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    Summary
    EudraCT Number:2012-001172-12
    Sponsor's Protocol Code Number:CQMF149F2202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-10
    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 number2012-001172-12
    A.3Full title of the trial
    A randomized, double-blind, 12-week treatment, parallel-group study to evaluate the efficacy and safety of QMF149 (150 µg/160 µg o.d.) compared with salmeterol xinafoate/fluticasone propionate (50 µg/500 µg b.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
    Estudio aleatorizado, doble ciego y de grupos paralelos de 12 semanas de tratamiento para evaluar la eficacia y la seguridad de QMF149 (150 µg/160 µg 1 vez al día) en comparación con xinafoato de salmeterol/propionato de fluticasona (50 µg/500 µg 2 veces al día) en pacientes con enfermedad pulmonar obstructiva crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of QMF149 vs. salmeterol xinafoate/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)
    Eficacia y seguridad de QMF149 vs. xinafoato de salmeterol/propionato de fluticasona en pacientes con enfermedad pulmonar obstructiva crónica (EPOC)
    A.4.1Sponsor's protocol code numberCQMF149F2202
    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 Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4161 3241111
    B.5.5Fax number+4161 3248001
    B.5.6E-mailclinicaltrial.enquiries@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 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 nameIndacaterol acetate/Mometasone furoate
    D.3.2Product code QMF149
    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 INNAcetato de indacaterol
    D.3.9.1CAS number 1000160-96-2
    D.3.9.2Current sponsor codeQAB149
    D.3.9.3Other descriptive nameAcetato de indacaterol
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFuroato de mometasona
    D.3.9.1CAS number 83919-23-7
    D.3.9.2Current sponsor codeMF
    D.3.9.3Other descriptive nameFUROATO DE MOMETASONA
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 (salmeterol xinafoate/fluticasone propionate) 50/500 microg b.i.d
    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 xinafoate/fluticasone delivered via Accuhaler®
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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 INNPropionato de fluticasona
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive namePROPIONATO DE FLUTICASONA
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXinafoato de salmeterol
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive namesalmeterol
    D.3.9.4EV Substance CodeSUB04314MIG
    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.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
    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 (EPOC)
    E.1.1.1Medical condition in easily understood language
    chronic obstructive pulmonary disease (COPD)
    Enfermedad pulmonar obstructiva crónica (EPOC)
    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 14.1
    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
    The purpose of this study is to explore the efficacy of QMF149 (150/160 µg o.d.) delivered via Concept1 device compared with salmeterol xinafoate/fluticasone propionate (50/500 µg b.i.d.) delivered via Accuhaler® in patients with chronic obstructive pulmonary disease (COPD).
    El objetivo de este estudio es evaluar la eficacia de QMF149 (150/160 µg una vez al día) administrado mediante el dispositivo Concept1 en comparación con xinafoato de salmeterol/propionato de fluticasona (50/500 µg dos veces al día) administrado mediante Accuhaler® en pacientes con enfermedad pulmonar obstructiva crónica (EPOC).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of QMF149 compared with salmeterol
    xinafoate/fluticasone propionate in terms pulmonary function, Transitional Dyspnoea Index (TDI) focal score, St George's Respiratory Questionnaire (SGRQ) and Rescue medication usage.
    To evaluate the safety and tolerability of QMF149 and salmeterol xinafoate/fluticasone propionate during 12 weeks of treatment.
    To compare the efficacy of QMF149 with salmeterol xinafoate/fluticasone propionate in terms of the following exacerbation-related parameters.
    To evaluate the effect of QMF149 compared with salmeterol xinafoate/fluticasone propionate in terms of obstructive sleep apnoea (OSA) by using Medical Outcome Study (MOS) sleep scale after 4 and 12 weeks of treatment.
    To evaluate the effect of QMF149 compared with salmeterol xinafoate/fluticasone propionate in terms of chronic systemic inflammatory syndrome by using inflammatory parameters after 12 weeks of treatment.
    Evaluar eficacia de QMF149 en comparación con xinafoato salmeterol /propionato de fluticasona en términos de función respiratoria: Puntuación focal del Índice de disnea de transición (TDI), puntuación del Cuestionario respiratorio de St George (SGRQ) y uso de medicación de rescate.
    Evaluar seguridad y tolerabilidad de QMF149 y de xinafoato de salmeterol /propionato de fluticasona durante 12s de tto.
    Comparar la eficacia de QMF149 y xinafoato de salmeterol/ propionato de fluticasona sobre parámetros relacionados con la exacerbación.
    Evaluar efecto de QMF149 en comparación con xinafoato de salmeterol/ propionato de fluticasona en cuanto a la apnea obstructiva del sueño (AOS) mediante la escala del sueño del Estudio de resultados médicos (MOS) después de 4 y 12s de tto.
    Evaluar efecto de QMF149 en comparación con xinafoato de salmeterol/ propionato de fluticasona en cuanto al síndrome inflamatorio sistémico crónico mediante los parámetros de inflamación después de 12s de tto.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-Study for PK Sampling, 24-hr Spirometry Profiling, and Plasma Cortisol.
    Version and date is the same as current protocol.
    A target of approximately 60 randomized patients (30 patients per treatment group) is required to participate as a sub-set of patients in serial spirometry, PK and plasma cortisol profiling. An additional Informed Consent Form is required for participation in
    this subgroup. The sub-study will require patients to provide extra blood sampling (for pharmacokinetic and plasma cortisol testing), and perform additional breathing tests for spirometry assessments.
    Subestudio de farmacocinética (FC), perfil espirométrico en 24 horas y cortisol en plasma.
    La versión y fecha es la misma que el protocolo actual.
    Se identificará un subgrupo de 60 pacientes (30 pacientes por grupo de tratamiento) para participar en un estudio de espirometrías seriadas, FC y determinación del cortisol plasmático. Para participar en este subgrupo se necesita otro documento de consentimiento informado.
    Para el subestudio se requerirá que los pacientes proporcionen un muestra extra de sangre (para farmacocinética y análisis de cortisol en plasma) y se llevarán a cabo análisis de respiración adicionales para las evaluaciones de espirometrías.
    E.3Principal inclusion criteria
    1. Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 GOLD Guidelines
    2. Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).
    3. Current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or
    ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for >= 6 months at screening.
    *Other protocol-defined inclusion criteria may apply
    1. Pacientes con EPOC entre moderada y muy grave (GOLD 2 a GOLD 4) de acuerdo con las Guías GOLD 2011.
    2. Pacientes con un FEV1 después del broncodilatador por debajo del 70 % del valor normal previsto y un FEV1 /FVC después del broncodilatador menor de 0,70 en la visita de preinclusión (visita 101).
    3. Fumadores o ex fumadores con antecedentes de tabaquismo de al menos 10 cajetillas años (definido como el número de cajetillas de 20 cigarrillos fumadas al día multiplicado por el número de años que el paciente ha estado fumando; por ejemplo, 10 cajetillas años = una cajetilla al día x 10 años, o media cajetilla al día x 20 años). Por ex fumador se entiende la persona que no fuma desde al menos 6 meses antes de la selección.
    *Aplicarán otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    1. Patients who have had a COPD exacerbation that required treatment
    with antibiotics and/or oral corticosteroids and/or hospitalization in the
    6 weeks prior to screening (Visit 1).
    2. Patients who develop a COPD exacerbation 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.
    3. Patients who have had a respiratory tract infection within 4 weeks
    prior to screening Visit 1.
    4. Patients who develop a respiratory tract infection between screening
    (Visit 1) and treatment (Visit 201) will not be eligible, but will be
    permitted to be rescreened 4 weeks after the resolution of the
    respiratory tract infection.
    5. Patients requiring long term oxygen therapy prescribed for >12 hours
    per day.
    6. Patients with, a) any history of asthma or, b) onset of respiratory
    symptoms prior to age 40 years.
    *Other protocol-defined exclusion criteria may apply
    1. Pacientes que hayan tenido una exacerbación de la EPOC que precisara tratamiento con antibióticos, corticoides orales u hospitalización durante las 6 semanas previas a la selección (visita 1).
    2. Los pacientes que presenten una exacerbación de la EPOC entre la selección (visita 1) y el tratamiento (visita 201) no se considerarán elegibles, pero podrán someterse de nuevo al proceso de selección pasado un mínimo de 6 semanas desde la resolución de la exacerbación de la EPOC.
    3. Pacientes que hayan sufrido una infección del tracto respiratorio en las 4 semanas anteriores a la visita 1 de selección.
    4. Los pacientes que contraigan una infección del tracto respiratorio entre la selección (visita 1) y el tratamiento (visita 201) no podrán participar, pero podrán someterse de nuevo al proceso de selección pasadas 4 semanas desde la resolución de la infección del tracto respiratorio.
    5. Pacientes que necesiten oxigenoterapia prolongada prescrita durante más de 12 horas al día.
    6. Pacientes con: a) antecedentes de asma, o bien b) síntomas respiratorios aparecidos antes de los 40 años de edad.
    *Aplicarán otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Trough Forced Expiratory Volume in one second (FEV1).

    Outcome Measure Description: Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.
    Volumen espiratorio máximo en el primer segundo (FEV1) valle.

    Descripción de medidas de resultados: Las espirometrías se llevan a cabo de acuerdo con el estándar global. El FEV1 valle se define como el promedio de los valores determinados 23 horas y 10 minutos y 23 horas y 45 minutos después de la dosis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 12 weeks
    Más de 12 semanas
    E.5.2Secondary end point(s)
    Trough FEV1.
    FEV1 at each timepoint
    FVC at each timepoint
    FEV1 AUC (5 min-4 h), (5 min-24 h)
    The usage of rescue medication (short acting Beta2-agonist)
    Peak FEV1.
    Patient reported outcome measures: SGRQ (St. George's Respiratory Questionnaire)
    Patient reported outcome measures: TDI (Transitional Dyspnoea Index)
    Patient reported outcome measures: COPD Assessment Test
    Safety and tolerability.
    FEV1 valle
    FEV1 en cada tiempo
    Capacidad vital forzada (FVC) en cada tiempo
    AUC normalizada del FEV1 (5 min 4 h), (5 min 24 h)
    Uso de medicación de rescate (agonista beta2 de corta duración)
    FEV1 máximo
    Medidas de resultado informadas por el paciente: Cuestionario de St George para enfermedades respiratorias (SGRQ)
    Medidas de resultado informadas por el paciente: Índice de disnea de transición (TDI)
    Medidas de resultado informadas por el paciente: Prueba de evaluación de la EPOC
    Seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    over 12 weeks
    Más de 12 semanas
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Australia
    Belgium
    Bulgaria
    Denmark
    Finland
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Malaysia
    Netherlands
    Poland
    Romania
    Singapore
    South Africa
    Spain
    Sweden
    Thailand
    Turkey
    Vietnam
    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
    LSLV (Last Subject, Last Visit)
    Último paciente, última visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 576
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 576
    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)
    Patients completing the treatment period will not be given further access to study drug because the risk benefit ratio will not have been substantiated by that time and there are already other marketed therapeutic alternatives available to treat these patients.
    Los pacientes que completen el período de tratamiento ya no tendrán acceso al fármaco del estudio porque aún no se habrá confirmado la relación entre los riesgos y los beneficios y existen en el mercado otras alternativas terapéuticas para ellos.
    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 Decision2013-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
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