| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Type 2 diabetes mellitus |
| Diabete Mellito di tipo 2 |
|
| E.1.1.1 | Medical condition in easily understood language |
| Type 2 diabetes mellitus |
| Diabete Mellito di tipo 2 |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10045242 |
| E.1.2 | Term | Type II diabetes mellitus |
| E.1.2 | System Organ Class | 100000004861 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1. To compare the addition of ertugliflozin with the addition of placebo on the change from baseline in hemoglobin A1C (A1C) at 24 weeks
2. To assess the safety and tolerability of ertugliflozin over 24 weeks and 54 weeks |
1. confrontare l'aggiunta di ertugliflozin con l'aggiunta di placebo nella variazione rispetto al basale dell’A1C a 24 settimane.
2. valutare la sicurezza e la tollerabilità di ertugliflozin nel corso di 24 settimane e di 54 settimane. |
|
| E.2.2 | Secondary objectives of the trial |
1. To compare the effect of the addition of ertugliflozin to the addition of placebo on the change from baseline in fasting plasma glucose (FPG) at 24 weeks
2. To assess the within-group (ertugliflozin and placebo) changes from baseline at 54 weeks for A1C and FPG |
1. confrontare l’effetto dell'aggiunta di ertugliflozin rispetto all'aggiunta di placebo nella variazione rispetto al basale della glicemia plasmatica a digiuno (FPG) a 24 settimane.
2. valutare le variazioni intra-gruppo (ertugliflozin e placebo) rispetto al basale a 54 settimane per A1C e FPG. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies
Specify title, date and version of each substudy with relative objectives: Merck will conduct Future Biomedical Research on DNA (Blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described
elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
|
Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Merck condurrà la Ricerca Biomedica Futura su campioni di DNA (sangue) raccolti durante questo studio clinico. Tale ricerca ha la scopo di testare biomarker per indagare su questioni emergenti
non descritte nel protocollo (come parte della prova principale) e verrà condotta solo su campioni provenienti da soggetti che hanno dato il loro consenso.
L'obiettivo della raccolta dei campioni per la Ricerca Biomedica Futura è quello di analizzare e identificare i biomarcatori che permettano di comprendere le malattie e/o i loro trattamenti terapeutici. L'obiettivo generale è quello di utilizzare tali informazioni per sviluppare farmaci più sicuri e più efficaci e/o per garantire che i soggetti ricevano la dose corretta del farmaco corretto al momento giusto.
|
|
| E.3 | Principal inclusion criteria |
| 1. Have T2DM as indicated by "yes" answers to all of the following: i. Participant has diabetes diagnosed by one of the following American Diabetes Association (ADA) criteria, eg: a) Laboratory determinations of FPG >=126 mg/dL (7.0 mmol/L), OR b) Random plasma glucose >=200 mg/dL (11.1 mmol/L), OR c) 2-hour oral glucose tolerance test (OGTT) plasma glucose >=200 mg/dL (11.1 mmol/L), OR d) A1C >=6.5% (48 mmol/mol) test performed using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications Trial (DCCT) Assay ii. Participant has BMI >=85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of T2DM 2. Have: i. T2DM for >=2 years, OR ii. T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening Visit/Visit 1 3. Be:i. On stable metformin monotherapy (>=1500 mg/day, for >=8 weeks prior to Screening Visit/Visit 1), OR ii. On a stable metformin dose (>=1500 mg/day, for >=8 weeks prior to Screening Visit/Visit 1) and a stable dose of insulin (of any type, variance in dose to be <=15% of total daily dose for >=8 weeks prior to Screening Visit/ Visit 1) 4. Have an A1C >=6.5% and <=10.0% (48 mmol/mol and 86 mmol/mol) at Screening Visit/Visit 1 if on metformin monotherapy, OR an A1C >=7.0% and <=10.0% (53 mmol/mol and 86 mmol/mol) at Screening Visit/Visit 1 if on metformin + insulin 5. Be male or female, >=10 years and <=17 years of age, when the informed consent is signed by the legally acceptable representative, and randomization (Visit 3/Week 0/Day 1) will occur prior to the participant's 18th birthday 6. Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 7. Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies 8. Be a female participant who is unlikely to conceive as indicated by at least 1 "yes" response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study treatment: i. Participant is a non-sterilized female who is currently not sexually active and agrees to follow statement "iii" if heterosexual activity is initiated, OR ii. Participant is a non-sterilized female who agrees to abstain from heterosexual activity iii. Participant is a non-sterilized female who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception 9. Have a legally acceptable representative who understands the study procedures,alternative treatments available and risks involved with the study, and voluntarily agrees to the child's participation by living informed written consent, and the participant has an age-appropriate understanding of the same by giving informed written assent. In addition, the legally acceptable representative may also consent to have the child participate in Future Biomedical Research (FBR) by signing a separate consent. Otherwise eligible participants will be able to participate in the main study even if they opt to not participate in FBR 10. Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures (ie, available for telephone calls, study visits and administration of study medication as needed) 11. Have >=80% compliance with placebo treatment during the single blind run-in as measured by site-performed tablet count |
1Essere affetto da DMT2 indicato da risposte “sì” a tutte le seguenti voci:
iAvere ricevuto una diagnosi di diabete basata su uno dei seguenti criteri AmericanDiabetesAssociation (ADA), ad esempio:
aDeterm lab della FPG>=126 mg/dl (7,0 mmol/l)OPP
bGlicemia plasmatica casuale>=200 mg/dl(11,1 mmol/l) OPP
c.Glicemia plasmatica da test orale di tolleranza al glucosio (OGTT)2 ore>=200 mg/dl(11,1 mmol/l)OPP
dlivelli di A1C >=6,5% (48 mmol/mol) misurati utilizzando un metodo certificato e standardizzato dal Programma di standardizzazione nazionale della glicoemoglobina (NGSP) per il saggio della Sperimentazione sul controllo e le complicazioni del diabete (DCCT).
ii.Presentare>=85° percentile dell’IMC allo screening OPPURE un’anamnesi di sovrappeso o obesità al momento della diagnosi di DMT2.
2Essere affetto da:
iDMT2 da>=2 anni,OPP
iiDMT2 da <2 anni e presentare un valore del peptide C a digiuno >0,6 ng/ml alla Visita di screening/Visita 1
3Deve ricevere:
iUna dose stabile di metformina in monoterapia (=1500 mg/die, per =8 settimane prima della Visita di screening/Visita 1), OPP
ii. Una dose stabile di metformina (>=1500 mg/die, per =8 settimane prima della Visita di screening/Visita 1) e una dose stabile di insulina (di qualsiasi tipo, la variazione della dose deve essere<=15% della dose giornaliera totale per>=8 sett prima della Visita di screening/Visita 1).
4Presentare un livello di A1C>=6,5% e =10,0% (48 mmol/mol e 86 mmol/mol) alla Visita di screening/Visita 1 se trattati con metformina in monoterapia OPP un A1C>=7,0%e<=10,0% (53 mmol/mol e 86 mmol/mol) alla Visita di screening/Visita 1 se trattati con metformina+insulina
5Essere sesso maschile o femminile,>=10 anni e<=17anni età al momento della firma del consenso informato da parte del rappresentante legale autorizzato e la randomizzazione (Visita 3/Settimana 0/Giorno 1) ha luogo prima del 18° compleanno del partecipante.
6Contraccettivi impiegati dai partecipanti di sesso masch devono essere in linea con le normative locali sui metodi di contraccez per partecipanti studi clinici
7Uso contraccettivi da parte delle partecipanti di sesso femminile deve essere in linea con le normative locali sui metodi di contraccezione per i partecipanti agli studi clinici.
8Essere partecipante sesso femm con possibilità di concepimento improbabile, come indicato da almeno 1 risposta "sì" alla voce seguente,deve restare invariata durata prevista dello studio e per 14 giorni dopo l'ultima dose del trattamento dello studio:
iPartec è donna non sterilizzata che attualmente non è sessualmente attiva e accetta di attenersi alla dichiarazione "iii" se avvia un’attività eterosessuale, OPP
iiPart è donna non sterilizzata che accetta di astenersi dai rapporti eterosessuali
iiiLa partecipante è una donna non sterilizzata che accetta di impiegare la contraccezione prima di iniziare l’attività sessuale e che accetta di utilizzare un metodo contraccettivo adeguato
9Avere rapprLegale che comprende procedure applicate nello studio clinico, i trattamenti alternativi disponibili e i rischi che lo studio comporta, e che volontariam acconsente alla partecipazione del minore firmando il consenso informato, e il partecipante ha comprensione (consona età) dello stu attr assenso scritto.
Inoltre,rapprLegale può fornire il consenso alla partecip minoreRicercheBiomedicheFuture(FBR)attr firma un distinto consenso
Soggpotranno partecipare allo studio principale anche se hanno sceltoNon partecipareFBR,purchè idonei secondo i criteri elencati
10AvereFamiliare o un adulto,seguendo sogg partecipante,è strett coinvolto attività giornaliere stesso(sec opinione investigatore) e nei trattamenti e le procedure studio previste per sogg(es è disponibile durante contatti telefonici,le visite e le somministrazioni farmaco).
11Hanno compliance>=80% per il tratt con placebo durante la fase a singolocieco “runin” come misurata dal conteggio delle compresse assunte nei centri. |
|
| E.4 | Principal exclusion criteria |
Screen Visit/Visit 1
1immed family member investigat site o Spons staff involved with this study
2known type1diab mellitus o evidence positive diab autoantibodies perfomed when particip was diagn with diab
3know monogenic diab,o sec diabetes
4symptom hyperglyc and/o moderate to large ketonuria requiring immed initiat of other antihyperglyc agent, includ insulin
5active, obstruct uropathy o urinary catheter
6hist malignancy<=5years prior signing inform cons, exc for adequ treated basal cell o squam cell skin cancer,o in situ cervical cancer
7know hypersensit o intoler to SGLT2inhib
8act liver disease(other than nonalcoholic hepatic steat)by hist, includ chronic act hepatitisBoC, primary biliary cirrhosis, o sympt gallbladder disease
9act nephrop o abnorm genitourinary tract that predisp to recurrent urinary tract infections
10any of follow crit:Particip on a weightloss program and not weight-stable,Part on weight-loss medic and isnot weightstable, Part on medicat associated with weight changes, Part had bariatric surgery any time past
11prev diagnos with disoders growth o bone metabolism
12clinic signif hemat disoder(aplastic anemia, thrombocyt, myeloprolif o myelodysplastic syndr)
13pregnant,breast feeding,expecting to conceive o don eggs during stud,includ14days following last dose of stu medicat
14treat with sulfonylurea,metiglinide,alpha glucosidase inhib,DPP4 inhib, o incretin-based agent in8weeks prior Screen Vis/Vis1
1treat with thiazolidinedione in16weeks prior ScreenVis/Vis1
16taking blood press medic and not on stable dose for at least4weeks prior randomiz
17current treat for hyperthyr
18on, o likely to require treatm with>=14 consec days o repeated courses of pharma doses of coticosteroids
19prev taken SGLT2 inhib(canagliflozin,dapagliflozin,empagliflozin,ertugliflozin)or enrolled in stud for these agents
20HasScreen Visit/Visit1 SBPoDBP>=95th percent for age, height perc gender and not consider likely to have values<95th perc age, height perc and gender byVis3/Week 0/Day1/Random even with appropr antihypertens ther
21fast serum triglyc>500mg/dL(5.65 mmol/L)ScreenVis/Vis1,confirm single repeat if deem neces
22eGFR<45 mL/min/1.73m2 ScreenVis/Vis1
23ASToALT>2.5X theULN atScreen Vis/ Vis1,tot bilirubin>1.5X the ULN unless particip has hist of Gilbert syndr
24hemoglobin levels below nomal range age and sex atScreen Vis/Vis1
25TSH levels outside nomal range atScreen Vis/ Vis1
26hist of idiopathic acute pancreatitis o chronic pancreatitis
27hist of sev hypoglyc while on insulin
28known hist of illicit drug use, or alcohol abuse or depend(within past year)
29donated blood prod or phlebotomy of >10% of estimated tot blood vol within8weeks of signing inform consent or intends donate blood prod or receive blood prod within projected durat of study
30unlikely adhere to study proced and appointment schedule,planning to relocate outside of geogr area dur study, or poor mental funct, or legally accept represent is in opinion of invest, incapacitated prevent inform cons from being obt
31his or current evid of cond, ther, lab abnormality or circumstance which, in opin of invest, might pose risk to partic, make partic not in part’s interest, might confound results of study, or interfere with part’s involvem for full durat of study
Visit2/Week1
32symptom hyperglyc o ketonuria
33clinic significECGabnorm that requires further diagnostic eval o interv which,opinion investig, exposes particip to risk by enrolling stud.prolong QTc interval fo age
34Requires initiation of concom medic sec6.5
Visit3/Week 0/Day 1/Random
35sympt hyperglyc,keton,requie immed change to antihyperglyc ther
36develop new med condit, suffered change in status establish med cond, developed lab abnorm requir new treatm o med during runin which meets prev described stud excl criter
37fem with pos pregnancy test
38FFSG>240 mg/dL(13.3 mmol/L)
39FFSG <130 mg/dL (7.2 mmol/L) if on insulin |
VisitScreen/Visit1
1È/HaParenteStrettoParteDiPersonCentro Sperim O DiPersonDiSponsor Coinv in qstStu
2pres Diab Mell1 O EvidAutoantic PosDiab
3Diab Monog O Diab Sec
4Iperglic Sintom E/O ChetonuriaModerAGrave Che Rich avvio Immed diAltro Ag Anti-Iperglic, Compr insu
5Uropat Ostr Att OPortatCatetere UrinAPerman
6Anamn Tum Malig<=5AnniPr Firma d Cons Inform, Ecc Per Carci a Cell Bas o Cutan a CellSquam Adeguat Tratt o Tum In SituCerv
7Ipersens /Intoll Inib SGLT2
8AnamnMalat Epat Att(DiversaDaSteat Epat Nn Alcol),Compr EpatBoC Cron Att,Cirr Bil Prima OMalatt Colec Sintom
9Nefropat Att(Sindr Nefros O Glomerulonefr)O Anom Trat Genitourin Che Predisp A Infez Ricor D Trat Urin
10Sodd Seg Crit,Partec SeguendoProgr Perd Peso E Nn Peso Stab,ass Farm Perd Peso(orlistat,fentermina/topiramato,Lorcaserina)E No Peso Stab,TrattAltriFarmAssocA CambPeso(Ag Antips) E NoPeso Stab,In Pass Sottop A Interv Chir Bariatrica
11diagn Prec Dist Cresc O Metab Osseo
12Dist Ematol Clin signif(AnemAplastica,Trombocit,SindMieloproliferativaOMielosplastica)
13 Incinta,allattaOPrevedeGravidODonareOvuliDurStu,Compresi14ggSucc ultimDoseFarmStu
14È Stato TrattSulfonilurea,Metiglinide,InibalfaGlucosidasi,InibDPP4
O Farm A Base Incretineo8Sett PrecedVisiScreen/Visit1
15TrattTiazolineone16SettPrecedVisitScreen/Visit1
16 Assumendo Farm Per La Pressione Sanguigna E Nn Ha Ricevuto A Dose Stabile Per Almeno 4 Sett Prima Randomizzazione
17ÈAttTratt PerIpert
18È Att Tratt oPotrebbeRichiedTratt>=14GgConsec O Cicli RipetutiDosi FarmlogicheCorticosteroi
19Ha Assto InibSGLT2(Canagliflozin,Dapagliflozin,Empagliflozin O Ertugliflozin)OArruolato In O Stu Per Qst Ag
20PresPAS oPressArteriosaAstolica(PAD)>=95°PercPer Età,PercaltezzaE Sesso VisitScreen/Visit1 E Nn Ritiene Probabile Ottenga Valori<95°PercEtà, Perc altezzaE SessoEntroVisit 3/Sett0/GG1/RandomTerap Antipertensiva Approp
21PresTrigliceri Sierici A Gg>500Mg/Dl(5,65Mmol/L)VisitScreen/Visit1,ConfermatiSe Ritenuto Necessario.Partec Livelli Elevati Trigliceri PossonoEssere Sottoposti A Nuovo Screen PreviaAutorizzaz Del Rettore Clinico Dello Sponsor Se PresnoLivelloTrigliceriNorm(<150Mg/Dl[1,7Mmol/L])DopoSeguito A Eta Per La RiduzDei Trigliceri O Regime Farmlogico Ipolipemizzante Stabile Almeno 4 Sett Prima Nuovo Screen Senza Ulteriori Mofiche Dose DurantPeriodoPreRandom
22PresVelocità FiltrazGlomerulareStimata(Egfr)Egfr<45 Ml/Min/1,73M2 Visit Screen/Visit 1
23Pres Livello AspartatoTransaminasi(AST)OAlaninaTransaminasi(ALT)>2,5VolteLimite Sup Norma(ULN) VisitScreen/Visit1OppBilirubinaTot>1,5 Volte uln,A Meno Che Il Partec Nn Presenti Anamnesi Sindr Gilbert.
24Pres Livelli EmoglInferiori intervalloNormale PerEtàESessoVisitScreen/Visit1
25PresLivelli OrmoneTireostimolante(TSH)AlFuoriIntervallNormaleVisitScreen/Visit1
26PresAnamnesiPancreatiteIopaticaAcutaoPancreatiteCronica
27PresAnamnesiIpoglicemiaGrave(IpoglicemiAssociataDeficitSensoriale,Crisi Convulsive O PerdCoscienza) Tratt Con Insu
28PresAnamnesi Nota Uso Droghe Ricreative O Illegali O Abuso O Pendenza Da Alcolici
29DonaProdotti Ematici O Ha Subito A Flebotomia>10%VolSangueTotStimato8Sett PrecedFirmaConsensoInfor IntendeDonareORicevere Prodotti Ematici EntroDurata PrevistaStu
30RichAvvioFarmConcomitantElencatiProtVisit3/Sett0/Gg1/Random
31PresIperglicemiaSintomE/OChetonuriaRichiedMofica Immeata Terap Antiperglicemica.
32SvilupNuovaCond Med,EvidenCambStatoCond Med Accertata,SvilupAnomaliaLab O Necessita Nuovo Tratt O Farm Durante Il R-In Che Sodd O Dei Criteri Esclus Dallo Stu Preced Descritti
33donna Test Gravid Pos
34PresGlicemia Gio Rilevata Attr Ptura Polpastrello(FFSG)>240mg/Dl (13,3 Mmol/L)
35presffsg<130 Mg/Dl(7,2 Mmol/L)Insu
36Ha svilup nuova condiz medica, cambiam stato di condiz medica accertata,svilup anomalia lab o necessita nuovo trattam o farmaco durante runin che soddisfa uno criteri esclusione stu
37È donna test gravid+
38Glicemia digiuno rilevataAttr puntura polpastrello(FFSG)>240mg/dl(13,3mmol/l)
39FFSG<130mg/dl(7,2mmol/l)se assume insu |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Change from Baseline in A1C at 24 weeks
2. Number of Participants Who Experience an Adverse Event (AE)
3. Number of Participants Who Experience an AE
4. Number of Participants Who Discontinue Study Treatment Due to an AE
5. Number of Participants Who Discontinue Study Treatment Due to an AE |
1. Cambiamento dal basale in A1C a 24 settimane
2. Numero di partecipanti che sperimentano un evento avverso (AE)
3. Numero di partecipanti che hanno esperienza di AE
4. Numero di partecipanti che interrompono il trattamento dello studio a causa di un EA
5. Numero di partecipanti che interrompono il trattamento dello studio a causa di un EA |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Baseline and 24 weeks
2. Up to 24 weeks
3. Up to 54 weeks
4. Up to 24 weeks
5. Up to 54 weeks |
1. Linea basale e 24 settimane
2. Fino a 24 settimane
3. Fino a 54 settimane
4. Fino a 24 settimane
5. Fino a 54 settimane |
|
| E.5.2 | Secondary end point(s) |
1. Change from Baseline in FPG at 24 weeks
2. Change from Baseline in A1C at 54 weeks
3. Change from Baseline in FPG at 54 weeks |
1. Cambiamento da baseline in FPG a 24 settimane
2. Cambiamento dal basale in A1C a 54 settimane
3. Cambiamento dal basale in FPG a 54 settimane |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Baseline and 24 weeks
2. Baseline and 54 weeks
3. Baseline and 54 weeks |
1. linea di base e 24 settimane
2. linea di base e 54 settimane
3. linea di base e 54 settimane |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 19 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Canada |
| Colombia |
| Costa Rica |
| Dominican Republic |
| Guatemala |
| Israel |
| Malaysia |
| Mauritius |
| Mexico |
| Philippines |
| Russian Federation |
| Saudi Arabia |
| Turkey |
| Ukraine |
| United Arab Emirates |
| United States |
| Belgium |
| France |
| Hungary |
| Italy |
| Poland |
| United Kingdom |
|
| E.8.7 | Trial 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
|
| End of study will be declared after (1) all participants in the study have completed Week 54 or have discontinued from study prior to Week 54, (2) the database has been locked (after medical and scientific reviews of the data have been completed), and (3) the data have been unblinded. |
| La fine dello studio sarà dichiarata dopo (1) tutti i partecipanti allo studio hanno completato la settimana 54 o hanno interrotto lo studio prima della settimana 54, (2) il database è stato bloccato (dopo che le analisi mediche e scientifiche dei dati sono state completate) e (3) i dati sono stati sbloccati. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 6 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 6 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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