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    Summary
    EudraCT Number:2014-001824-32
    Sponsor's Protocol Code Number:116174
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-001824-32
    A.3Full title of the trial
    A long term, randomised, double blind, placebo-controlled study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus
    Studio a lungo termine, randomizzato, in doppio cieco, controllato verso placebo volto a determinare gli effetti di albiglutide in aggiunta alle terapie ipoglicemizzanti standard sugli eventi cardiovascolari maggiori nei soggetti affetti da diabete mellito di tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long term clinical study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes
    Studio a lungo termine, volto a determinare gli effetti di albiglutide in aggiunta alle terapie ipoglicemizzanti standard sugli eventi cardiovascolari maggiori nei soggetti affetti da diabete mellito di tipo 2
    A.3.2Name or abbreviated title of the trial where available
    Harmony Outcomes
    Harmony Outcomes
    A.4.1Sponsor's protocol code number116174
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/019/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointAlexandra H West
    B.5.3 Address:
    B.5.3.1Street Address1-3, Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, middlesex
    B.5.3.3Post codeUB1 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442089903877
    B.5.6E-mailalex.h.west@gsk.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 Eperzan
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Trading Services
    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 namealbiglutide
    D.3.2Product code GSK716155
    D.3.4Pharmaceutical form Powder and solvent for 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 INNalbiglutide
    D.3.9.1CAS number 782500-75-8
    D.3.9.2Current sponsor codeGSK716155
    D.3.9.3Other descriptive nameALBIGLUTIDE
    D.3.9.4EV Substance CodeSUB120850
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for solution 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
    Diabetes mellitus type 2
    Diabete mellito Tipo 2
    E.1.1.1Medical condition in easily understood language
    Noninsulin-dependent diabetes
    diabete non insulino dipendente
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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
    To determine whether albiglutide is non-inferior with respect to MACE when added to glycaemic standard of care versus standard of care alone.
    Determinare la non inferiorità della terapia con albiglutide in aggiunta al trattamento ipoglicemizzante standard versus lo standard of care da solo sugli eventi MACE
    E.2.2Secondary objectives of the trial
    1. To supplement the primary objective by further characterization of the effects of albiglutide on cardiovascular outcomes.
    2. To evaluate the effects of albiglutide on metabolic management of type 2 diabetes.
    3. To evaluate the safety of albiglutide.
    1. Supportare l’obiettivo primario caratterizzando ulteriormente gli effetti di albiglutide sugli outcome cardiovascolari
    2. Valutazione degli effetti di albiglutide sulla gestione metabolica del diabete di tipo 2
    3. Valutazione della sicurezza di albiglutide
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ELECTRONIC HEALTH RECORDS (EHR) EXPLORATORY SUBSTUDY.
    The study is detailed in Appendix 7 of the main study protocol.
    Objective 1: Assess the barriers to using an EHR-generated list of patients to facilitate trial enrollment.
    Objective 2: Evaluate the fitness of EHR data for use in populating the baseline characteristics in the eCRF
    Objective 3: Explore the use of EHR data to find events of interest during trial follow-up
    STUDIO COMPLEMENTARE SULLE CARTELLE CLINICHE ELETTRONICHE*

    *L’Italia non partecipa a questo sottostudio
    E.3Principal inclusion criteria
    1. Men or women at least 40 years old with a diagnosis of type 2 diabetes.
    2. Established cardiovascular disease, including at least 1 of the following:
    a.Coronary artery disease with EITHER of the following:
    •Documented history of spontaneous myocardial infarction, at least 30 days prior to screening.
    •Documented coronary artery disease (CAD) ≥ 50% stenosis in 1 or more major epicardial coronary arteries, determined by invasive angiography, or history of surgical or percutaneous (balloon and/or stent) coronary revascularization procedure (at least 30 days prior to screening for percutaneous procedures and at least 5 years prior to study entry for coronary artery bypass graft (CABG)).
    b.Cerebrovascular disease – ANY of the following:
    •Documented history of ischaemic stroke, at least 90 days prior to study entry.
    •Carotid arterial disease with ≥ 50% stenosis documented by carotid ultrasound, magnetic resonance imaging or angiography, with or without symptoms of neurologic deficit.
    •Carotid vascular procedure (e.g. stenting or surgical revascularisation), at least 30 days prior to screening.
    c.Peripheral arterial disease (PAD) with EITHER of the following:
    •intermittent claudication and ankle:brachial index < 0.9 in at least one ankle
    •prior non-traumatic amputation, or peripheral vascular procedure (e.g. stenting or surgical revascularisation), due to peripheral arterial ischaemia.
    3. HbA1c >7.0% (53 mmol/mol) based on the most recent documented laboratory assessment measured no more than 6 months prior to randomization. Local laboratory HbA1c values taken as part of usual care are permitted.
    4. Female: subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test for females of reproductive potential only), not breastfeeding, and at least one of the following conditions applies:
    a. Reproductive potential and agrees to follow one of the options listed in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (e.g, combined oral contraceptive pill; see Appendix 2) from 30 days prior to the first dose of study medication and until
    after the last dose of study medication and completion of the follow-up visit. This does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent. Other situations in which contraception in FRP may not need to be mandated should be discussed with the Medical Monitor.
    b. Non-reproductive potential defined as either:
     Pre-menopausal with one of the following: (i) documented tubal ligation; (ii) documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; (iii) hysterectomy; or (iv) documented bilateral oophorectomy, or; Postmenopausal defined as 12 months of spontaneous amenorrhea and age appropriate (i.e. >50 years). In questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) >40 mIU/mL and oestradiol <40 pg/mL (<140 pmol/L) is confirmatory, depending on local laboratory ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment.
    5. Able and willing to provide informed consent.
    1. Uomo o donna di almeno 40 anni con diagnosi di diabete di tipo 2.
    1. Patologia cardiovascolare conclamata, che include almeno uno dei seguenti:
    a. Coronaropatia con UNA delle seguenti:
    • Anamnesi documentata di infarto miocardico spontaneo, almeno 30 giorni prima dello screening.
    • Stenosi ≥50% per coronaropatia (CAD) documentata in una o più arterie coronariche epicardiche maggiori, determinata con angiografia invasiva o anamnesi di procedure di rivascolarizzazione coronarica chirurgica o percutanea (palloncino e/o stent) (almeno 30 giorni prima dello screening per le procedure percutanee e almeno 5 anni prima dello screening per il bypass aortocoronarico [CABG]).
    b. Cerebrovasculopatia – UNA QUALSIASI delle seguenti:
    • Anamnesi documentata di ictus ischemico, almeno 90 giorni prima dell’arruolamento nello studio.
    • Malattia dell’arteria carotide con stenosi 50%, documentata con ecografia della carotide, risonanza magnetica o angiografia, con o senza sintomi di deficit neurologico.
    • Intervento di chirurgia vascolare della carotide (ad es. stent o rivascolarizzazione chirurgica), almeno 30 giorni prima dello screening.
    c. Arteriopatia periferica (PAD) con UNA delle seguenti:
    • Claudicatio intermittens e indice caviglia-braccio <0,9 in almeno una caviglia.
    • Amputazione non traumatica pregressa o procedura interventistica vascolare periferica (ad es. stent o rivascolarizzazione periferica), dovuta a ischemia arteriosa periferica.
    2. HbA1c >7,0% (53 mmol/mol) in base alle valutazioni di laboratorio documentate più recentemente e non oltre i 6 mesi precedenti la randomizzazione. I valori di HbA1c di laboratorio locali misurati nel quadro del trattamento standard sono considerati validi.
    3. Donne: le pazienti di sesso femminile sono idonee a partecipare allo studio se non sono in stato di gravidanza (come confermato dal risultato negativo al test della gonadotropina corionica umana sierica [hCG], solo per le donne in età fertile), non sono in allattamento e soddisfano almeno una delle condizioni seguenti:
    a. Donne potenzialmente fertili e consenzienti a seguire una delle opzioni previste nell’elenco dei metodi altamente efficaci per il controllo delle nascite nelle donne in età fertile (ad es. pillola contraccettiva orale combinata; si veda Appendice 2) a partire da 30 giorni prima della prima dose del farmaco in studio e fino all’ultima assunzione del farmaco e al completamento della visita di follow-up.
    Questa condizione non è necessaria per le donne potenzialmente fertili che hanno rapporti con partner dello stesso sesso, nel caso in cui questo sia il loro stile di vita abituale, o per le pazienti che praticano e continueranno a praticare l’astinenza. Le altre situazioni in cui non è necessario l’impiego di metodi contraccettivi nelle pazienti in età fertile devono essere discusse con il Medical Monitor.
    b. Donne non potenzialmente fertili per:
    • Premenopausa caratterizzata da almeno una delle seguenti: (i) legatura delle tube documentata; (ii) occlusione tubarica per via isteroscopica con follow-up di conferma di occlusione tubarica bilaterale; (iii) isterectomia; (iv) ovariectomia bilaterale documentata; oppure
    • Postmenopausa definita da 12 mesi di amenorrea spontanea ed età >50 anni. Nei casi dubbi è possibile ottenere la conferma in campioni ematici mediante la documentazione di un livello di ormone follicolo-stimolante (FSH) >40 mUI/mL e di estradiolo <40 pg/mL (<147 pmol/L), secondo i parametri in uso nel laboratorio che esegue le analisi. Le donne in terapia ormonale sostitutiva (HRT) per le quali non è stata accertata la menopausa e che desiderano proseguire l’HRT durante lo studio, dovranno utilizzare uno dei metodi di contraccezione altamente efficaci. In alternativa, prima dell’arruolamento nello studio, dovranno interrompere l’HRT per consentire la determinazione dell’eventuale stato di postmenopausa.
    4. In grado e disposti a fornire il proprio consenso informato.
    E.4Principal exclusion criteria
    1. eGFR calculated using MDRD formula <30mL/min/1.73m2 (based on the most recent documented serum creatinine laboratory assessment measured no more than 6 months prior to randomization. Local laboratory creatinine values taken as part of usual care are permitted.) or renal replacement therapy.
    2.Use of a GLP-1 receptor agonist at Screening.
    3.Severe gastroparesis requiring therapy within 6 months prior to Screening.
    4.History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones, excess alcohol use).
    5.Personal or family history of medullary carcinoma of the thyroid or subject with MEN-2. Personal history of pancreatic neuroendocrine tumours. In the opinion of the investigator, the subject has a medical history which might affect his / her ability to remain in the study for its entire duration, or which might limit management, such as life expectancy of <5 years (e.g. due to active malignancy).
    6.Subject has a medical history which in the opinion of the investigator might limit the individual’s ability to take trial treatments for the duration of the study or to otherwise complete the study.
    7.Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Pregnancy test will be required in women of child bearing potential. Women who have undergone a sterilisation procedure or who are clearly post-menopausal will not be required to undergo pregnancy testing. Women who have developed spontaneous secondary amenorrhoea of 12 months or more where post-menopausal status is in doubt, a blood sample where FSH >40MU/ml and oestrodiol <40 pg/mL (<140 pmol/L) are simultaneously measured will be considered confirmatory.
    8.Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
    9.Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
    10.Any other reason the investigator deems the subject to be unsuitable for the study.
    1. eGFR calcolata con formula MDRD <30 mL/min/1,73 m2 (sulla base delle più recenti valutazioni di laboratorio della creatinina sierica documentate non oltre i 6 mesi precedenti la randomizzazione. I valori di HbA1c di laboratorio locali misurati nel quadro del trattamento standard sono considerati validi) o terapia di sostituzione renale.
    2. Uso di un agonista del recettore del GLP-1 al momento dello screening.
    3. Gastroparesi grave che ha richiesto una terapia nei 6 mesi precedenti lo screening.
    4. Anamnesi di pancreatite, ovvero significativo rischio clinico di sviluppare pancreatite durante lo lo studio (ad es. a causa di calcoli biliari sintomatici, abuso di alcol).
    5. Anamnesi personale o familiare di carcinoma midollare della tiroide o neoplasia endocrina multipla di tipo 2. Anamnesi personale di tumori neuroendocrini del pancreas. Anamnesi medica del soggetto che secondo lo sperimentatore potrebbe influire sulla possibilità di rimanere nello studio per l’intera durata o potrebbe limitare il trattamento, ad esempio, per un’aspettativa di vita inferiore a 5 anni (ad es. a causa di una condizione maligna attiva).
    6. Anamnesi medica del soggetto che secondo lo sperimentatore potrebbe limitare la sua possibilità di assumere il trattamento sperimentale per l’intera durata dello studio oppure di completare lo studio.
    7. Soggetti di sesso femminile in gravidanza o che allattano al seno e donne che pianificano una gravidanza durante lo studio. Il test di gravidanza è necessario per le donne potenzialmente fertili. Le donne sottoposte a sterilizzazione chirurgica o in postmenopausa documentata non dovranno eseguire il test di gravidanza. Le donne che hanno sperimentato un’amenorrea spontanea secondaria per almeno 12 mesi e il cui stato di postmenopausa sia in dubbio, dovranno sottoporsi a un prelievo di conferma di campioni per la documentazione di un livello di FSH >40 mUI/mL e di estradiolo <40 pg/mL (<147 pmol/L).
    8. Allergie note a ogni agonista del recettore del GLP1, insulina o eccipienti di albiglutide.
    9. Uso di un altro prodotto sperimentale entro un intervallo di 30 giorni o 5 emivite (a seconda di quale dei due sia superiore) o ai sensi dei regolamenti locali o partecipazione a uno studio in corso su un dispositivo sperimentale.
    10. Qualsiasi altro motivo per cui lo sperimentatore ritenga che il soggetto sia inidoneo allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of MACE (cardiovascular death, myocardial infarction, or stroke) [Non-inferiority]
    Tempo alla prima occorrenza dei MACE (morte cardiovascolare, infarto miocardico o ictus) [non inferiorità]
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study will be event driven, i.e. follow up will continue until it is projected that approximately 611 adjudicated MACE events will have occurred. Consequently, the maximum duration of the study for an individual participant is dependent both on the time taken for recruitment and the MACE event rate, and is estimated to be between 3 and 5 years.
    Lo studio sarà di tipo event-driven (guidato dagli eventi), pertanto, proseguirà finché non si saranno verificati circa 611 eventi MACE validati. Di conseguenza, la durata massima dello studio per ogni singolo soggetto dipenderà sia dal tempo necessario per il reclutamento, sia dal tasso di eventi MACE, ed è stimata tra i 3 e i 5 anni.
    E.5.2Secondary end point(s)
    1. Time to first occurrence of MACE [Superiority]
    •Time to first occurrence of the following:
    -MACE or urgent revascularisation for unstable angina
    -The individual components of the primary endpoint
    -Cardiovascular death or hospitalization due to heart failure

    2. Time to initiation of insulin of more than 3 months duration for those subjects not treated with insulin at study start.
    •Time to initiation of prandial insulin in those subjects on basal insulin at study start
    •The proportion of subjects achieving glycaemic control (HbA1c ≤ 7.0% at final assessment) with no severe hypoglycaemic incidents and weight gain <5% of body weight.
    •The time to first occurrence of a clinically important microvascular event (see Section 6.2.4 of the protocol)
    •Change in HbA1c
    •Change in body weight
    •Patient reported outcomes from TRIM-D/EQ5D

    3.
    •All cause mortality
    •Non-fatal SAEs
    •AEs leading to discontinuation of investigational product
    •AE of special interest (see Section 6.2.3 of the protocol)
    •Change in eGFR calculated using Modification of Diet in Renal Disease (MDRD) formula
    •Change in blood pressure and heart rate
    E.5.2 End point secondario (ripetere se necessario):
    1. Tempo alla prima occorrenza dei MACE [superiorità]
    Tempo alla prima occorrenza di:
    - MACE o rivascolarizzazione urgente per angina instabile
    - Singoli componenti dell’endpoint primario
    - Morte cardiovascolare o ricovero ospedaliero per insufficienza cardiaca
    2. Tempo all’inizio della terapia insulinica di durata superiore a 3 mesi per i soggetti non trattati con insulina all’inizio dello studio
    • Tempo all’inizio della terapia con insulina prandiale nei soggetti in trattamento con la sola insulina basale all’inizio dello studio
    • Percentuale di soggetti che raggiunge il controllo glicemico (HbA1c ≤7,0% alla valutazione finale) senza presentare eventi ipoglicemici gravi e con un aumento ponderale <5%
    • Tempo alla prima occorrenza di un evento microvascolare clinicamente significativo (fare riferimento alla Sezione 6.2.4)
    • Modifica dei livelli di HbA1c
    • Variazione del peso corporeo
    • Outcome riportati dai pazienti dal questionario TRIM-D/EQD5
    3.
    • Mortalità per tutte le cause
    • Eventi avversi seri (SAE) non mortali
    • Eventi avversi che determinano la sospensione del farmaco in studio
    • Eventi avversi di speciale interesse (fare riferimento alla Sezione 6.2.3 del protocollo)
    • Variazione della eGFR calcolata con formula MDRD
    • Variazione della pressione arteriosa e della frequenza cardiaca
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study will be event driven, i.e. follow up will continue until it is projected that approximately 611 adjudicated MACE events will have occurred. Consequently, the maximum duration of the study for an individual participant is dependent both on the time taken for recruitment and the MACE event rate, and is estimated to be between 3 and 5 years.
    Lo studio sarà di tipo event-driven (guidato dagli eventi), pertanto, proseguirà finché non si saranno verificati circa 611 eventi MACE validati. Di conseguenza, la durata massima dello studio per ogni singolo soggetto dipenderà sia dal tempo necessario per il reclutamento, sia dal tasso di eventi MACE, ed è stimata tra i 3 e i 5 anni.
    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 Yes
    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 No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA312
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Norway
    Peru
    Philippines
    Poland
    Puerto Rico
    Russian Federation
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will be event driven, i.e. follow up will continue until it is projected that approximately 611 adjudicated MACE events will have occurred.

    Lo studio sarà di tipo event-driven (guidato dagli eventi), pertanto, proseguirà finché non si saranno verificati circa 611 eventi MACE validati.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 4700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4700
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4870
    F.4.2.2In the whole clinical trial 9400
    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)
    Subjects will be treated as deemed appropriate by the investigator following the end of the study. Investigational product will not be provided to subjects by GSK after the end of the study.
    Dopo la fine dello studio, i soggetti saranno trattati come ritenuto opportuno dal Medico dello studio. Dopo la fine dello studio, il farmaco non sarà fornito ai soggetti da GSK.
    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 Decision2015-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
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