and tolerability at 26 weeks
    - Tasa de moderadas a severas exacerbaciones de la EPOC que requieren tratamiento con glucocorticoides sistémicos y / o antibióticos a las 26 semanas
    - Tasa de moderadas a severas exacerbaciones de la EPOC que requieren hospitalización a las 26 semanas
    - Comedero FEV1 y FVC a las 26 semanas
    Puntuación total St. George Respiratory Questionnaire a las 12 semanas y 26 semanas -
    - Puntuación total Índice de disnea de transición a las 12 semanas y 26 semanas
    - Número de inhalaciones de medicación de rescate a las 26 semanas
    - La función del eje HPA a las 26 semanas
    - La seguridad y tolerabilidad a las 26 semanas
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12 and week 26
    Semana 12 y semana 26
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA168
    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
    Argentina
    Austria
    Belgium
    Bulgaria
    Canada
    Colombia
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Greece
    Guatemala
    Hungary
    Italy
    Latvia
    Lithuania
    Mexico
    Netherlands
    Poland
    Romania
    Serbia
    Slovakia
    Spain
    United Kingdom
    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
    LVLS
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 700
    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 state0
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 771
    F.4.2.2In the whole clinical trial 1000
    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)
    All randomized patients, regardless of whether they completed study treatment through Week 26 or discontinued study treatment prior to Week 26, will be contacted 4 weeks after last study visit/treatment for a Safety Follow-up Visit.
    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 Decision2015-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-18
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