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    Summary
    EudraCT Number:2013-000239-28
    Sponsor's Protocol Code Number:D1693C00001
    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:2013-06-10
    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 number2013-000239-28
    A.3Full title of the trial
    DECLARE Dapagliflozin Effect on CardiovascuLAR Events
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes
    DECLARE Efecto de Dapagliflozina en eventos cardiovasculares
    Ensayo multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar el efecto de dapagliflozina 10 mg una vez al día en la incidencia de muerte cardiovascular, infarto de miocardio o ictus isquémico en pacientes con diabetes tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter Trial to Evaluate the Effect of Dapaglliflozin on the Incidence of Cardiovascular Events (DECLARE)
    Ensayo multicentrico para evaluar el efecto de dapaglifozina en la incidencia de eventos cardiovasculares.
    A.3.2Name or abbreviated title of the trial where available
    DECLARE
    DECLARE
    A.4.1Sponsor's protocol code numberD1693C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01730534
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/207/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike, PO Box 15437
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post code19850-5437
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800236993
    B.5.6E-mailinformation.center@astrazeneca.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 Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDapagliflozin
    D.3.2Product code BMS-512148
    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 INNdapagliflozin
    D.3.9.1CAS number 960404-48-2
    D.3.9.2Current sponsor codeBMS-512148-05
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
    D.3.9.4EV Substance CodeSUB90205
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type II Diabetes mellitus
    Diabetes mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Diabetes Type II
    Diabetes tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy will result in a reduction in the incidence of the composite endpoint of cardiovascular death, myocardial infarction (MI), or ischemic stroke in patients with type 2 diabetes mellitus (T2DM) with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM.
    El objetivo principal de eficacia es determinar si, en comparación con el placebo, el tratamiento con dapagliflozina, cuando se añade al tratamiento de base actual, tiene como resultado una reducción del endpoint compuesto de muerte cardiovascular, infarto de miocardio (IM) o ictus isquémico en pacientes con diabetes mellitus tipo 2 (DMT2) con enfermedad cardiovascular establecida o al menos dos factores de riesgo cardiovascular además de la DMT2.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy in patients with T2DM with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM will result in a reduction of:
    · Hospitalization for Congestive Heart Failure
    ·The composite endpoint of cardiovascular death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization.
    · All-cause mortality
    · Body weight from baseline
    El objetivo secundario de eficacia es determinar si, en comparación con el placebo, el tratamiento con dapagliflozina, cuando se añade al tratamiento de base actual en pacientes con DMT2 con enfermedad cardiovascular establecida o al menos dos factores de riesgo cardiovascular además de la DMT2 tendrá como resultado una reducción de:
    ? Hospitalización por insuficiencia cardiaca congestiva
    ? El endpoint compuesto de muerte cardiovascular, IM, ictus isquémico, hospitalización por insuficiencia cardiaca, hospitalización por angina de pecho inestable u hospitalización por cualquier revascularización.
    ? Mortalidad por todas las causas
    ? Peso corporal desde el inicio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients should fulfill the following criteria:
    1. Provision of informed consent prior to any study specific procedures (including run-in)
    2. Female or male aged ? 40 years
    3. Diagnosed with T2DM (See Appendix E for details)
    4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors:
    - Established CV Disease (See Appendix E for details)
    OR
    No known cardiovascular disease AND at least two cardiovascular risk factors in addition to T2DM, defined as:
    - Age > 55 years in men and > 60 in women
    AND presence of at least 1 of the following additional risk factors (see Appendix E for details)
    - Dyslipidemia
    - Hypertension
    - Tobacco use

    5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
    - WOCBP must have a negative urine pregnancy test. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
    - WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
    For inclusion in the optional genetic research, patients must fulfill the criterion specified in Appendix H.
    Para ser incluidos en el ensayo, los pacientes deben cumplir todos los criterios de inclusión siguientes:
    1. Provisión del consentimiento informado antes de cualquier procedimiento específico del ensayo (incluida la preinclusión)
    2. Mujer o varón de ? 40 años
    3. Diagnosticado de DMT2 (Véanse los detalles en el Apéndice E)
    4. Alto riesgo de eventos CV, definido como la presencia de enfermedad CV establecida y/o múltiples factores de riesgo:
    ? Enfermedad CV establecida (véanse los detalles en el Apéndice E)
    O
    Sin enfermedad CV establecida Y al menos dos factores de riesgo cardiovascular además de la DMT2, definida como:
    ? Edad > 55 años en los varones y >60 en las mujeres
    Y presencia de al menos 1 de los siguientes factores de riesgo adicionales (véanse los detalles en el Apéndice E)
    ? Dislipidemia
    ? Hipertensión
    ? Consumo de tabaco

    5. Las MF tomarán precauciones para evitar el embarazo durante todo el ensayo y durante 4 semanas después de tomar la última dosis.
    ? Las MF deben tener una prueba de embarazo en orina negativa. MF se refiere a cualquier mujer que haya tenido menarquia y que no se haya sometido a esterilización quirúrgica satisfactoria (histerectomía, ligadura bilateral de trompas u ooforectomía bilateral) o que no sea posmenopáusica.
    ? Las MF deben estar dispuestas a usar métodos de anticoncepción médicamente aceptados que a criterio del investigador se consideren fiables.
    Para la inclusión en la investigación genética opcional, los pacientes deben cumplir los criterios especificados en el Apéndice H.
    E.4Principal exclusion criteria
    1. Use of the following excluded medications:
    - Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for 2 years or more at any time
    - Current or recent (within 12 months) treatment with rosiglitazone
    - Previous treatment with any SGLT2 inhibitor
    - Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone ?10 mg (e.g., betamethasone ?1.2 mg, dexamethasone ?1.5 mg, hydrocortisone ?40 mg) per day
    2. Acute cardiovascular event[e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained tachycardia <8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the run-in period as long as randomization does not occur within 8 weeks of the event.
    3. Systolic BP >180 or diastolic BP >100 mmHg at randomization
    4. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
    5. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
    6. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
    7. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
    8. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or non-cardiovascular disease (e.g., active malignancy with the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5 years
    9. Pregnant or breast-feeding patients
    10. Involvement in the planning and/or conduct of the study or other dapagliflozin studies (applies to AZ, BMS, Hadassah and Thrombolysis in Myocardial Infarction [TIMI] or representative staff and/or staff at the study site)
    11. Previous randomization in the present study
    12. Active participation in another clinical study with IP and/or investigational device
    13. Individuals at risk for poor protocol or medication compliance during run-in period (reasonable compliance defined as 80 ? 120%, unless a reason for non-compliance is judged acceptable by the Investigator). If for any reason, the Investigator believes that the patient will not tolerate or be compliant with IP or study procedures, the patient should not be randomized and considered a run-in failure.
    Patients will be excluded during run-in and should not be randomized if the following are observed from laboratory or observation during enrollment and run-in assessments:
    14. HbA1c ?12% or HbA1c<6.5%
    15. AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
    16. CrCl < 60 ml/min (based on the Cockroft-Gault equation)
    17. Hematuria (confirmed by microscopy at Visit 1) with no explanation as judged by the Investigator up to randomization. If bladder cancer is identified, patients are not eligible to participate.
    18. Any reason the Investigator believes the patient is not likely to be compliant with the study medication and protocol.
    Exclusion criteria for the optional genetic research
    The exclusion criteria for the optional genetic research are provided in Appendix H.
    Los pacientes no deben cumplir ningún criterio de exclusión en el momento de la aleatorización. Si en el momento de la inclusión, se sabe que el paciente no cumplirá los criterios después de un periodo de preinclusión con placebo adecuado, no debe participar en la preinclusión.
    1.Uso de los siguientes medicamentos no permitidos:
    ? Tratamiento actual o reciente (en los 24 meses previos) con pioglitazona y/o uso de pioglitazona durante 2 años o más en cualquier momento.
    ? Tratamiento actual o reciente (en los 12 meses previos) con rosiglitazona
    ? Tratamiento previo con algún inhibidor del SGLT2
    ? Cualquier paciente que esté recibiendo tratamiento crónico (>30 días consecutivos) con un esteroide oral en dosis equivalente a una dosis de prednisolona por vía oral ?10 mg al día(p. ej., betametasona ?1,2 mg, dexametasona ?1,5 mg, hidrocortisona ?40 mg).
    2.Evento cardiovascular agudo [p. ej., síndrome coronario agudo (SCA), accidente isquémico transitorio (AIT), ictus, cualquier revascularización, insuficiencia cardiaca descompensada, taquicardia continua] <8 semanas antes de la aleatorización. Los pacientes con eventos cardiovasculares agudos pueden participar en el periodo de preinclusión siempre que la aleatorización no tenga lugar en las 8 semanas siguientes al evento.
    3.PA sistólica >180 o PA diastólica >100 mm Hg en la aleatorización
    4.Diagnóstico de diabetes mellitus tipo 1, MODY o diabetes mellitus secundaria
    5.Antecedentes de cáncer de vejiga o de radioterapia en el abdomen inferior o la pelvis en algún momento
    6.Antecedentes de otras neoplasias en los últimos 5 años (exceptuando los cánceres de piel no melanocíticos tratados satisfactoriamente)
    7.Cistitis crónica y/o infecciones del tracto urinario recurrentes (3 o más en el último año)
    8.Toda enfermedad que, en opinión del investigador, podría hacer que el paciente fuera incapaz de completar el estudio, incluidas, entre otras, la enfermedad cardiovascular (insuficiencia cardiaca congestiva de clase IV de la NYHA, arritmias ventriculares recurrentes) o enfermedad no cardiovascular (p. ej., neoplasia activa a excepción del carcinoma basocelular, cirrosis, enfermedad pulmonar crónica, enfermedad autoinmunitaria grave) y/o desenlace probablemente mortal en el plazo de 5 años.
    9.Mujeres embarazadas o en periodo de lactancia
    10.Intervención en la planificación y/o realización del ensayo o en otros ensayos de dapagliflozina (se refiere al personal representante de AZ, BMS, el centro médico Hadassah y el grupo para el estudio de la trombolisis en el infarto de miocardio [TIMI] y/o el personal del centro del ensayo)
    11.Pacientes aleatorizados previamente en el presente ensayo
    12.Participación activa en otro ensayo clínico con un PI y/o con un dispositivo en investigación
    13.Personas con riesgo de incumplimiento del protocolo o del tratamiento durante el periodo de preinclusión (se define como cumplimiento razonable un cumplimiento del 80 ? 120%, a menos que investigador considere aceptable un motivo de incumplimiento). Si por alguna razón, el investigador cree que el paciente no tolerará o incumplirá el tratamiento con el PI o los procedimientos del ensayo, el paciente no será aleatorizado y se considerará un fallo durante la preselección.
    Se excluirá a los pacientes durante la preinclusión y no serán aleatorizados si en las pruebas analíticas o durante el reclutamiento y las evaluaciones de la preinclusión se observa lo siguiente:
    14.HbA1c ?12% o HbA1c <6,5%
    15.AST o ALT >3 veces el LSN o bilirrubina total >2,5 veces el LSN
    16.CrCl < 60 ml/min (basado en la ecuación de Cockfroft-Gault)
    17.Hematuria (confirmada por microscopia en la Visita 1) para la que el investigador no encuentre explicación hasta la aleatorización. Si se detecta cáncer de vejiga, los pacientes no son elegibles para participar.
    18.Cualquier razón por la que el investigador crea que no es probable que el paciente no cumple el tratamiento o el protocolo del ensayo.
    Criterios de exclusión del estudio genético opcional
    Los criterios de exclusión del estudio genético opcional se presentan en el Apénd H.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome efficacy variable of the study is the composite endpoint of cardiovascular death, myocardial infarction, or ischemic stroke (time to first event). These events will be adjudicated.
    La variable principal de eficacia del ensayo es el endpoint compuesto de muerte
    cardiovascular, infarto de miocardio o ictus isquémico (tiempo transcurrido hasta el primer
    evento). Estos eventos serán adjudicados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is event triggered and will be evaluated at 1/3 of primary events, 2/3 of primary events and when we have 100% of the primary events, which means at 463, 927 and 1390 primary events
    E.5.2Secondary end point(s)
    The secondary objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy in patients with T2DM with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM will result in a reduction of:
    · Hospitalization for Congestive Heart Failure
    · The composite endpoint of cardiovascular death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization.
    · All-cause mortality
    · Body weight from baseline
    Otros objetivos de eficacia consisten en determinar si, en comparación con placebo, el
    tratamiento con dapagliflozina, cuando se añade al tratamiento de base actual en pacientes con
    DMT2 y con enfermedad cardiovascular establecida o al menos dos factores de riesgo
    cardiovascular además de la DMT2, tendrá como resultado una reducción de:
    Hospitalización por insuficiencia cardiaca congestiva
    ? El endpoint compuesto de muerte cardiovascular, IM, ictus isquémico, hospitalización
    por insuficiencia cardiaca, hospitalización por angina de pecho inestable u
    hospitalización por revascularización
    ? Mortalidad por cualquier causa
    ? Variación del peso corporal con respecto al momento basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will only be evaluated once ? and that is when the study stops. It could be when we have 1/3 of primary events OR when we have 2/3 of primary events OR when we have all primary events.
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA265
    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
    Australia
    Brazil
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Philippines
    Poland
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    Vietnam
    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
    The end of the study is defined as ?the last visit of the last patient undergoing the study?.
    El final del estudio se define como "la ultima visita del ultimo sujeto que participe en el estudio"
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 8575
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8575
    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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5440
    F.4.2.2In the whole clinical trial 17150
    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)
    Background medication and post-study treatment will not be provided by the Sponsor.
    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 Decision2013-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-11
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