Evaluering af kardiovaskulære resultater hos patienter med type 2-diabetes efter akut koronarsyndrom under behandling med AVE0010 (Lixisenatid) (ELIXA)
31. oktober 2016 opdateret af: Sanofi
En randomiseret, dobbeltblind, placebokontrolleret, parallelgruppe, multicenterundersøgelse til evaluering af kardiovaskulære resultater under behandling med Lixisenatid hos type 2-diabetespatienter efter et akut koronarsyndrom
Primært mål:
- At demonstrere, at lixisenatid kan reducere kardiovaskulær (CV) morbiditet og dødelighed (sammensat endepunkt af CV død, ikke-dødelig myokardieinfarkt (MI), ikke-dødelig slagtilfælde, hospitalsindlæggelse for ustabil angina) sammenlignet med placebo hos type 2 diabetiske deltagere, som for nylig oplevet en akut koronar syndrom (ACS) hændelse.
Sekundære mål:
For at demonstrere, at sammenlignet med placebo kan lixisenatid reducere:
- sammensat endepunkt af CV-død, ikke-dødelig MI, ikke-dødelig slagtilfælde, hospitalsindlæggelse for ustabil angina eller hospitalsindlæggelse for hjertesvigt.
- sammensat endepunkt af CV-død, ikke-dødelig MI, ikke-dødelig slagtilfælde, hospitalsindlæggelse for ustabil angina, hospitalsindlæggelse for hjertesvigt eller koronar revaskulariseringsprocedure.
- albuminudskillelse i urin (baseret på urinalbumin/kreatinin-forholdet).
For at vurdere sikkerheden og tolerabiliteten af lixisenatid.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Den estimerede maksimale undersøgelsesvarighed for den første randomiserede deltager var ca. 204 uger (± 14 dage), med en medianopfølgning over alle deltagere på ca. 91 uger, opdelt som følger:
- placebo-indkøringsperiode: 7 dage (+ 3 dage)
- dobbeltblind undersøgelsesbehandlingsperiode: 203 uger (± 14 dage) (med ca. 37 måneders rekrutteringsperiode)
- opfølgningsperiode efter behandling: 3 dage (± 1 dag)
Alle deltagere blev fulgt fra randomisering til slutningen af undersøgelsen, hvilket skulle ske, når den sidste randomiserede deltager var blevet fulgt i cirka 10 måneder. Den faktiske slutdato for undersøgelsen var "hændelsesdrevet", og undersøgelsens afslutning, da der var ca. 844 positivt bedømte primære kardiovaskulære udfaldsbegivenheder.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6068
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Adrogue, Argentina, B1846DSK
- Investigational Site Number 032028
-
Bahia Blanca, Argentina, B8000AKK
- Investigational Site Number 032030
-
Bahia Blanca, Argentina, B8000FTD
- Investigational Site Number 032043
-
Bahia Blanca, Argentina, B8001HXM
- Investigational Site Number 032054
-
Caba, Argentina, 1120
- Investigational Site Number 032066
-
Caba, Argentina, 1440
- Investigational Site Number 032049
-
Caba, Argentina, C1181ACL
- Investigational Site Number 032056
-
Caba, Argentina, C1425AGC
- Investigational Site Number 032003
-
Capital Federal, Argentina, C1056ABJ
- Investigational Site Number 032017
-
Capital Federal, Argentina, C1179AAB
- Investigational Site Number 032009
-
Cipolletti, Argentina, 8324
- Investigational Site Number 032050
-
Ciudad Autonoma De Bs.As, Argentina, 1428
- Investigational Site Number 032052
-
Cordoba, Argentina, X50009BSN
- Investigational Site Number 032011
-
Cordoba, Argentina, X5000AAW
- Investigational Site Number 032022
-
Cordoba, Argentina, X5000AAX
- Investigational Site Number 032037
-
Coronel Suarez, Argentina, B7540GHD
- Investigational Site Number 032020
-
Corrientes, Argentina, 3400
- Investigational Site Number 032004
-
Corrientes, Argentina, W3410AVV
- Investigational Site Number 032018
-
Córdoba, Argentina, 5000
- Investigational Site Number 032015
-
Godoy Cruz, Argentina, M5501ARP
- Investigational Site Number 032005
-
Haedo, Argentina, 1706
- Investigational Site Number 032042
-
Junin, Argentina, B6000BHA
- Investigational Site Number 032019
-
La Plata, Argentina, 1900
- Investigational Site Number 032063
-
Lanus, Argentina, 1824
- Investigational Site Number 032040
-
Mar Del Plata, Argentina, B7600
- Investigational Site Number 032036
-
Mar Del Plata, Argentina, C7600CBM
- Investigational Site Number 032039
-
Mendoza, Argentina, 5500
- Investigational Site Number 032058
-
Moron, Argentina, 1708
- Investigational Site Number 032038
-
Parana, Argentina, E3100BBJ
- Investigational Site Number 032002
-
Qilmes, Argentina, b1878dkf
- Investigational Site Number 032023
-
Rafaela, Argentina, S2300MMA
- Investigational Site Number 032047
-
Ramos Mejia, Argentina, 1704
- Investigational Site Number 032024
-
Resistencia, Argentina, H3500CDM
- Investigational Site Number 032006
-
Rosario, Argentina, 2000CVD
- Investigational Site Number 032012
-
Rosario, Argentina, S2000DSR
- Investigational Site Number 032027
-
Salta, Argentina, 4400
- Investigational Site Number 032055
-
Salta, Argentina, 4400
- Investigational Site Number 032065
-
San Miguel De Tucuman, Argentina, 4000
- Investigational Site Number 032051
-
San Miguel De Tucuman, Argentina, T4000ICL
- Investigational Site Number 032008
-
San Nicolas, Argentina, B2900DMH
- Investigational Site Number 032033
-
Santa Fe, Argentina, S3000AZG
- Investigational Site Number 032045
-
Santa Fe, Argentina, S3000FWO
- Investigational Site Number 032035
-
Santa Rosa, Argentina, L6300DSD
- Investigational Site Number 032062
-
Venado Tuerto, Argentina, S2600KUE
- Investigational Site Number 032034
-
Villa Maria, Argentina, X5900JKA
- Investigational Site Number 032046
-
Zarate, Argentina, B2800DGH
- Investigational Site Number 032029
-
-
-
-
-
Epping, Australien, 3076
- Investigational Site Number 036015
-
Fremantle, Australien, 6160
- Investigational Site Number 036001
-
Geelong, Australien, 3220
- Investigational Site Number 036009
-
Perth, Australien, 6000
- Investigational Site Number 036011
-
St Leonards, Australien, 2065
- Investigational Site Number 036005
-
Townsville, Australien, 4810
- Investigational Site Number 036016
-
-
-
-
-
Bruxelles, Belgien, 1200
- Investigational Site Number 056001
-
Leuven, Belgien, 3000
- Investigational Site Number 056003
-
-
-
-
-
Belem, Brasilien, 66087-660
- Investigational Site Number 076024
-
Belo Horizonte, Brasilien, 30150-221
- Investigational Site Number 076006
-
Belo Horizonte, Brasilien, 30150-221
- Investigational Site Number 076012
-
Brasilia, Brasilien, 70310-500
- Investigational Site Number 076021
-
Campinas, Brasilien, 13015-001
- Investigational Site Number 076002
-
Curitiba, Brasilien, 80730-150
- Investigational Site Number 076019
-
Fortaleza, Brasilien, 60430-370
- Investigational Site Number 076004
-
Fortaleza, Brasilien, 60115-282
- Investigational Site Number 076003
-
Fortaleza, Brasilien, 60170-320
- Investigational Site Number 076018
-
Goiania, Brasilien, 74823470
- Investigational Site Number 076023
-
Marilia, Brasilien, 17515-240
- Investigational Site Number 076014
-
Passo Fundo, Brasilien, 99010-180
- Investigational Site Number 076015
-
Porto Alegre, Brasilien, 90020-090
- Investigational Site Number 076008
-
Porto Alegre, Brasilien, 90035-001
- Investigational Site Number 076013
-
Porto Alegre, Brasilien, 90620-001
- Investigational Site Number 076026
-
Recife, Brasilien, 52051-380
- Investigational Site Number 076025
-
Salvador, Brasilien, 40050-410
- Investigational Site Number 076020
-
Sao Paulo, Brasilien, 01323-001
- Investigational Site Number 076016
-
Sao Paulo, Brasilien, 04012-180
- Investigational Site Number 076010
-
Sao Paulo, Brasilien, 04024-002
- Investigational Site Number 076001
-
Sao Paulo, Brasilien, 05403-000
- Investigational Site Number 076005
-
Uberlandia, Brasilien, 38400-368
- Investigational Site Number 076007
-
-
-
-
-
Byala, Bulgarien, 7100
- Investigational Site Number 100002
-
Gabrovo, Bulgarien, 5300
- Investigational Site Number 100011
-
Kazanluk, Bulgarien, 6100
- Investigational Site Number 100001
-
Lovech, Bulgarien, 5500
- Investigational Site Number 100006
-
Pleven, Bulgarien, 5800
- Investigational Site Number 100004
-
Plovdiv, Bulgarien, 4002
- Investigational Site Number 100003
-
Plovdiv, Bulgarien, 4002
- Investigational Site Number 100007
-
Sandanski, Bulgarien, 2800
- Investigational Site Number 100016
-
Sofia, Bulgarien, 1606
- Investigational Site Number 100010
-
Sofia, Bulgarien, 1618
- Investigational Site Number 100015
-
Varna, Bulgarien, 9000
- Investigational Site Number 100005
-
-
-
-
-
Calgary, Canada, T2N 4N1
- Investigational Site Number 124024
-
Cambridge, Canada, N1R 7Z6
- Investigational Site Number 124016
-
Edmonton, Canada, T6G 2B7
- Investigational Site Number 124026
-
Laval, Canada, H7T 2P5
- Investigational Site Number 124001
-
Montreal, Canada, H1T 1C8
- Investigational Site Number 124021
-
Montreal, Canada, H3Z 1E5
- Investigational Site Number 124006
-
Oshawa, Canada, L1J 2J9
- Investigational Site Number 124027
-
Quebec, Canada, G1V 4G5
- Investigational Site Number 124025
-
Red Deer, Canada, T4N 6V7
- Investigational Site Number 124028
-
Sarnia, Canada, N7T 4R9
- Investigational Site Number 124007
-
St-Marc-Des-Carrieres, Canada, G0A 4B0
- Investigational Site Number 124003
-
Sudbury, Canada, P3C 5K7
- Investigational Site Number 124005
-
Thetford Mines, Canada, G6G 2V4
- Investigational Site Number 124002
-
-
-
-
-
Antofagasta, Chile, 1270001
- Investigational Site Number 152024
-
Concepcion, Chile, 4070038
- Investigational Site Number 152023
-
Osorno, Chile, 5311092
- Investigational Site Number 152041
-
Puerto Montt, Chile, 5480000
- Investigational Site Number 152040
-
Punta Arenas, Chile, 6210005
- Investigational Site Number 152038
-
San Felipe, Chile, 2172972
- Investigational Site Number 152036
-
Santiago, Chile, 7500710
- Investigational Site Number 152001
-
Santiago, Chile, 7650018
- Investigational Site Number 152019
-
Santiago, Chile, 285-1950
- Investigational Site Number 152035
-
Santiago, Chile, 7500010
- Investigational Site Number 152020
-
Santiago, Chile, 7500503
- Investigational Site Number 152028
-
Santiago, Chile, 7500520
- Investigational Site Number 152031
-
Santiago, Chile, 7500710
- Investigational Site Number 152034
-
Santiago, Chile, 7591047
- Investigational Site Number 152008
-
Santiago, Chile, 7591047
- Investigational Site Number 152013
-
Santiago, Chile, 7980378
- Investigational Site Number 152018
-
Santiago, Chile, 80004005
- Investigational Site Number 152042
-
Santiago, Chile, 8053095
- Investigational Site Number 152015
-
Santiago, Chile, 8350595
- Investigational Site Number 152004
-
Santiago, Chile, 838-0456
- Investigational Site Number 152029
-
Santiago, Chile, 8380456
- Investigational Site Number 152022
-
Santiago, Chile, 890-0085
- Investigational Site Number 152011
-
Talca, Chile, 9999
- Investigational Site Number 152025
-
Temuco, Chile, 4813299
- Investigational Site Number 152003
-
Temuco, Chile, 4781173
- Investigational Site Number 152014
-
Valdivia, Chile, 5090146
- Investigational Site Number 152037
-
Valparaíso, Chile, 234-0207
- Investigational Site Number 152032
-
Vina Del Mar, Chile
- Investigational Site Number 152002
-
Viña Del Mar, Chile, 2570017
- Investigational Site Number 152010
-
-
-
-
-
Armenia, Colombia
- Investigational Site Number 170025
-
Barranquilla, Colombia
- Investigational Site Number 170009
-
Barranquilla, Colombia
- Investigational Site Number 170010
-
Bogota, Colombia
- Investigational Site Number 170012
-
Bogota, Colombia
- Investigational Site Number 170005
-
Bogota, Colombia
- Investigational Site Number 170002
-
Bogota, Colombia
- Investigational Site Number 170014
-
Bogota, Colombia
- Investigational Site Number 170022
-
Bucaramanga, Colombia
- Investigational Site Number 170004
-
Cali, Colombia
- Investigational Site Number 170017
-
Cali, Colombia
- Investigational Site Number 170024
-
Cartagena, Colombia
- Investigational Site Number 170013
-
Espinal - Tolima, Colombia
- Investigational Site Number 170026
-
Floridablanca, Colombia
- Investigational Site Number 170007
-
Floridablanca, Colombia
- Investigational Site Number 170008
-
Manizales, Colombia
- Investigational Site Number 170019
-
Medellin, Colombia
- Investigational Site Number 170003
-
Medellin, Colombia
- Investigational Site Number 170020
-
Pereira, Colombia
- Investigational Site Number 170021
-
-
-
-
-
Aarhus, Danmark, 8000
- Investigational Site Number 208003
-
Aarhus C, Danmark, 8000
- Investigational Site Number 208009
-
Esbjerg, Danmark, 6700
- Investigational Site Number 208011
-
Farsø, Danmark, 9640
- Investigational Site Number 208004
-
Hellerup, Danmark, 2900
- Investigational Site Number 208002
-
Herlev, Danmark, 2730
- Investigational Site Number 208010
-
Hillerød, Danmark, 3400
- Investigational Site Number 208008
-
Hvidovre, Danmark, 2650
- Investigational Site Number 208006
-
København Nv, Danmark, 2400
- Investigational Site Number 208001
-
København S, Danmark, 2300
- Investigational Site Number 208005
-
København Ø, Danmark, 2100
- Investigational Site Number 208007
-
-
-
-
-
Barnaul, Den Russiske Føderation, 656055
- Investigational Site Number 643023
-
Kazan, Den Russiske Føderation, 420012
- Investigational Site Number 643044
-
Kemerovo, Den Russiske Føderation, 650002
- Investigational Site Number 643005
-
Kemerovo, Den Russiske Føderation, 650002
- Investigational Site Number 643006
-
Krasnodar, Den Russiske Føderation, 350063
- Investigational Site Number 643061
-
Krasnodar, Den Russiske Føderation, 350086
- Investigational Site Number 643027
-
Moscow, Den Russiske Føderation, 101990
- Investigational Site Number 643037
-
Moscow, Den Russiske Føderation, 101990
- Investigational Site Number 643038
-
Moscow, Den Russiske Føderation, 105066
- Investigational Site Number 643002
-
Moscow, Den Russiske Føderation, 117036
- Investigational Site Number 643043
-
Moscow, Den Russiske Føderation, 117292
- Investigational Site Number 643008
-
Moscow, Den Russiske Føderation, 117292
- Investigational Site Number 643009
-
Moscow, Den Russiske Føderation, 117556
- Investigational Site Number 643029
-
Moscow, Den Russiske Føderation, 119048
- Investigational Site Number 643018
-
Moscow, Den Russiske Føderation, 119435
- Investigational Site Number 643042
-
Moscow, Den Russiske Føderation, 121309
- Investigational Site Number 643052
-
Moscow, Den Russiske Føderation, 121374
- Investigational Site Number 643026
-
Moscow, Den Russiske Føderation, 121552
- Investigational Site Number 643003
-
Moscow, Den Russiske Føderation, 125284
- Investigational Site Number 643051
-
Moscow, Den Russiske Føderation, 127018
- Investigational Site Number 643013
-
Moscow, Den Russiske Føderation, 127473
- Investigational Site Number 643001
-
Moscow, Den Russiske Føderation, 127644
- Investigational Site Number 643060
-
Moscow, Den Russiske Føderation, 129327
- Investigational Site Number 643040
-
Nizhny Novgorod, Den Russiske Føderation, 603003
- Investigational Site Number 643034
-
Novosibirsk, Den Russiske Føderation, 630047
- Investigational Site Number 643054
-
Novosibirsk, Den Russiske Føderation, 630075
- Investigational Site Number 643055
-
Omsk, Den Russiske Føderation, 644043
- Investigational Site Number 643045
-
Penza, Den Russiske Føderation, 440026
- Investigational Site Number 643030
-
Perm, Den Russiske Føderation, 614077
- Investigational Site Number 643017
-
Perm, Den Russiske Føderation, 614097
- Investigational Site Number 643049
-
Rostov-Na-Donu, Den Russiske Føderation, 344068
- Investigational Site Number 643048
-
Ryazan, Den Russiske Føderation, 390026
- Investigational Site Number 643047
-
Saint-Petersburg, Den Russiske Føderation, 194156
- Investigational Site Number 643039
-
Saratov, Den Russiske Føderation, 410028
- Investigational Site Number 643025
-
Saratov, Den Russiske Føderation, 410028
- Investigational Site Number 643056
-
Saratov, Den Russiske Føderation, 410030
- Investigational Site Number 643010
-
Saratov, Den Russiske Føderation, 410039
- Investigational Site Number 643033
-
Saratov, Den Russiske Føderation, 410054
- Investigational Site Number 643019
-
Smolensk, Den Russiske Føderation, 214018
- Investigational Site Number 643014
-
St-Petersburg, Den Russiske Føderation, 190000
- Investigational Site Number 643024
-
St-Petersburg, Den Russiske Føderation, 192242
- Investigational Site Number 643031
-
St-Petersburg, Den Russiske Føderation, 193312
- Investigational Site Number 643035
-
St-Petersburg, Den Russiske Føderation, 194044
- Investigational Site Number 643022
-
St-Petersburg, Den Russiske Føderation, 194354
- Investigational Site Number 643057
-
St-Petersburg, Den Russiske Føderation, 195257
- Investigational Site Number 643041
-
St-Petersburg, Den Russiske Føderation, 197341
- Investigational Site Number 643036
-
St-Petersburg, Den Russiske Føderation, 198013
- Investigational Site Number 643011
-
St-Petersburg, Den Russiske Føderation, 199106
- Investigational Site Number 643004
-
Tomsk, Den Russiske Føderation, 634012
- Investigational Site Number 643028
-
Tver, Den Russiske Føderation, 170036
- Investigational Site Number 643016
-
Tyumen, Den Russiske Føderation, 625023
- Investigational Site Number 643012
-
Vladimir, Den Russiske Føderation, 600020
- Investigational Site Number 643059
-
Voronezh, Den Russiske Føderation, 394065
- Investigational Site Number 643058
-
Yaroslavl, Den Russiske Føderation, 150003
- Investigational Site Number 643020
-
Yaroslavl, Den Russiske Føderation, 150030
- Investigational Site Number 643062
-
-
-
-
-
Antrim, Det Forenede Kongerige, BT41 2RL
- Investigational Site Number 826042
-
Ashton-Under-Lyne, Det Forenede Kongerige, OL6 9RW
- Investigational Site Number 826002
-
Barnstaple, Det Forenede Kongerige, EX31 4JB
- Investigational Site Number 826026
-
Bath, Det Forenede Kongerige, BA1 3NG
- Investigational Site Number 826017
-
Birmingham, Det Forenede Kongerige, B9 5SS
- Investigational Site Number 826034
-
Bolton, Det Forenede Kongerige, BL1 4AL
- Investigational Site Number 826052
-
Bradford, Det Forenede Kongerige, BD5 0NA
- Investigational Site Number 826005
-
Carmarthen, Det Forenede Kongerige, SA31 2AF
- Investigational Site Number 826048
-
Chester, Det Forenede Kongerige, CH2 1UL
- Investigational Site Number 826037
-
Dumfries, Det Forenede Kongerige, DG1 4AP
- Investigational Site Number 826011
-
East Kilbride, Det Forenede Kongerige, G75 8RG
- Investigational Site Number 826044
-
Edinburgh, Det Forenede Kongerige, EH3 9YW
- Investigational Site Number 826023
-
Glasgow, Det Forenede Kongerige, G11 6NT
- Investigational Site Number 826008
-
Harrogate, Det Forenede Kongerige, HG2 7SX
- Investigational Site Number 826010
-
Ipswich, Det Forenede Kongerige, IP4 5PD
- Investigational Site Number 826040
-
Larbert, Det Forenede Kongerige, FK5 4WR
- Investigational Site Number 826033
-
Liverpool, Det Forenede Kongerige, L9 7AL
- Investigational Site Number 826027
-
Londonderry, Det Forenede Kongerige, BT47 6SB
- Investigational Site Number 826039
-
Manchester, Det Forenede Kongerige, M13 9WL
- Investigational Site Number 826036
-
Manchester, Det Forenede Kongerige, M23 9LT
- Investigational Site Number 826021
-
Manchester, Det Forenede Kongerige, M8 6RB
- Investigational Site Number 826006
-
Norwich, Det Forenede Kongerige, NR1 3SR
- Investigational Site Number 826049
-
Nuneaton, Det Forenede Kongerige, CV10 7DJ
- Investigational Site Number 826020
-
Oldham, Det Forenede Kongerige, OL1 2JH
- Investigational Site Number 826009
-
Salford, Det Forenede Kongerige, M6 8HD
- Investigational Site Number 826007
-
Stoke-On-Trent, Det Forenede Kongerige, ST4 6QG
- Investigational Site Number 826045
-
Swansea, Det Forenede Kongerige, SA6 6NL
- Investigational Site Number 826038
-
Taunton, Det Forenede Kongerige, TA1 5DA
- Investigational Site Number 826018
-
Truro, Det Forenede Kongerige, TR1 3LJ
- Investigational Site Number 826016
-
Wolverhampton, Det Forenede Kongerige, WV10 0QP
- Investigational Site Number 826046
-
Yeovil, Det Forenede Kongerige, BA21 4AT
- Investigational Site Number 826019
-
-
-
-
-
Guayaquil, Ecuador, EC090112
- Investigational Site Number 218001
-
Guayaquil, Ecuador, EC09112
- Investigational Site Number 218005
-
Quito, Ecuador, EC090112
- Investigational Site Number 218002
-
-
-
-
-
Alexandria, Egypten
- Investigational Site Number 818002
-
Cairo, Egypten
- Investigational Site Number 818001
-
-
-
-
-
Tallinn, Estland, 13419
- Investigational Site Number 233001
-
Tallinn, Estland, 10138
- Investigational Site Number 233004
-
Tallinn, Estland, 13419
- Investigational Site Number 233003
-
Tallinn, Estland, 13415
- Investigational Site Number 233002
-
Tartu, Estland, 50406
- Investigational Site Number 233005
-
Viljandimaa, Estland, 71024
- Investigational Site Number 233006
-
-
-
-
-
Cavite, Filippinerne
- Investigational Site Number 608006
-
Iligan City, Lanao Del Norte, Filippinerne, 9200
- Investigational Site Number 608009
-
Makati City, Filippinerne
- Investigational Site Number 608003
-
Manila, Filippinerne, 1008
- Investigational Site Number 608001
-
Manila, Filippinerne
- Investigational Site Number 608007
-
Marikina City, Filippinerne, 1800
- Investigational Site Number 608005
-
Pasay City, Filippinerne, 1300
- Investigational Site Number 608002
-
Quezon City, Filippinerne, 1109
- Investigational Site Number 608008
-
-
-
-
-
Jyväskylä, Finland, 40620
- Investigational Site Number 246005
-
Rauma, Finland, 26100
- Investigational Site Number 246003
-
Tampere, Finland, 33520
- Investigational Site Number 246010
-
Turku, Finland, FIN-20520
- Investigational Site Number 246009
-
Valkeakoski, Finland, 37600
- Investigational Site Number 246007
-
Vantaa, Finland, 01600
- Investigational Site Number 246012
-
-
-
-
-
Abu Dhabi, Forenede Arabiske Emirater, 51900
- Investigational Site Number 784001
-
Dubai, Forenede Arabiske Emirater, 4545
- Investigational Site Number 784002
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35203
- Investigational Site Number 840415
-
Foley, Alabama, Forenede Stater, 36535
- Investigational Site Number 840307
-
Mobile, Alabama, Forenede Stater, 36604
- Investigational Site Number 840692
-
Mobile, Alabama, Forenede Stater, 36608
- Investigational Site Number 840037
-
Mobile, Alabama, Forenede Stater, 36609
- Investigational Site Number 840210
-
Muscle Shoals, Alabama, Forenede Stater, 35661
- Investigational Site Number 840326
-
Toney, Alabama, Forenede Stater, 35773
- Investigational Site Number 840393
-
-
Arizona
-
Mesa, Arizona, Forenede Stater, 85206
- Investigational Site Number 840656
-
Phoenix, Arizona, Forenede Stater, 85012
- Investigational Site Number 840506
-
Phoenix, Arizona, Forenede Stater, 85020
- Investigational Site Number 840520
-
Phoenix, Arizona, Forenede Stater, 85032
- Investigational Site Number 840322
-
Tempe, Arizona, Forenede Stater, 85284
- Investigational Site Number 840250
-
Tucson, Arizona, Forenede Stater, 85723
- Investigational Site Number 840042
-
-
Arkansas
-
Hot Springs, Arkansas, Forenede Stater, 71913
- Investigational Site Number 840303
-
Jonesboro, Arkansas, Forenede Stater, 72401
- Investigational Site Number 840184
-
Little Rock, Arkansas, Forenede Stater, 72204
- Investigational Site Number 840361
-
Little Rock, Arkansas, Forenede Stater, 72205
- Investigational Site Number 840023
-
-
California
-
Anaheim, California, Forenede Stater, 92801
- Investigational Site Number 840706
-
Anaheim, California, Forenede Stater, 92804
- Investigational Site Number 840497
-
Downey, California, Forenede Stater, 90242
- Investigational Site Number 840667
-
Fresno, California, Forenede Stater, 93722
- Investigational Site Number 840150
-
Hawthorne, California, Forenede Stater, 90250
- Investigational Site Number 840624
-
Inglewood, California, Forenede Stater, 90301
- Investigational Site Number 840623
-
Inglewood, California, Forenede Stater, 90301
- Investigational Site Number 840636
-
La Mesa, California, Forenede Stater, 91942
- Investigational Site Number 840455
-
Loma Linda, California, Forenede Stater, 92354
- Investigational Site Number 840240
-
Long Beach, California, Forenede Stater, 90806
- Investigational Site Number 840262
-
Long Beach, California, Forenede Stater, 90813
- Investigational Site Number 840606
-
Los Angeles, California, Forenede Stater, 90024
- Investigational Site Number 840694
-
Los Angeles, California, Forenede Stater, 90033
- Investigational Site Number 840431
-
Los Angeles, California, Forenede Stater, 90073
- Investigational Site Number 840135
-
Merced, California, Forenede Stater, 95348
- Investigational Site Number 840314
-
Mission Viejo, California, Forenede Stater, 92691
- Investigational Site Number 840290
-
National City, California, Forenede Stater, 91950
- Investigational Site Number 840592
-
Northridge, California, Forenede Stater, 91328
- Investigational Site Number 840275
-
Oakland, California, Forenede Stater, 94609
- Investigational Site Number 840654
-
Orange, California, Forenede Stater, 92868
- Investigational Site Number 840351
-
Orange, California, Forenede Stater, 92868
- Investigational Site Number 840689
-
Pomona, California, Forenede Stater, 91767
- Investigational Site Number 840582
-
Port Hueneme, California, Forenede Stater, 93041
- Investigational Site Number 840346
-
Roseville, California, Forenede Stater, 95661
- Investigational Site Number 840466
-
San Marino, California, Forenede Stater, 91108
- Investigational Site Number 840575
-
Santa Ana, California, Forenede Stater, 82705
- Investigational Site Number 840131
-
Santa Ana, California, Forenede Stater, 92704
- Investigational Site Number 840335
-
Simi Valley, California, Forenede Stater, 93065
- Investigational Site Number 840576
-
Sylmar, California, Forenede Stater, 91342
- Investigational Site Number 840414
-
Ventura, California, Forenede Stater, 93003
- Investigational Site Number 840395
-
Vista, California, Forenede Stater, 92081-7832
- Investigational Site Number 840206
-
Westlake Village, California, Forenede Stater, 91361
- Investigational Site Number 840480
-
Whittier, California, Forenede Stater, 90602
- Investigational Site Number 840350
-
-
Colorado
-
Colorado Springs, Colorado, Forenede Stater, 80910
- Investigational Site Number 840093
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20060
- Investigational Site Number 840631
-
Washington, District of Columbia, Forenede Stater, 20422
- Investigational Site Number 840044
-
-
Florida
-
Clearwater, Florida, Forenede Stater, 33755
- Investigational Site Number 840281
-
Homosassa, Florida, Forenede Stater, 34448
- Investigational Site Number 840477
-
Miami, Florida, Forenede Stater, 33135
- Investigational Site Number 840261
-
Miami, Florida, Forenede Stater, 33155
- Investigational Site Number 840459
-
Oviedo, Florida, Forenede Stater, 32765
- Investigational Site Number 840432
-
Panama City, Florida, Forenede Stater, 32401
- Investigational Site Number 840318
-
St. Petersburg, Florida, Forenede Stater, 33707
- Investigational Site Number 840056
-
Wellington, Florida, Forenede Stater, 33449
- Investigational Site Number 840295
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Investigational Site Number 840066
-
Atlanta, Georgia, Forenede Stater, 30322
- Investigational Site Number 840446
-
Atlanta, Georgia, Forenede Stater, 30322
- Investigational Site Number 840487
-
Blue Ridge, Georgia, Forenede Stater, 30513
- Investigational Site Number 840578
-
Columbus, Georgia, Forenede Stater, 31904-5245
- Investigational Site Number 840534
-
Duluth, Georgia, Forenede Stater, 30096
- Investigational Site Number 840447
-
Duluth, Georgia, Forenede Stater, 30096
- Investigational Site Number 840499
-
-
Idaho
-
Idaho Falls, Idaho, Forenede Stater, 83404
- Investigational Site Number 840536
-
Pocatello, Idaho, Forenede Stater, 83201
- Investigational Site Number 840413
-
-
Illinois
-
Arlington Heights, Illinois, Forenede Stater, 60005
- Investigational Site Number 840519
-
Belleville, Illinois, Forenede Stater, 62220
- Investigational Site Number 840589
-
Chicago, Illinois, Forenede Stater, 60415
- Investigational Site Number 840107
-
Chicago, Illinois, Forenede Stater, 60611
- Investigational Site Number 840633
-
Chicago, Illinois, Forenede Stater, 60612
- Investigational Site Number 840663
-
Hines, Illinois, Forenede Stater, 60141
- Investigational Site Number 840212
-
Joliet, Illinois, Forenede Stater, 60435
- Investigational Site Number 840345
-
Peoria, Illinois, Forenede Stater, 61602
- Investigational Site Number 840681
-
-
Indiana
-
Elwood, Indiana, Forenede Stater, 46036
- Investigational Site Number 840360
-
Gary, Indiana, Forenede Stater, 46409
- Investigational Site Number 840676
-
Hammond, Indiana, Forenede Stater, 46320
- Investigational Site Number 840657
-
Huntington, Indiana, Forenede Stater, 46750
- Investigational Site Number 840621
-
Indianapolis, Indiana, Forenede Stater, 46202
- Investigational Site Number 840702
-
-
Kansas
-
Topeka, Kansas, Forenede Stater, 66606
- Investigational Site Number 840009
-
-
Kentucky
-
Covington, Kentucky, Forenede Stater, 41011
- Investigational Site Number 840533
-
Madisonville, Kentucky, Forenede Stater, 42431
- Investigational Site Number 840251
-
Owensboro, Kentucky, Forenede Stater, 42303
- Investigational Site Number 840168
-
Pikeville, Kentucky, Forenede Stater, 41501
- Investigational Site Number 840449
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70808
- Investigational Site Number 840299
-
Hammond, Louisiana, Forenede Stater, 70403
- Investigational Site Number 840671
-
Metairie, Louisiana, Forenede Stater, 70006
- Investigational Site Number 840470
-
Shreveport, Louisiana, Forenede Stater, 71130
- Investigational Site Number 840178
-
-
Maryland
-
Annapolis, Maryland, Forenede Stater, 21401
- Investigational Site Number 840043
-
Catonsville, Maryland, Forenede Stater, 21228
- Investigational Site Number 840639
-
Rockville, Maryland, Forenede Stater, 20852
- Investigational Site Number 840430
-
Takoma Park, Maryland, Forenede Stater, 20912
- Investigational Site Number 840640
-
Towson, Maryland, Forenede Stater, 21204
- Investigational Site Number 840293
-
-
Michigan
-
Alpena, Michigan, Forenede Stater, 49707
- Investigational Site Number 840019
-
Buckley, Michigan, Forenede Stater, 49620
- Investigational Site Number 840352
-
Chesterfield, Michigan, Forenede Stater, 48047
- Investigational Site Number 840555
-
Dearborn, Michigan, Forenede Stater, 48124
- Investigational Site Number 840411
-
Detroit, Michigan, Forenede Stater, 48235
- Investigational Site Number 840205
-
Flint, Michigan, Forenede Stater, 48503
- Investigational Site Number 840581
-
Kalamazoo, Michigan, Forenede Stater, 49048
- Investigational Site Number 840404
-
Southfield, Michigan, Forenede Stater, 48075
- Investigational Site Number 840312
-
Sterling Heights, Michigan, Forenede Stater, 48310
- Investigational Site Number 840484
-
-
Minnesota
-
Duluth, Minnesota, Forenede Stater, 55805
- Investigational Site Number 840219
-
Eagan, Minnesota, Forenede Stater, 55122
- Investigational Site Number 840199
-
-
Mississippi
-
Biloxi, Mississippi, Forenede Stater, 39531
- Investigational Site Number 840196
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64111
- Investigational Site Number 840445
-
Kansas City, Missouri, Forenede Stater, 64128
- Investigational Site Number 840008
-
St. Louis, Missouri, Forenede Stater, 63122
- Investigational Site Number 840091
-
St. Louis, Missouri, Forenede Stater, 63128
- Investigational Site Number 840046
-
St. Louis, Missouri, Forenede Stater, 63131
- Investigational Site Number 840678
-
St. Louis, Missouri, Forenede Stater, 63141
- Investigational Site Number 840400
-
-
Montana
-
Kalispell, Montana, Forenede Stater, 59901
- Investigational Site Number 840337
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68521
- Investigational Site Number 840509
-
Omaha, Nebraska, Forenede Stater, 68131
- Investigational Site Number 840007
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89102
- Investigational Site Number 840382
-
Las Vegas, Nevada, Forenede Stater, 89102
- Investigational Site Number 840680
-
Las Vegas, Nevada, Forenede Stater, 89148
- Investigational Site Number 840217
-
-
New Jersey
-
Linden, New Jersey, Forenede Stater
- Investigational Site Number 840072
-
Ridgewood, New Jersey, Forenede Stater, 07450
- Investigational Site Number 840628
-
Somerset, New Jersey, Forenede Stater, 08873
- Investigational Site Number 840162
-
-
New York
-
Albany, New York, Forenede Stater, 12206
- Investigational Site Number 840285
-
Jamaica, New York, Forenede Stater, 11432
- Investigational Site Number 840585
-
Mineola, New York, Forenede Stater, 11501
- Investigational Site Number 840348
-
Northport, New York, Forenede Stater, 11768
- Investigational Site Number 840119
-
Rosedale, New York, Forenede Stater, 14221
- Investigational Site Number 840696
-
-
North Carolina
-
Asheville, North Carolina, Forenede Stater, 28805
- Investigational Site Number 840310
-
Calabash, North Carolina, Forenede Stater, 28467
- Investigational Site Number 840454
-
Charlotte, North Carolina, Forenede Stater, 28203
- Investigational Site Number 840672
-
Charlotte, North Carolina, Forenede Stater, 28205
- Investigational Site Number 840152
-
Elizabeth City, North Carolina, Forenede Stater, 27909
- Investigational Site Number 840344
-
Greensboro, North Carolina, Forenede Stater, 27401
- Investigational Site Number 840328
-
Greensboro, North Carolina, Forenede Stater, 27405
- Investigational Site Number 840513
-
Greenville, North Carolina, Forenede Stater, 27858
- Investigational Site Number 840504
-
Monroe, North Carolina, Forenede Stater, 28110
- Investigational Site Number 840642
-
Raleigh, North Carolina, Forenede Stater, 27609
- Investigational Site Number 840481
-
Wilmington, North Carolina, Forenede Stater, 28401
- Investigational Site Number 840381
-
Winston Salem, North Carolina, Forenede Stater, 27157-1071
- Investigational Site Number 840532
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- Investigational Site Number 840028
-
Cincinnati, Ohio, Forenede Stater, 45220
- Investigational Site Number 840198
-
Columbus, Ohio, Forenede Stater, 43201
- Investigational Site Number 840543
-
Dayton, Ohio, Forenede Stater, 45439
- Investigational Site Number 840456
-
Marion, Ohio, Forenede Stater, 43302
- Investigational Site Number 840368
-
-
Oregon
-
Bend, Oregon, Forenede Stater, 97701
- Investigational Site Number 840427
-
Portland, Oregon, Forenede Stater, 97201-3098
- Investigational Site Number 840422
-
Portland, Oregon, Forenede Stater, 97227-1191
- Investigational Site Number 840511
-
-
Pennsylvania
-
Butler, Pennsylvania, Forenede Stater, 16001
- Investigational Site Number 840560
-
Clark Summit, Pennsylvania, Forenede Stater, 18411
- Investigational Site Number 840464
-
Pittsburgh, Pennsylvania, Forenede Stater, 15220
- Investigational Site Number 840401
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02908
- Investigational Site Number 840266
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- Investigational Site Number 840223
-
Columbia, South Carolina, Forenede Stater, 29201
- Investigational Site Number 840353
-
Green Ville, South Carolina, Forenede Stater, 29605
- Investigational Site Number 840529
-
Greer, South Carolina, Forenede Stater, 29651
- Investigational Site Number 840550
-
Myrtle Beach, South Carolina, Forenede Stater, 29572
- Investigational Site Number 840258
-
Taylors, South Carolina, Forenede Stater, 29687-4105
- Investigational Site Number 840309
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Investigational Site Number 840551
-
-
Tennessee
-
Bartlett, Tennessee, Forenede Stater, 38133
- Investigational Site Number 840524
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Investigational Site Number 840308
-
Germantown, Tennessee, Forenede Stater, 38138
- Investigational Site Number 840047
-
Jackson, Tennessee, Forenede Stater, 38305
- Investigational Site Number 840313
-
Memphis, Tennessee, Forenede Stater, 38114
- Investigational Site Number 840625
-
Memphis, Tennessee, Forenede Stater, 38163
- Investigational Site Number 840637
-
Nashville, Tennessee, Forenede Stater, 37208
- Investigational Site Number 840096
-
Nashville, Tennessee, Forenede Stater, 37232
- Investigational Site Number 840388
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75246
- Investigational Site Number 840473
-
Edinburg, Texas, Forenede Stater, 78539
- Investigational Site Number 840677
-
El Paso, Texas, Forenede Stater, 79925
- Investigational Site Number 840698
-
Fair Oaks Ranch, Texas, Forenede Stater, 78015
- Investigational Site Number 840439
-
Houston, Texas, Forenede Stater, 77081
- Investigational Site Number 840164
-
Longview, Texas, Forenede Stater, 75605
- Investigational Site Number 840545
-
Lubbock, Texas, Forenede Stater, 79409
- Investigational Site Number 840385
-
Lubbock, Texas, Forenede Stater, 79409
- Investigational Site Number 840530
-
Marshall, Texas, Forenede Stater, 75670
- Investigational Site Number 840174
-
Plano, Texas, Forenede Stater, 75024
- Investigational Site Number 840565
-
Richmond, Texas, Forenede Stater, 77469
- Investigational Site Number 840608
-
San Antonio, Texas, Forenede Stater, 78258
- Investigational Site Number 840573
-
Sugarland, Texas, Forenede Stater, 77479
- Investigational Site Number 840564
-
Waco, Texas, Forenede Stater, 76708
- Investigational Site Number 840241
-
-
Utah
-
American Fork, Utah, Forenede Stater, 84003
- Investigational Site Number 840232
-
Draper, Utah, Forenede Stater, 84020
- Investigational Site Number 840471
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908-0679
- Investigational Site Number 840503
-
Chesapeake, Virginia, Forenede Stater, 23320
- Investigational Site Number 840180
-
Chesapeake, Virginia, Forenede Stater, 23321
- Investigational Site Number 840465
-
Chesapeake, Virginia, Forenede Stater, 23323
- Investigational Site Number 840128
-
Norfolk, Virginia, Forenede Stater, 23502
- Investigational Site Number 840045
-
Norfolk, Virginia, Forenede Stater, 23510
- Investigational Site Number 840213
-
Richmond, Virginia, Forenede Stater, 23219
- Investigational Site Number 840001
-
Roanoke, Virginia, Forenede Stater, 24014
- Investigational Site Number 840286
-
-
Washington
-
Olympia, Washington, Forenede Stater, 98506
- Investigational Site Number 840170
-
Spokane, Washington, Forenede Stater, 99207
- Investigational Site Number 840094
-
Spokane, Washington, Forenede Stater, 99207
- Investigational Site Number 840343
-
Spokane, Washington, Forenede Stater, 99220
- Investigational Site Number 840268
-
Tacoma, Washington, Forenede Stater, 98405
- Investigational Site Number 840061
-
-
Wisconsin
-
Fairmount, Wisconsin, Forenede Stater, 26554
- Investigational Site Number 840613
-
Lacrosse, Wisconsin, Forenede Stater, 54601
- Investigational Site Number 840121
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Investigational Site Number 840493
-
-
-
-
-
Brest Cedex, Frankrig, 29610
- Investigational Site Number 250008
-
Corbeil Essonnes, Frankrig, 91109
- Investigational Site Number 250002
-
Nantes, Frankrig, 44093
- Investigational Site Number 250005
-
Nimes, Frankrig, 30029
- Investigational Site Number 250014
-
Paris Cedex 15, Frankrig, 75908
- Investigational Site Number 250007
-
Pessac, Frankrig, 33600
- Investigational Site Number 250011
-
Poitiers Cedex, Frankrig, 86021
- Investigational Site Number 250012
-
Rennes, Frankrig, 35700
- Investigational Site Number 250006
-
Toulouse Cedex 4, Frankrig, 31403
- Investigational Site Number 250001
-
-
-
-
-
Batumi, Georgien
- Investigational Site Number 268003
-
Kutaisi, Georgien
- Investigational Site Number 268004
-
Tbilisi, Georgien
- Investigational Site Number 268001
-
Tbilisi, Georgien
- Investigational Site Number 268002
-
-
-
-
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320001
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320004
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320006
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320012
-
Guatemala, Guatemala, 01010
- Investigational Site Number 320014
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320002
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320007
-
Guatemala, Guatemala, 01014
- Investigational Site Number 320008
-
Guatemala, Guatemala, 01015
- Investigational Site Number 320011
-
Quetzaltenango, Guatemala, 09001
- Investigational Site Number 320015
-
-
-
-
-
Alkmaar, Holland, 1815 JD
- Investigational Site Number 528005
-
Den Haag, Holland, 2597 AX
- Investigational Site Number 528007
-
Deventer, Holland, 7416 SE
- Investigational Site Number 528008
-
Hoorn, Holland, 1625 HV
- Investigational Site Number 528004
-
Rotterdam, Holland, 3045 PM
- Investigational Site Number 528001
-
Tilburg, Holland, 5022 GC
- Investigational Site Number 528003
-
Venlo, Holland, 5912 BL
- Investigational Site Number 528006
-
-
-
-
-
Minsk, Hviderusland, 220116
- Investigational Site Number 112001
-
Minsk, Hviderusland, 220036
- Investigational Site Number 112002
-
Minsk, Hviderusland, 220096
- Investigational Site Number 112003
-
-
-
-
-
Ahmedabad, Indien, 380052
- Investigational Site Number 356019
-
Bangalore, Indien, 560043
- Investigational Site Number 356002
-
Bangalore, Indien, 560092
- Investigational Site Number 356010
-
Bangalore, Indien, 562114
- Investigational Site Number 356026
-
Belgaum, Indien, 590001
- Investigational Site Number 356024
-
Chandigarh, Indien, 160062
- Investigational Site Number 356012
-
Cochin, Indien, 682026
- Investigational Site Number 356016
-
Gurgaon, Indien, 122002
- Investigational Site Number 356022
-
Hubli, Indien, 580021
- Investigational Site Number 356029
-
Hyderabad, Indien, 500063
- Investigational Site Number 356020
-
Jaipur, Indien, 302001
- Investigational Site Number 356031
-
Kolkata, Indien
- Investigational Site Number 356004
-
Lucknow, Indien, 226003
- Investigational Site Number 356015
-
Lucknow, Indien
- Investigational Site Number 356014
-
Ludhiana, Indien, 141001
- Investigational Site Number 356009
-
Madurai, Indien
- Investigational Site Number 356025
-
Mangalore, Indien, 575002
- Investigational Site Number 356032
-
Manipal, Indien, 576104
- Investigational Site Number 356018
-
Mysore, Indien, 570020
- Investigational Site Number 356023
-
Nagpur, Indien, 440010
- Investigational Site Number 356027
-
Nagpur, Indien
- Investigational Site Number 356006
-
Nashik, Indien, 422005
- Investigational Site Number 356034
-
Nasik, Indien, 422002
- Investigational Site Number 356030
-
New Delhi, Indien, 110017
- Investigational Site Number 356013
-
New Delhi, Indien, 122001
- Investigational Site Number 356017
-
Pune, Indien, 411001
- Investigational Site Number 356021
-
Pune, Indien, 411019
- Investigational Site Number 356028
-
-
-
-
-
Afula, Israel, 18101
- Investigational Site Number 376010
-
Givatayim, Israel, 53583
- Investigational Site Number 376006
-
Haifa, Israel, 31096
- Investigational Site Number 376002
-
Haifa, Israel, 35251
- Investigational Site Number 376008
-
Holon, Israel, 58100
- Investigational Site Number 376001
-
Jerusalem, Israel, 91120
- Investigational Site Number 376012
-
Nahariya, Israel, 22100
- Investigational Site Number 376011
-
Safed, Israel, 13100
- Investigational Site Number 376005
-
Tel Aviv, Israel, 64239
- Investigational Site Number 376004
-
Tel Hashomer, Israel, 52621
- Investigational Site Number 376003
-
Tzrifin, Israel, 70300
- Investigational Site Number 376009
-
-
-
-
-
Carpi, Italien, 41012
- Investigational Site Number 380024
-
Chieri, Italien, 10023
- Investigational Site Number 380004
-
Chieti, Italien, 66013
- Investigational Site Number 380002
-
Fermo, Italien, 63023
- Investigational Site Number 380006
-
Firenze, Italien, 50141
- Investigational Site Number 380010
-
Genova, Italien, 16011
- Investigational Site Number 380009
-
Messina, Italien, 98124
- Investigational Site Number 380016
-
Milano, Italien, 20122
- Investigational Site Number 380023
-
Milano, Italien, 20132
- Investigational Site Number 380011
-
Milano, Italien, 20142
- Investigational Site Number 380012
-
Napoli, Italien, 80131
- Investigational Site Number 380014
-
Novara, Italien, 28100
- Investigational Site Number 380019
-
Palermo, Italien, 90127
- Investigational Site Number 380005
-
Pisa, Italien, 56124
- Investigational Site Number 380001
-
Roma, Italien, 00128
- Investigational Site Number 380013
-
Rozzano, Italien, 20089
- Investigational Site Number 380020
-
-
-
-
-
Chuo-Ku, Japan
- Investigational Site Number 392011
-
Fuchu-Shi, Japan
- Investigational Site Number 392015
-
Fujisawa-Shi, Japan
- Investigational Site Number 392012
-
Hachioji-Shi, Japan
- Investigational Site Number 392025
-
Hakusan-Shi, Japan
- Investigational Site Number 392027
-
Hamamatsu-Shi, Japan
- Investigational Site Number 392005
-
Hitachi-Shi, Japan
- Investigational Site Number 392022
-
Itabashi-Ku, Japan
- Investigational Site Number 392003
-
Itabashi-Ku, Japan
- Investigational Site Number 392017
-
Kawanishi-Shi, Japan
- Investigational Site Number 392019
-
Kobe-Shi, Japan
- Investigational Site Number 392013
-
Matsuyama-Shi, Japan
- Investigational Site Number 392007
-
Matsuyama-Shi, Japan
- Investigational Site Number 392008
-
Nagasaki-Shi, Japan
- Investigational Site Number 392009
-
Noda-Shi, Japan
- Investigational Site Number 392002
-
Osaka-Shi, Japan
- Investigational Site Number 392021
-
Osaka-Shi, Japan
- Investigational Site Number 392020
-
Sapporo-Shi, Japan
- Investigational Site Number 392001
-
Sapporo-Shi, Japan
- Investigational Site Number 392010
-
Setagaya-Ku, Japan
- Investigational Site Number 392024
-
Shinagawa-Ku, Japan
- Investigational Site Number 392004
-
Shirakawa-Shi, Japan
- Investigational Site Number 392014
-
Suita-Shi, Japan
- Investigational Site Number 392018
-
Tachikawa-Shi, Japan
- Investigational Site Number 392016
-
Takasaki-Shi, Japan
- Investigational Site Number 392023
-
-
-
-
-
Ankara, Kalkun, 06110
- Investigational Site Number 792004
-
Ankara, Kalkun, 06490
- Investigational Site Number 792002
-
Ankara, Kalkun
- Investigational Site Number 792012
-
Capa / Istanbul, Kalkun, 34390
- Investigational Site Number 792001
-
Istanbul, Kalkun, 34010
- Investigational Site Number 792015
-
Istanbul, Kalkun, 34034
- Investigational Site Number 792008
-
Istanbul, Kalkun, 34385
- Investigational Site Number 792014
-
Izmir, Kalkun, 35100
- Investigational Site Number 792003
-
Izmir, Kalkun, 35100
- Investigational Site Number 792007
-
Mersin, Kalkun, 33169
- Investigational Site Number 792011
-
Samsun, Kalkun, 55200
- Investigational Site Number 792013
-
-
-
-
-
Beijing, Kina, 100853
- Investigational Site Number 156001
-
Beijing, Kina, 100029
- Investigational Site Number 156016
-
Beijing, Kina, 100029
- Investigational Site Number 156034
-
Beijing, Kina, 100034
- Investigational Site Number 156024
-
Beijing, Kina, 100037
- Investigational Site Number 156028
-
Beijing, Kina, 100088
- Investigational Site Number 156014
-
Beijing, Kina, 100730
- Investigational Site Number 156005
-
Beijing, Kina, 100730
- Investigational Site Number 156006
-
Dalian, Kina, 116011
- Investigational Site Number 156008
-
Guangzhou, Kina, 510080
- Investigational Site Number 156020
-
Jinan, Kina, 250012
- Investigational Site Number 156023
-
Jinan, Kina, 250013
- Investigational Site Number 156015
-
Nanjing, Kina, 210008
- Investigational Site Number 156009
-
Shanghai, Kina, 200003
- Investigational Site Number 156013
-
Shanghai, Kina, 200080
- Investigational Site Number 156019
-
Shenyang, Kina, 110004
- Investigational Site Number 156032
-
Shenyang, Kina, 110016
- Investigational Site Number 156022
-
Suzhou, Kina, 215006
- Investigational Site Number 156004
-
Urumchi, Kina, 830054
- Investigational Site Number 156033
-
-
-
-
-
Bucheon, Korea, Republikken, 420-767
- Investigational Site Number 410012
-
Daegu, Korea, Republikken, 705-717
- Investigational Site Number 410006
-
Gwangju, Korea, Republikken, 501-757
- Investigational Site Number 410009
-
Incheon, Korea, Republikken, 400-711
- Investigational Site Number 410008
-
Incheon, Korea, Republikken, 405-760
- Investigational Site Number 410001
-
Seongnam, Korea, Republikken, 463-707
- Investigational Site Number 410004
-
Seoul, Korea, Republikken, 110-744
- Investigational Site Number 410014
-
Seoul, Korea, Republikken, 134-727
- Investigational Site Number 410013
-
Seoul, Korea, Republikken, 135-720
- Investigational Site Number 410002
-
Seoul, Korea, Republikken, 152-703
- Investigational Site Number 410011
-
Seoul, Korea, Republikken, 156-755
- Investigational Site Number 410010
-
Wonju, Korea, Republikken, 220-701
- Investigational Site Number 410007
-
-
-
-
-
Cesis, Letland, LV-4101
- Investigational Site Number 428005
-
Daugavpils, Letland, LV-5417
- Investigational Site Number 428001
-
Liepaja, Letland, LV-3414
- Investigational Site Number 428002
-
Riga, Letland, LV-1002
- Investigational Site Number 428003
-
Riga, Letland, LV-1011
- Investigational Site Number 428007
-
Riga, Letland, LV-1038
- Investigational Site Number 428004
-
Sigulda, Letland, LV-2150
- Investigational Site Number 428006
-
-
-
-
-
Kaunas, Litauen, LT-50009
- Investigational Site Number 440002
-
Kaunas, Litauen, LT-49456
- Investigational Site Number 440003
-
Klaipeda, Litauen, LT-91131
- Investigational Site Number 440004
-
Klaipeda, Litauen, LT-92304
- Investigational Site Number 440006
-
Panevezys, Litauen, LT-37355
- Investigational Site Number 440005
-
Vilnius, Litauen, LT-08661
- Investigational Site Number 440001
-
-
-
-
-
Acapulco, Mexico, 39670
- Investigational Site Number 484011
-
Aguascalientes, Mexico, 20230
- Investigational Site Number 484008
-
Aguascalientes, Mexico, 20230
- Investigational Site Number 484033
-
Chihuahua, Mexico, 31000
- Investigational Site Number 484016
-
Ciudad Madero, Mexico, 89440
- Investigational Site Number 484023
-
Durango, Mexico, 34000
- Investigational Site Number 484007
-
Durango, Mexico, 34080
- Investigational Site Number 484001
-
Durango, Mexico, 34080
- Investigational Site Number 484041
-
Guadalajara, Mexico, 44150
- Investigational Site Number 484032
-
Guadalajara, Mexico, 44160
- Investigational Site Number 484034
-
Guadalajara, Mexico, 44210
- Investigational Site Number 484014
-
Guadalajara, Mexico, 44210
- Investigational Site Number 484028
-
Guadalajara, Mexico, 44670
- Investigational Site Number 484021
-
Guadalajara, Mexico, 44680
- Investigational Site Number 484006
-
Guadalajara, Mexico, 45200
- Investigational Site Number 484018
-
Leon, Mexico, 37150
- Investigational Site Number 484024
-
Mexico City, Mexico, 06470
- Investigational Site Number 484026
-
Mexico City, Mexico, 07300
- Investigational Site Number 484022
-
Mexico City, Mexico, 14000
- Investigational Site Number 484013
-
Monterrey, Mexico, 64460
- Investigational Site Number 484005
-
Monterrey, Mexico, 64460
- Investigational Site Number 484002
-
Monterrey, Mexico, 64020
- Investigational Site Number 484003
-
Monterrey, Mexico, 64060
- Investigational Site Number 484025
-
Monterrey, Mexico, 64620
- Investigational Site Number 484004
-
Morelia, Mexico, 58260
- Investigational Site Number 484035
-
San Luis Potosi, Mexico, 78200
- Investigational Site Number 484020
-
Tlalnepantla, Mexico, 54055
- Investigational Site Number 484017
-
Xalapa, Mexico, 91020
- Investigational Site Number 484031
-
-
-
-
-
Bodø, Norge, 8092
- Investigational Site Number 578003
-
Haugesund, Norge, 5528
- Investigational Site Number 578002
-
Stavanger, Norge, 4095
- Investigational Site Number 578001
-
-
-
-
-
Cuidad De Panama, Panama
- Investigational Site Number 591001
-
Cuidad De Panama, Panama
- Investigational Site Number 591003
-
La Chorrera, Panama
- Investigational Site Number 591004
-
Penonome, Panama
- Investigational Site Number 591002
-
-
-
-
-
Arequipa, Peru, 5154
- Investigational Site Number 604007
-
Callao, Peru, CALLAO 2
- Investigational Site Number 604014
-
Lima, Peru, 051
- Investigational Site Number 604011
-
Lima, Peru, 27
- Investigational Site Number 604002
-
Lima, Peru, 051
- Investigational Site Number 604019
-
Lima, Peru, 11
- Investigational Site Number 604013
-
Lima, Peru, 12
- Investigational Site Number 604010
-
Lima, Peru, 27
- Investigational Site Number 604006
-
Lima, Peru, 511
- Investigational Site Number 604015
-
Lima, Peru, 511
- Investigational Site Number 604016
-
Lima, Peru, LIMA 01
- Investigational Site Number 604017
-
Lima, Peru, LIMA 11
- Investigational Site Number 604018
-
Lima, Peru, LIMA 14
- Investigational Site Number 604005
-
Lima, Peru, LIMA 27
- Investigational Site Number 604009
-
Lima, Peru, LIMA 31
- Investigational Site Number 604001
-
-
-
-
-
?ód?, Polen, 91-087
- Investigational Site Number 616005
-
Bialystok, Polen, 15-276
- Investigational Site Number 616008
-
Bydgoszcz, Polen, 85-046
- Investigational Site Number 616019
-
Czeladz, Polen, 41-250
- Investigational Site Number 616012
-
Czestochowa, Polen, 42-217
- Investigational Site Number 616007
-
Gdynia, Polen, 81-394
- Investigational Site Number 616014
-
Gliwice, Polen, 44-100
- Investigational Site Number 616013
-
Grodzisk Mazowiecki, Polen, 05-825
- Investigational Site Number 616028
-
Katowice, Polen, 40-767
- Investigational Site Number 616022
-
Krakow, Polen, 30-082
- Investigational Site Number 616001
-
Krakow, Polen, 31-024
- Investigational Site Number 616024
-
Leczyca, Polen, 99-100
- Investigational Site Number 616029
-
Poland, Polen, 42-500
- Investigational Site Number 616023
-
Pulawy, Polen, 24-100
- Investigational Site Number 616021
-
Ruda Slaska, Polen, 41-706
- Investigational Site Number 616006
-
Szczecin, Polen, 70-506
- Investigational Site Number 616025
-
Warszawa, Polen, 00-685
- Investigational Site Number 616032
-
Wroclaw, Polen, 50-088
- Investigational Site Number 616020
-
Wroclaw, Polen, 50-981
- Investigational Site Number 616011
-
Zgierz, Polen, 95-100
- Investigational Site Number 616031
-
-
-
-
-
Amadora, Portugal, 2720-276
- Investigational Site Number 620005
-
Coimbra, Portugal, 3000-075
- Investigational Site Number 620003
-
Lisboa, Portugal, 1349-019
- Investigational Site Number 620001
-
Penafiel, Portugal, 4564-007
- Investigational Site Number 620007
-
Porto, Portugal, 4200
- Investigational Site Number 620006
-
-
-
-
-
Arad, Rumænien, 310158
- Investigational Site Number 642029
-
Baia Mare, Rumænien, 430123
- Investigational Site Number 642020
-
Braila, Rumænien, 810249
- Investigational Site Number 642019
-
Brasov, Rumænien, 500365
- Investigational Site Number 642003
-
Bucharest, Rumænien, 010825
- Investigational Site Number 642034
-
Bucuresti, Rumænien, 020475
- Investigational Site Number 642022
-
Bucuresti, Rumænien, 021392
- Investigational Site Number 642001
-
Bucuresti, Rumænien, 050098
- Investigational Site Number 642013
-
Cluj Napoca, Rumænien, 40001
- Investigational Site Number 642026
-
Craiova, Rumænien, 200147
- Investigational Site Number 642030
-
Craiova, Rumænien, 200642
- Investigational Site Number 642015
-
Deva, Rumænien, 330084
- Investigational Site Number 642007
-
Iasi, Rumænien, 700547
- Investigational Site Number 642011
-
Iasi, Rumænien, 700732
- Investigational Site Number 642010
-
Oradea, Rumænien, 410598
- Investigational Site Number 642016
-
Pitesti, Rumænien, 110084
- Investigational Site Number 642033
-
Ploiesti, Rumænien, 100097
- Investigational Site Number 642002
-
Suceava, Rumænien, 720262
- Investigational Site Number 642009
-
Targu Mures, Rumænien, 540099
- Investigational Site Number 642014
-
Targu Mures, Rumænien, 540142
- Investigational Site Number 642012
-
Timisoara, Rumænien, 300174
- Investigational Site Number 642018
-
Timisoara, Rumænien, 300736
- Investigational Site Number 642031
-
-
-
-
-
Lugano, Schweiz, 6900
- Investigational Site Number 756003
-
-
-
-
-
Belgrade, Serbien, 11000
- Investigational Site Number 688002
-
Belgrade, Serbien, 11000
- Investigational Site Number 688003
-
Belgrade, Serbien, 11000
- Investigational Site Number 688006
-
Belgrade, Serbien, 11000
- Investigational Site Number 688008
-
Belgrade, Serbien, 11000
- Investigational Site Number 688010
-
Belgrade, Serbien, 11000
- Investigational Site Number 688004
-
Belgrade, Serbien, 11000
- Investigational Site Number 688009
-
Belgrade, Serbien, 11040
- Investigational Site Number 688001
-
Nis, Serbien, 18000
- Investigational Site Number 688005
-
Nis, Serbien, 18000
- Investigational Site Number 688007
-
-
-
-
-
Alcalá De Henares, Spanien, 28805
- Investigational Site Number 724005
-
Almería, Spanien, 04120
- Investigational Site Number 724016
-
Barakaldo, Spanien, 48903
- Investigational Site Number 724012
-
Barcelona, Spanien, 08036
- Investigational Site Number 724018
-
Bilbao, Spanien, 48013
- Investigational Site Number 724014
-
Cáceres, Spanien, 10003
- Investigational Site Number 724015
-
La Coruña, Spanien, 15006
- Investigational Site Number 724013
-
Lérida, Spanien, 25198
- Investigational Site Number 724008
-
Madrid, Spanien, 28046
- Investigational Site Number 724011
-
Murcia, Spanien, 30120
- Investigational Site Number 724017
-
Oviedo, Spanien, 33006
- Investigational Site Number 724022
-
Pontevedra, Spanien, 36071
- Investigational Site Number 724003
-
Sevilla, Spanien, 41014
- Investigational Site Number 724001
-
Valencia, Spanien, 46010
- Investigational Site Number 724020
-
Vigo, Spanien, 36211
- Investigational Site Number 724004
-
-
-
-
-
Karlstad, Sverige, 651 85
- Investigational Site Number 752012
-
Kristianstad, Sverige, 29185
- Investigational Site Number 752011
-
Ljungby, Sverige, 341 82
- Investigational Site Number 752006
-
Oskarshamn, Sverige, 572 28
- Investigational Site Number 752009
-
Stockholm, Sverige, 118 83
- Investigational Site Number 752004
-
Stockholm, Sverige, 182 88
- Investigational Site Number 752007
-
Växjö, Sverige, 351 85
- Investigational Site Number 752002
-
-
-
-
-
Alberton, Sydafrika, 1450
- Investigational Site Number 710020
-
Cape Town, Sydafrika, 7405
- Investigational Site Number 710017
-
Cape Town, Sydafrika, 7530
- Investigational Site Number 710006
-
Cape Town, Sydafrika, 7764
- Investigational Site Number 710010
-
Cape Town, Sydafrika, 7925
- Investigational Site Number 710025
-
Chatsworth, Sydafrika, 4091
- Investigational Site Number 710008
-
Durban, Sydafrika
- Investigational Site Number 710011
-
George, Sydafrika, 6529
- Investigational Site Number 710015
-
Kempton Park, Sydafrika, 1619
- Investigational Site Number 710019
-
Paarl, Sydafrika, 7646
- Investigational Site Number 710014
-
Parow, Sydafrika, 7500
- Investigational Site Number 710023
-
Pretoria, Sydafrika, 0002
- Investigational Site Number 710002
-
Pretoria, Sydafrika, 181
- Investigational Site Number 710001
-
Richards Bay, Sydafrika, 3900
- Investigational Site Number 710005
-
Somerset West, Sydafrika, 7130
- Investigational Site Number 710007
-
Worcester, Sydafrika, 6850
- Investigational Site Number 710004
-
-
-
-
-
Chia-Yi, Taiwan, 60002
- Investigational Site Number 158005
-
Taichung, Taiwan, 402
- Investigational Site Number 158004
-
Tainan Hsien, Taiwan, 710
- Investigational Site Number 158006
-
Taipei, Taiwan, 112
- Investigational Site Number 158001
-
Taipei, Taiwan, 100
- Investigational Site Number 158002
-
Taipei, Taiwan, 220
- Investigational Site Number 158008
-
Taipei 111, Taiwan, 111
- Investigational Site Number 158007
-
Taipei Hsien, Taiwan, 23137
- Investigational Site Number 158003
-
-
-
-
-
Sfax, Tunesien, 3029
- Investigational Site Number 788003
-
Tunis, Tunesien, 1006
- Investigational Site Number 788005
-
Tunis, Tunesien, 1007
- Investigational Site Number 788004
-
Tunis, Tunesien, 1008
- Investigational Site Number 788002
-
Tunis, Tunesien, 1027
- Investigational Site Number 788001
-
-
-
-
-
Berlin, Tyskland, 13347
- Investigational Site Number 276003
-
Bochum, Tyskland, 44787
- Investigational Site Number 276022
-
Chemnitz, Tyskland, 09111
- Investigational Site Number 276005
-
Dresden, Tyskland, 01067
- Investigational Site Number 276021
-
Dresden, Tyskland, 01099
- Investigational Site Number 276024
-
Elsterwerda, Tyskland, 04910
- Investigational Site Number 276007
-
Frankfurt A.M., Tyskland, 60596
- Investigational Site Number 276018
-
Frankfurt Am Main, Tyskland, 60389
- Investigational Site Number 276011
-
Görlitz, Tyskland, 02826
- Investigational Site Number 276017
-
Haßloch, Tyskland, 67454
- Investigational Site Number 276025
-
Heidelberg, Tyskland, 69120
- Investigational Site Number 276009
-
Leipzig, Tyskland, 04103
- Investigational Site Number 276019
-
Magdeburg, Tyskland, 39104
- Investigational Site Number 276020
-
Mühldorf Am Inn, Tyskland, 84453
- Investigational Site Number 276028
-
Pirna, Tyskland, 01796
- Investigational Site Number 276014
-
Pohlheim, Tyskland, 35415
- Investigational Site Number 276016
-
Rotenburg An Der Fulda, Tyskland, 36199
- Investigational Site Number 276026
-
-
-
-
-
Chernivtsi, Ukraine, 58022
- Investigational Site Number 804004
-
Dnepropetrovsk, Ukraine, 49023
- Investigational Site Number 804006
-
Dnipropetrovsk, Ukraine, 49006
- Investigational Site Number 804002
-
Kharkiv, Ukraine, 61176
- Investigational Site Number 804010
-
Kharkov, Ukraine, 61022
- Investigational Site Number 804009
-
Kiev, Ukraine, 02091
- Investigational Site Number 804003
-
Kiev, Ukraine, 02660
- Investigational Site Number 804011
-
Kyiv, Ukraine, 03680
- Investigational Site Number 804012
-
Kyiv, Ukraine, 04114
- Investigational Site Number 804013
-
Lviv, Ukraine, 79015
- Investigational Site Number 804005
-
Odessa, Ukraine, 65025
- Investigational Site Number 804007
-
Odessa, Ukraine, 65059
- Investigational Site Number 804008
-
-
-
-
-
Graz, Østrig, 8036
- Investigational Site Number 040002
-
Wien, Østrig, 1160
- Investigational Site Number 040001
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Mænd og kvinder, der oplevede en spontan ACS-hændelse (dvs. ST-segment elevation myokardieinfarkt (STEMI) eller non-ST-segment elevation MI (NSTEMI) eller ustabil angina) med en dokumenteret forhøjelse over det normale referenceområde for en hjertebiomarkør ( Troponin eller kreatininkinase (CK)-MB) og den kliniske præsentation, der stemmer overens med en ACS, som førte til indlæggelse på et akutcenter inden for 180 dage efter ACS-hændelsen og før screening.
- Deltagere med en historie med type 2-diabetes (for nyligt diagnosticerede deltagere var diagnosen baseret på Verdenssundhedsorganisationens (WHO) kriterier: dvs. enten en fastende venøs plasmaglucosekoncentration ≥ 7,0 mmol/L [126 mg/dL] eller 2- time efter glukosebelastning venøs plasmaglucose ≥ 11,1 mmol/L [200 mg/dL], bekræftet 2 gange) før screeningsbesøget.
Ekskluderingskriterier:
- Type 1 diabetes mellitus eller historie med ketoacidose inden for 6 måneder før screening.
- Glykosyleret hæmoglobin (HbA1c) <5,5 % eller >11 % målt ved screeningsbesøg.
- Påkrævet for at bruge inkretinbaserede midler (f.eks. Glukagon-lignende peptid -1 (GLP-1) agonister eller Dipeptidyl Peptidase-4 (DPP-4) hæmmere) andre end undersøgelseslægemidlet i den dobbeltblindede behandlingsperiode.
- Deltagere, der havde gennemgået en koronararterie-bypass-operation (CABG) efter den kvalificerende ACS-begivenhed.
- Deltagere, der havde gennemgået perkutan koronar intervention (PCI) inden for 15 dage før screening.
- Deltagere med planlagt revaskulariseringsprocedure (PCI eller CABG) eller koronar angiogram inden for 90 dage efter screeningsbesøg.
- Anamnese med uforklarlig pancreatitis, kronisk pancreatitis, pancreatektomi, mave/mavekirurgi, inflammatorisk tarmsygdom, personlig eller familiehistorie med medullær thyreoideacancer (MTC) eller genetiske tilstande, der disponerer for MTC (f.eks. multiple endokrine neoplasisyndromer).
- Enhver klinisk signifikant abnormitet, der identificeres på screeningstidspunktet, og som efter investigator eller en sub-investigator vurderer, ville udelukke sikker afslutning af undersøgelsen eller begrænse effektmålsvurdering såsom større systemiske sygdomme.
Ovenstående information er ikke beregnet til at indeholde alle overvejelser, der er relevante for en deltagers potentielle deltagelse i et klinisk forsøg.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo matchede med lixisenatid én gang dagligt (QD) indtil behandlingens afslutning.
|
Farmaceutisk form: Steril vandig opløsning; Indgivelsesvej: Subkutan inden for 1 time før morgenmad.
|
|
Eksperimentel: Lixisenatid
Lixisenatid 10 mcg QD i 2 uger efter randomisering, derefter ved en vedligeholdelsesdosis på 20 mcg QD op til behandlingens afslutning.
|
Farmaceutisk form: Steril vandig opløsning; Indgivelsesvej: Subkutan inden for 1 time før morgenmad med selvinjektorpen (Opticlik®).
Hvis vedligeholdelsesdosis på 20 mcg ikke blev tolereret, kunne dosis reduceres til 15 eller 10 mcg.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til første forekomst af primær CV-hændelse: CV-død, ikke-fatal MI, ikke-fatalt slagtilfælde eller hospitalsindlæggelse for ustabil angina
Tidsramme: Fra randomisering til slutningen af undersøgelsen (median opfølgning på 25 måneder)
|
Kaplan Meier-plot af den kumulative incidensrate efter behandlingsgrupper blev brugt til at afbilde begyndelsen af det primære CV-endepunkt over tid.
Antallet af observerede deltagere med endepunktshændelser blev rapporteret.
En CV-begivenhedsbedømmelseskomité (CAC) gennemgik og dømte på en blind måde alle potentielle begivenheder.
|
Fra randomisering til slutningen af undersøgelsen (median opfølgning på 25 måneder)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til første forekomst af CV-hændelse: CV-død, ikke-fatal MI, ikke-fatalt slagtilfælde, hospitalsindlæggelse for ustabil angina eller hospitalsindlæggelse for hjertesvigt
Tidsramme: Fra randomisering til slutningen af undersøgelsen (median opfølgning på 25 måneder)
|
Alle CV-hændelser blev positivt bedømt af CAC, brugt i analysen af det sammensatte CV-endepunkt bestående af CV-død, ikke-fatal MI, ikke-dødelig slagtilfælde, hospitalsindlæggelse for ustabil angina eller hospitalsindlæggelse for hjertesvigt.
Antallet af observerede deltagere med endepunktshændelser blev rapporteret.
|
Fra randomisering til slutningen af undersøgelsen (median opfølgning på 25 måneder)
|
|
Tid til første forekomst af CV-hændelse: CV-død, ikke-fatal MI, ikke-fatalt slagtilfælde, hospitalsindlæggelse for ustabil angina, hospitalsindlæggelse for hjertesvigt eller koronar revaskulariseringsprocedure
Tidsramme: Fra randomisering til slutningen af undersøgelsen (median opfølgning på 25 måneder)
|
Alle CV-hændelser blev positivt bedømt af CAC, anvendt i analysen af det sammensatte CV-endepunkt bestående af CV-død, ikke-fatal MI, ikke-dødelig slagtilfælde, hospitalsindlæggelse for ustabil angina, hospitalsindlæggelse for hjertesvigt eller koronar revaskulariseringsprocedure.
Antallet af observerede deltagere med endepunktshændelser blev rapporteret.
|
Fra randomisering til slutningen af undersøgelsen (median opfølgning på 25 måneder)
|
|
Procent ændring fra baseline i urinalbumin/kreatinin-forholdet (UACR) i uge 108
Tidsramme: Baseline til uge 108 (LOCF)
|
Tilstedeværelse af albumin i urinen er en markør for nefropati, en vigtig mikrovaskulær komplikation af diabetes.
UACR blev defineret som forholdet: mg albumin pr. gram kreatinin.
UACR-data blev logtransformeret før analysen.
Beregningen var baseret på geometrisk gennemsnit.
|
Baseline til uge 108 (LOCF)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
- Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.
- Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.
- Gerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453.
- Wijkman MO, Claggett B, Diaz R, Gerstein HC, Kober L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.
- Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.
- Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.
- Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.
- Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743.
- Wohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2010
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
17. juni 2010
Først indsendt, der opfyldte QC-kriterier
17. juni 2010
Først opslået (Skøn)
22. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EFC11319
- 2009-012852-26 (EudraCT nummer)
- U1111-1116-5558 (Anden identifikator: UTN)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .