Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluering af ugentlig Idrabiotaparinux-natrium versus oral justeret dosis Warfarin for at forhindre slagtilfælde og systemiske tromboemboliske hændelser hos patienter med atrieflimren (BOREALIS-AF)

19. februar 2016 opdateret af: Sanofi

Et multicenter, randomiseret, dobbeltblindt, bedømmerblindt, non-inferioritetsstudie, der sammenligner effektiviteten og sikkerheden af ​​en gang ugentlig subkutan biotinyleret idraparinux (SSR126517E) med oral justeret dosis Warfarin til forebyggelse af slagtilfælde og systemisk tromboemboli hos patienter Atrieflimren

Formålet er at evaluere, om en gang ugentlig subkutan (SC) injektion af idrabiotaparinuxnatrium (biotinyleret idraparinux) er mindst lige så effektiv til at forhindre blodpropper i hjernen og i de andre organer end oral international normalized ratio (INR) justeret dosis warfarin hos patienter med atrieflimren (AF).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Studiets afslutning er defineret ved en fælles studieslutdato for alle deltagere, defineret som 9 måneder (39 uger) efter den sidste randomiserede deltager.

Alle deltagere vil modtage oral warfarin (eller matchende placebo) og ugentlige SC-injektioner af idrabiotaparinuxnatrium (eller matchende placebo) op til 6 måneder før den almindelige slutdato for undersøgelsen. Alle deltagere forventes at blive behandlet i mindst 6 måneder.

Alle deltagere vil derefter have en 6-måneders observationsperiode efter ophør af undersøgelsesbehandling.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3773

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1221
        • Sanofi-Aventis Investigational Site Number 032007
      • Buenos Aires, Argentina, 1416
        • Sanofi-Aventis Investigational Site Number 032011
      • Buenos Aires, Argentina, C1428AQK
        • Sanofi-Aventis Investigational Site Number 032001
      • Buenos Aires, Argentina, C1437JCP
        • Sanofi-Aventis Investigational Site Number 032005
      • Capital Federal, Argentina, C1094AAD
        • Sanofi-Aventis Investigational Site Number 032009
      • Corrientes, Argentina, 3400
        • Sanofi-Aventis Investigational Site Number 032012
      • Mar Del Plata, Argentina, 7600
        • Sanofi-Aventis Investigational Site Number 032006
      • Moron, Argentina
        • Sanofi-Aventis Investigational Site Number 032014
      • Salta, Argentina, 4400
        • Sanofi-Aventis Investigational Site Number 032016
      • Zarate, Argentina, 2800
        • Sanofi-Aventis Investigational Site Number 032010
  • Australien
      • Adelaide, Australien, 5035
        • Sanofi-Aventis Investigational Site Number 036006
      • Auchenflower, Australien, 4066
        • Sanofi-Aventis Investigational Site Number 036003
      • Box Hill, Australien, 3128
        • Sanofi-Aventis Investigational Site Number 036008
      • Coffs Harbour, Australien, 2450
        • Sanofi-Aventis Investigational Site Number 036005
      • Kippa Ring, Australien, 4021
        • Sanofi-Aventis Investigational Site Number 036001
      • Kippa Ring, Australien, 4021
        • Sanofi-Aventis Investigational Site Number 036002
      • Launceston, Australien, 7250
        • Sanofi-Aventis Investigational Site Number 036009
      • Woden, Australien, 2606
        • Sanofi-Aventis Investigational Site Number 036010
  • Brasilien
      • Belo Horizonte, Brasilien, 30150-221
        • Sanofi-Aventis Investigational Site Number 076019
      • Campina Grande Do Sul, Brasilien, 83430-000
        • Sanofi-Aventis Investigational Site Number 076011
      • Campinas, Brasilien, 13059-740
        • Sanofi-Aventis Investigational Site Number 076007
      • Campinas, Brasilien, 13083-190
        • Sanofi-Aventis Investigational Site Number 076013
      • Curitiba, Brasilien, 80730-150
        • Sanofi-Aventis Investigational Site Number 076001
      • Goiania, Brasilien, 74223-130
        • Sanofi-Aventis Investigational Site Number 076017
      • Goiania, Brasilien, 74605-020
        • Sanofi-Aventis Investigational Site Number 076016
      • Maceio, Brasilien, 57021-500
        • Sanofi-Aventis Investigational Site Number 076018
      • Porto Alegre, Brasilien, 90610-000
        • Sanofi-Aventis Investigational Site Number 076012
      • Porto Alegre, Brasilien, 90810-120
        • Sanofi-Aventis Investigational Site Number 076008
      • Porto Alegre, Brasilien, 91350 200
        • Sanofi-Aventis Investigational Site Number 076014
      • Recife, Brasilien, 52051-380
        • Sanofi-Aventis Investigational Site Number 076009
      • Sao Jose Do Rio Preto, Brasilien, 15015-210
        • Sanofi-Aventis Investigational Site Number 076005
      • Sao Paulo, Brasilien, 04024-002
        • Sanofi-Aventis Investigational Site Number 076010
      • Uberlandia, Brasilien, 38400 299
        • Sanofi-Aventis Investigational Site Number 076015
  • Bulgarien
      • Pleven, Bulgarien, 5800
        • Sanofi-Aventis Investigational Site Number 100004
      • Plovdiv, Bulgarien, 4003
        • Sanofi-Aventis Investigational Site Number 100005
      • Sofia, Bulgarien, 1309
        • Sanofi-Aventis Investigational Site Number 100001
      • Sofia, Bulgarien, 1606
        • Sanofi-Aventis Investigational Site Number 100002
      • Sofia, Bulgarien, 1618
        • Sanofi-Aventis Investigational Site Number 100003
  • Canada
      • London, Canada, N6A 5A5
        • Sanofi-Aventis Investigational Site Number 124014
      • Newmarket, Canada, L3Y 8C3
        • Sanofi-Aventis Investigational Site Number 124006
      • Quebec, Canada, G1V 4G5
        • Sanofi-Aventis Investigational Site Number 124012
      • Toronto, Canada, M5G 2C4
        • Sanofi-Aventis Investigational Site Number 124011
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 152004
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 152005
      • Santiago, Chile, 750-0691
        • Sanofi-Aventis Investigational Site Number 152007
      • Santiago, Chile, 8053095
        • Sanofi-Aventis Investigational Site Number 152001
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 152003
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 152008
      • Viña Del Mar, Chile, 257-0017
        • Sanofi-Aventis Investigational Site Number 152009
      • Viña Del Mar, Chile
        • Sanofi-Aventis Investigational Site Number 152006
  • Colombia
      • Bogota, Colombia
        • Sanofi-Aventis Investigational Site Number 170003
      • Bogota, Colombia
        • Sanofi-Aventis Investigational Site Number 170006
      • Bucaramanga, Colombia
        • Sanofi-Aventis Investigational Site Number 170001
      • Envigado-Antioquia, Colombia
        • Sanofi-Aventis Investigational Site Number 170005
      • Medellin, Colombia
        • Sanofi-Aventis Investigational Site Number 170002
  • Costa Rica
      • San José, Costa Rica
        • Sanofi-Aventis Investigational Site Number 188004
  • Danmark
      • Glostrup, Danmark, 2600
        • Sanofi-Aventis Investigational Site Number 208002
      • Hellerup, Danmark, 2900
        • Sanofi-Aventis Investigational Site Number 208001
      • Hvidovre, Danmark, 2650
        • Sanofi-Aventis Investigational Site Number 208007
      • København S, Danmark, 2300
        • Sanofi-Aventis Investigational Site Number 208003
      • Odense, Danmark, 5000
        • Sanofi-Aventis Investigational Site Number 208004
      • Roskilde, Danmark, 4000
        • Sanofi-Aventis Investigational Site Number 208006
      • Svendborg, Danmark, 5700
        • Sanofi-Aventis Investigational Site Number 208005
  • Den Russiske Føderation
      • Barnaul, Den Russiske Føderation, 656055
        • Sanofi-Aventis Investigational Site Number 643033
      • Chelyabinsk, Den Russiske Føderation, 454048
        • Sanofi-Aventis Investigational Site Number 643040
      • Chelyabinsk, Den Russiske Føderation, 454092
        • Sanofi-Aventis Investigational Site Number 643050
      • Chelyabinsk, Den Russiske Føderation, 454136
        • Sanofi-Aventis Investigational Site Number 643036
      • Ekaterinburg, Den Russiske Føderation, 620109
        • Sanofi-Aventis Investigational Site Number 643031
      • Kemerovo, Den Russiske Føderation, 650002
        • Sanofi-Aventis Investigational Site Number 643009
      • Kemerovo, Den Russiske Føderation, 650002
        • Sanofi-Aventis Investigational Site Number 643042
      • Moscow, Den Russiske Føderation, 105066
        • Sanofi-Aventis Investigational Site Number 643015
      • Moscow, Den Russiske Føderation, 109263
        • Sanofi-Aventis Investigational Site Number 643032
      • Moscow, Den Russiske Føderation, 111539
        • Sanofi-Aventis Investigational Site Number 643007
      • Moscow, Den Russiske Føderation, 117292
        • Sanofi-Aventis Investigational Site Number 643020
      • Moscow, Den Russiske Føderation, 117342
        • Sanofi-Aventis Investigational Site Number 643054
      • Moscow, Den Russiske Føderation, 117556
        • Sanofi-Aventis Investigational Site Number 643052
      • Moscow, Den Russiske Føderation, 119415
        • Sanofi-Aventis Investigational Site Number 643056
      • Moscow, Den Russiske Føderation, 119435
        • Sanofi-Aventis Investigational Site Number 643025
      • Moscow, Den Russiske Føderation, 119435
        • Sanofi-Aventis Investigational Site Number 643053
      • Moscow, Den Russiske Føderation, 121359
        • Sanofi-Aventis Investigational Site Number 643028
      • Moscow, Den Russiske Føderation, 121359
        • Sanofi-Aventis Investigational Site Number 643037
      • Moscow, Den Russiske Føderation, 121552
        • Sanofi-Aventis Investigational Site Number 643001
      • Moscow, Den Russiske Føderation, 121552
        • Sanofi-Aventis Investigational Site Number 643026
      • Moscow, Den Russiske Føderation, 121552
        • Sanofi-Aventis Investigational Site Number 643039
      • Moscow, Den Russiske Føderation, 127473
        • Sanofi-Aventis Investigational Site Number 643011
      • Moscow, Den Russiske Føderation, 127473
        • Sanofi-Aventis Investigational Site Number 643034
      • Moscow, Den Russiske Føderation, 129090
        • Sanofi-Aventis Investigational Site Number 643049
      • Moscow, Den Russiske Føderation, 129336
        • Sanofi-Aventis Investigational Site Number 643030
      • Nizhny Novgorod, Den Russiske Føderation, 603003
        • Sanofi-Aventis Investigational Site Number 643013
      • Nizniy Novgorod, Den Russiske Føderation, 603005
        • Sanofi-Aventis Investigational Site Number 643041
      • Novosibirsk, Den Russiske Føderation, 630008
        • Sanofi-Aventis Investigational Site Number 643051
      • Novosibirsk, Den Russiske Føderation, 630091
        • Sanofi-Aventis Investigational Site Number 643044
      • Novosibirsk-117, Den Russiske Føderation, 630117
        • Sanofi-Aventis Investigational Site Number 643048
      • Penza, Den Russiske Føderation
        • Sanofi-Aventis Investigational Site Number 643045
      • Perm, Den Russiske Føderation, 614097
        • Sanofi-Aventis Investigational Site Number 643023
      • Perm, Den Russiske Føderation, 614107
        • Sanofi-Aventis Investigational Site Number 643006
      • Petrozavodsk, Den Russiske Føderation, 185019
        • Sanofi-Aventis Investigational Site Number 643046
      • Rostov-Na-Donu, Den Russiske Føderation, 344068
        • Sanofi-Aventis Investigational Site Number 643012
      • Ryazan, Den Russiske Føderation, 390026
        • Sanofi-Aventis Investigational Site Number 643008
      • Saint-Petersburg, Den Russiske Føderation, 197022
        • Sanofi-Aventis Investigational Site Number 643017
      • Saint-Petersburg, Den Russiske Føderation, 197022
        • Sanofi-Aventis Investigational Site Number 643047
      • Samara, Den Russiske Føderation, 443070
        • Sanofi-Aventis Investigational Site Number 643029
      • Saratov, Den Russiske Føderation, 410028
        • Sanofi-Aventis Investigational Site Number 643004
      • Saratov, Den Russiske Føderation, 410028
        • Sanofi-Aventis Investigational Site Number 643005
      • Saratov, Den Russiske Føderation, 410054
        • Sanofi-Aventis Investigational Site Number 643003
      • St-Petersburg, Den Russiske Føderation, 192242
        • Sanofi-Aventis Investigational Site Number 643022
      • St-Petersburg, Den Russiske Føderation, 194354
        • Sanofi-Aventis Investigational Site Number 643038
      • St-Petersburg, Den Russiske Føderation, 196247
        • Sanofi-Aventis Investigational Site Number 643016
      • St-Petersburg, Den Russiske Føderation, 197110
        • Sanofi-Aventis Investigational Site Number 643018
      • St-Petersburg, Den Russiske Føderation, 198013
        • Sanofi-Aventis Investigational Site Number 643010
      • St-Petersburg, Den Russiske Føderation, 198013
        • Sanofi-Aventis Investigational Site Number 643027
      • St-Petersburg, Den Russiske Føderation, 199106
        • Sanofi-Aventis Investigational Site Number 643002
      • Tomsk, Den Russiske Føderation, 634012
        • Sanofi-Aventis Investigational Site Number 643024
      • Tomsk, Den Russiske Føderation, 634012
        • Sanofi-Aventis Investigational Site Number 643035
      • Tyumen, Den Russiske Føderation, 625023
        • Sanofi-Aventis Investigational Site Number 643021
      • Voronezh, Den Russiske Føderation, 394006
        • Sanofi-Aventis Investigational Site Number 643043
      • Yaroslavl, Den Russiske Føderation, 150062
        • Sanofi-Aventis Investigational Site Number 643019
  • Egypten
      • Alexandria, Egypten
        • Sanofi-Aventis Investigational Site Number 818002
      • Alexandria, Egypten
        • Sanofi-Aventis Investigational Site Number 818003
      • Alexandria, Egypten
        • Sanofi-Aventis Investigational Site Number 818004
      • Cairo, Egypten
        • Sanofi-Aventis Investigational Site Number 818001
  • Estland
      • Tallinn, Estland, 10138
        • Sanofi-Aventis Investigational Site Number 233003
      • Tallinn, Estland, 13415
        • Sanofi-Aventis Investigational Site Number 233004
      • Tallinn, Estland, 13419
        • Sanofi-Aventis Investigational Site Number 233001
      • Tartu, Estland, 50410
        • Sanofi-Aventis Investigational Site Number 233002
  • Filippinerne
      • Quezon City, Filippinerne, 1102
        • Sanofi-Aventis Investigational Site Number 608001
  • Finland
      • Helsinki, Finland, 00290
        • Sanofi-Aventis Investigational Site Number 246001
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Sanofi-Aventis Investigational Site Number 840227
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85723
        • Sanofi-Aventis Investigational Site Number 840209
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72204
        • Sanofi-Aventis Investigational Site Number 840255
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Sanofi-Aventis Investigational Site Number 840224
      • Mountain Home, Arkansas, Forenede Stater, 72653
        • Sanofi-Aventis Investigational Site Number 840179
    • California
      • Beverly Hills, California, Forenede Stater, 90210
        • Sanofi-Aventis Investigational Site Number 840270
      • Beverly Hills, California, Forenede Stater, 90211
        • Sanofi-Aventis Investigational Site Number 840278
      • Burbank, California, Forenede Stater, 91505
        • Sanofi-Aventis Investigational Site Number 840241
      • Corona, California, Forenede Stater, 92879
        • Sanofi-Aventis Investigational Site Number 840010
      • Encino, California, Forenede Stater, 91436
        • Sanofi-Aventis Investigational Site Number 840195
      • Loma Linda, California, Forenede Stater, 92354
        • Sanofi-Aventis Investigational Site Number 840033
      • Long Beach, California, Forenede Stater, 90813
        • Sanofi-Aventis Investigational Site Number 840184
      • Los Banos, California, Forenede Stater, 93635
        • Sanofi-Aventis Investigational Site Number 840183
      • Northridge, California, Forenede Stater, 91325
        • Sanofi-Aventis Investigational Site Number 840272
      • Orange, California, Forenede Stater, 92868
        • Sanofi-Aventis Investigational Site Number 840213
      • Redondo Beach, California, Forenede Stater, 90277
        • Sanofi-Aventis Investigational Site Number 840009
      • Riverside, California, Forenede Stater, 92501
        • Sanofi-Aventis Investigational Site Number 840298
      • San Diego, California, Forenede Stater, 92103
        • Sanofi-Aventis Investigational Site Number 840264
      • San Diego, California, Forenede Stater, 92128
        • Sanofi-Aventis Investigational Site Number 840275
      • Santa Ana, California, Forenede Stater, 92704
        • Sanofi-Aventis Investigational Site Number 840103
      • Santa Rosa, California, Forenede Stater, 95405
        • Sanofi-Aventis Investigational Site Number 840002
      • Torrance, California, Forenede Stater, 90505
        • Sanofi-Aventis Investigational Site Number 840111
      • Visalia, California, Forenede Stater, 93291
        • Sanofi-Aventis Investigational Site Number 840118
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06610
        • Sanofi-Aventis Investigational Site Number 840268
    • Florida
      • Bay Pines, Florida, Forenede Stater, 33744
        • Sanofi-Aventis Investigational Site Number 840246
      • Beach, Florida, Forenede Stater, 32168
        • Sanofi-Aventis Investigational Site Number 840066
      • Brandon, Florida, Forenede Stater, 33511
        • Sanofi-Aventis Investigational Site Number 840313
      • Dunnellon, Florida, Forenede Stater, 34432
        • Sanofi-Aventis Investigational Site Number 840084
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Sanofi-Aventis Investigational Site Number 840220
      • Ft. Lauderdale, Florida, Forenede Stater, 33308
        • Sanofi-Aventis Investigational Site Number 840138
      • Gainesville, Florida, Forenede Stater, 32608
        • Sanofi-Aventis Investigational Site Number 840215
      • Hollywood, Florida, Forenede Stater, 33021
        • Sanofi-Aventis Investigational Site Number 840131
      • Hollywood, Florida, Forenede Stater, 33021
        • Sanofi-Aventis Investigational Site Number 840161
      • Key West, Florida, Forenede Stater, 33040
        • Sanofi-Aventis Investigational Site Number 840234
      • Lake Mary, Florida, Forenede Stater, 32746
        • Sanofi-Aventis Investigational Site Number 840112
      • Lakeland, Florida, Forenede Stater, 33805
        • Sanofi-Aventis Investigational Site Number 840053
      • Melbourne, Florida, Forenede Stater, 32901
        • Sanofi-Aventis Investigational Site Number 840198
      • Miami, Florida, Forenede Stater, 33156
        • Sanofi-Aventis Investigational Site Number 840117
      • Niceville, Florida, Forenede Stater, 32578
        • Sanofi-Aventis Investigational Site Number 840003
      • Ocala, Florida, Forenede Stater, 34471
        • Sanofi-Aventis Investigational Site Number 840230
      • Orlando, Florida, Forenede Stater, 32803
        • Sanofi-Aventis Investigational Site Number 840202
      • Orlando, Florida, Forenede Stater, 32822
        • Sanofi-Aventis Investigational Site Number 840306
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Sanofi-Aventis Investigational Site Number 840022
      • Palm Harbor, Florida, Forenede Stater, 34684
        • Sanofi-Aventis Investigational Site Number 840110
      • Plantation, Florida, Forenede Stater, 33317
        • Sanofi-Aventis Investigational Site Number 840211
      • Sanford, Florida, Forenede Stater, 32271
        • Sanofi-Aventis Investigational Site Number 840116
      • Spring Hill, Florida, Forenede Stater, 34609
        • Sanofi-Aventis Investigational Site Number 840243
      • St. Petersburg, Florida, Forenede Stater, 33701
        • Sanofi-Aventis Investigational Site Number 840082
      • St. Petersburg, Florida, Forenede Stater, 33707
        • Sanofi-Aventis Investigational Site Number 840012
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Sanofi-Aventis Investigational Site Number 840073
      • Augusta, Georgia, Forenede Stater, 30909
        • Sanofi-Aventis Investigational Site Number 840273
      • Columbus, Georgia, Forenede Stater, 31904-5245
        • Sanofi-Aventis Investigational Site Number 840204
      • Columbus, Georgia, Forenede Stater, 31904
        • Sanofi-Aventis Investigational Site Number 840290
      • Columbus, Georgia, Forenede Stater, 31907
        • Sanofi-Aventis Investigational Site Number 840225
      • Dunwoody, Georgia, Forenede Stater, 30338
        • Sanofi-Aventis Investigational Site Number 840305
      • Savannah, Georgia, Forenede Stater, 31405
        • Sanofi-Aventis Investigational Site Number 840165
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Sanofi-Aventis Investigational Site Number 840130
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Sanofi-Aventis Investigational Site Number 840228
      • Nampa, Idaho, Forenede Stater, 83686
        • Sanofi-Aventis Investigational Site Number 840143
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Sanofi-Aventis Investigational Site Number 840221
      • Chicago, Illinois, Forenede Stater, 60664
        • Sanofi-Aventis Investigational Site Number 840206
    • Indiana
      • Beaver, Indiana, Forenede Stater, 15009
        • Sanofi-Aventis Investigational Site Number 840280
      • Elkhart, Indiana, Forenede Stater, 46514
        • Sanofi-Aventis Investigational Site Number 840014
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67208
        • Sanofi-Aventis Investigational Site Number 840249
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40504
        • Sanofi-Aventis Investigational Site Number 840265
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, SUITE 250
        • Sanofi-Aventis Investigational Site Number 840047
      • Jena, Louisiana, Forenede Stater, 71342
        • Sanofi-Aventis Investigational Site Number 840218
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Sanofi-Aventis Investigational Site Number 840247
      • Lake Charles, Louisiana, Forenede Stater, 70601
        • Sanofi-Aventis Investigational Site Number 840158
      • Natchitoches, Louisiana, Forenede Stater, 71457
        • Sanofi-Aventis Investigational Site Number 840077
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Sanofi-Aventis Investigational Site Number 840259
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Sanofi-Aventis Investigational Site Number 840231
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Sanofi-Aventis Investigational Site Number 840232
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • Sanofi-Aventis Investigational Site Number 840145
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21237
        • Sanofi-Aventis Investigational Site Number 840017
      • Denton, Maryland, Forenede Stater, 76201
        • Sanofi-Aventis Investigational Site Number 840317
    • Michigan
      • Alpena, Michigan, Forenede Stater, 49707
        • Sanofi-Aventis Investigational Site Number 840311
      • Brighton, Michigan, Forenede Stater, 48114
        • Sanofi-Aventis Investigational Site Number 840276
      • Detroit, Michigan, Forenede Stater, 48236
        • Sanofi-Aventis Investigational Site Number 840242
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Sanofi-Aventis Investigational Site Number 840253
      • St. Clair Shores, Michigan, Forenede Stater, 48081
        • Sanofi-Aventis Investigational Site Number 840137
    • Minnesota
      • St Cloud, Minnesota, Forenede Stater, 56303
        • Sanofi-Aventis Investigational Site Number 840134
    • Mississippi
      • Gulfport, Mississippi, Forenede Stater, 39503
        • Sanofi-Aventis Investigational Site Number 840067
      • Picayune, Mississippi, Forenede Stater, 39466
        • Sanofi-Aventis Investigational Site Number 840006
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63104
        • Sanofi-Aventis Investigational Site Number 840201
      • St. Louis, Missouri, Forenede Stater, 63122
        • Sanofi-Aventis Investigational Site Number 840310
      • St. Louis, Missouri, Forenede Stater, 63128
        • Sanofi-Aventis Investigational Site Number 840200
      • St. Louis, Missouri, Forenede Stater, 63141
        • Sanofi-Aventis Investigational Site Number 840323
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Sanofi-Aventis Investigational Site Number 840096
      • Butte, Montana, Forenede Stater, 59701
        • Sanofi-Aventis Investigational Site Number 840008
    • Nebraska
      • Fremont, Nebraska, Forenede Stater, 68025
        • Sanofi-Aventis Investigational Site Number 840126
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Sanofi-Aventis Investigational Site Number 840051
      • Las Vegas, Nevada, Forenede Stater, 89144
        • Sanofi-Aventis Investigational Site Number 840258
    • New Jersey
      • Hamilton, New Jersey, Forenede Stater, 08690
        • Sanofi-Aventis Investigational Site Number 840303
      • Linden, New Jersey, Forenede Stater, 07036
        • Sanofi-Aventis Investigational Site Number 840109
      • Morristown, New Jersey, Forenede Stater, 07962-1956
        • Sanofi-Aventis Investigational Site Number 840024
    • New York
      • Bronx, New York, Forenede Stater
        • Sanofi-Aventis Investigational Site Number 840284
      • Buffalo, New York, Forenede Stater, 14209
        • Sanofi-Aventis Investigational Site Number 840102
      • Johnson City, New York, Forenede Stater, 13790
        • Sanofi-Aventis Investigational Site Number 840152
      • Rochester, New York, Forenede Stater, 14607
        • Sanofi-Aventis Investigational Site Number 840159
      • Westfield, New York, Forenede Stater, 14787
        • Sanofi-Aventis Investigational Site Number 840056
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Sanofi-Aventis Investigational Site Number 840277
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Sanofi-Aventis Investigational Site Number 840196
      • Hickory, North Carolina, Forenede Stater, 28602
        • Sanofi-Aventis Investigational Site Number 840127
      • Raleigh, North Carolina, Forenede Stater, 27615
        • Sanofi-Aventis Investigational Site Number 840150
      • Rocky Mount, North Carolina, Forenede Stater, 27804
        • Sanofi-Aventis Investigational Site Number 840185
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
        • Sanofi-Aventis Investigational Site Number 840020
    • Ohio
      • Centerville, Ohio, Forenede Stater, 45459
        • Sanofi-Aventis Investigational Site Number 840197
      • Cincinnati, Ohio, Forenede Stater, 45267-0525
        • Sanofi-Aventis Investigational Site Number 840074
      • Cleveland, Ohio, Forenede Stater, 44109
        • Sanofi-Aventis Investigational Site Number 840146
      • Gallipolis, Ohio, Forenede Stater, 45631
        • Sanofi-Aventis Investigational Site Number 840292
      • Mason, Ohio, Forenede Stater, 45040
        • Sanofi-Aventis Investigational Site Number 840026
      • Toledo, Ohio, Forenede Stater, 43608
        • Sanofi-Aventis Investigational Site Number 840233
      • Wadsworth, Ohio, Forenede Stater, 44281
        • Sanofi-Aventis Investigational Site Number 840064
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Sanofi-Aventis Investigational Site Number 840045
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Sanofi-Aventis Investigational Site Number 840133
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Sanofi-Aventis Investigational Site Number 840113
      • Portland, Oregon, Forenede Stater, 97220
        • Sanofi-Aventis Investigational Site Number 840257
    • Pennsylvania
      • Indiana, Pennsylvania, Forenede Stater, 15701
        • Sanofi-Aventis Investigational Site Number 840304
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • Sanofi-Aventis Investigational Site Number 840128
      • Philadelphia, Pennsylvania, Forenede Stater, 19143
        • Sanofi-Aventis Investigational Site Number 840160
      • Philadelphia, Pennsylvania, Forenede Stater, 19149
        • Sanofi-Aventis Investigational Site Number 840339
      • Pittsburgh, Pennsylvania, Forenede Stater, 15240
        • Sanofi-Aventis Investigational Site Number 840181
      • Scotland, Pennsylvania, Forenede Stater, 17254
        • Sanofi-Aventis Investigational Site Number 840229
      • Stoneboro, Pennsylvania, Forenede Stater, 16153
        • Sanofi-Aventis Investigational Site Number 840072
    • Rhode Island
      • Cranston, Rhode Island, Forenede Stater, 02920
        • Sanofi-Aventis Investigational Site Number 840248
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • Sanofi-Aventis Investigational Site Number 840261
      • Anderson, South Carolina, Forenede Stater, 29621
        • Sanofi-Aventis Investigational Site Number 840297
      • Camden, South Carolina, Forenede Stater, 29020
        • Sanofi-Aventis Investigational Site Number 840172
      • Columbia, South Carolina, Forenede Stater, 29201
        • Sanofi-Aventis Investigational Site Number 840168
      • Manning, South Carolina, Forenede Stater, 29102
        • Sanofi-Aventis Investigational Site Number 840122
      • Newberry, South Carolina, Forenede Stater, 29108
        • Sanofi-Aventis Investigational Site Number 840085
      • Pelzer, South Carolina, Forenede Stater, 29669
        • Sanofi-Aventis Investigational Site Number 840189
    • South Dakota
      • Fort Meade, South Dakota, Forenede Stater, 57741
        • Sanofi-Aventis Investigational Site Number 840032
    • Tennessee
      • Athens, Tennessee, Forenede Stater, 37303
        • Sanofi-Aventis Investigational Site Number 840062
      • Bristol, Tennessee, Forenede Stater, 37620
        • Sanofi-Aventis Investigational Site Number 840048
      • Bristol, Tennessee, Forenede Stater, 37620
        • Sanofi-Aventis Investigational Site Number 840052
      • Cleveland, Tennessee, Forenede Stater, 37312
        • Sanofi-Aventis Investigational Site Number 840104
      • Johnson City, Tennessee, Forenede Stater, 37614
        • Sanofi-Aventis Investigational Site Number 840129
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sanofi-Aventis Investigational Site Number 840269
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Sanofi-Aventis Investigational Site Number 840076
      • Corsicana, Texas, Forenede Stater, 75110
        • Sanofi-Aventis Investigational Site Number 840252
      • Houston, Texas, Forenede Stater, 77070
        • Sanofi-Aventis Investigational Site Number 840286
      • Irving, Texas, Forenede Stater, 75061
        • Sanofi-Aventis Investigational Site Number 840132
      • Odessa, Texas, Forenede Stater, 79761
        • Sanofi-Aventis Investigational Site Number 840005
      • Odessa, Texas, Forenede Stater, 79761
        • Sanofi-Aventis Investigational Site Number 840289
      • San Antonio, Texas, Forenede Stater, 78234
        • Sanofi-Aventis Investigational Site Number 840186
      • San Antonio, Texas, Forenede Stater, 78238
        • Sanofi-Aventis Investigational Site Number 840194
      • Temple, Texas, Forenede Stater, 76508
        • Sanofi-Aventis Investigational Site Number 840236
      • Victoria, Texas, Forenede Stater, 77901
        • Sanofi-Aventis Investigational Site Number 840011
      • Wichita Falls, Texas, Forenede Stater, 76309
        • Sanofi-Aventis Investigational Site Number 840285
    • Utah
      • Clinton, Utah, Forenede Stater, 84015
        • Sanofi-Aventis Investigational Site Number 840223
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Sanofi-Aventis Investigational Site Number 840238
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Sanofi-Aventis Investigational Site Number 840308
    • Virginia
      • Salem, Virginia, Forenede Stater, 24153
        • Sanofi-Aventis Investigational Site Number 840068
      • Springfield, Virginia, Forenede Stater, 22151
        • Sanofi-Aventis Investigational Site Number 840219
    • Washington
      • Everett, Washington, Forenede Stater, 98201
        • Sanofi-Aventis Investigational Site Number 840058
      • Seattle, Washington, Forenede Stater, 98111
        • Sanofi-Aventis Investigational Site Number 840123
      • Tacoma, Washington, Forenede Stater, 98405
        • Sanofi-Aventis Investigational Site Number 840019
    • Wisconsin
      • Beloit, Wisconsin, Forenede Stater, 53511
        • Sanofi-Aventis Investigational Site Number 840256
      • Madison, Wisconsin, Forenede Stater, 53713
        • Sanofi-Aventis Investigational Site Number 840293
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Sanofi-Aventis Investigational Site Number 840282
  • Frankrig
      • Abbeville, Frankrig, 80142
        • Sanofi-Aventis Investigational Site Number 250028
      • Albi Cedex 9, Frankrig, 81013
        • Sanofi-Aventis Investigational Site Number 250012
      • Allauch, Frankrig, 13190
        • Sanofi-Aventis Investigational Site Number 250034
      • Belfort Cedex, Frankrig, 90016
        • Sanofi-Aventis Investigational Site Number 250031
      • Bordeaux, Frankrig, 33076
        • Sanofi-Aventis Investigational Site Number 250011
      • Brest, Frankrig, 29609
        • Sanofi-Aventis Investigational Site Number 250021
      • Brest Cedex 2, Frankrig, 29609
        • Sanofi-Aventis Investigational Site Number 250010
      • Bron, Frankrig, 69677
        • Sanofi-Aventis Investigational Site Number 250035
      • Cholet Cedex, Frankrig, 49300
        • Sanofi-Aventis Investigational Site Number 250022
      • Dijon, Frankrig, 21033
        • Sanofi-Aventis Investigational Site Number 250006
      • Dijon Cedex, Frankrig, 21034
        • Sanofi-Aventis Investigational Site Number 250018
      • La Rochelle, Frankrig, 17019
        • Sanofi-Aventis Investigational Site Number 250004
      • Le Chesnay Cedex, Frankrig, 78187
        • Sanofi-Aventis Investigational Site Number 250029
      • Lille, Frankrig, 59020
        • Sanofi-Aventis Investigational Site Number 250019
      • Lille, Frankrig, 59037
        • Sanofi-Aventis Investigational Site Number 250015
      • Metz Tessy, Frankrig, 74370
        • Sanofi-Aventis Investigational Site Number 250030
      • Montpellier, Frankrig, 34295
        • Sanofi-Aventis Investigational Site Number 250003
      • Montpellier, Frankrig, 59523
        • Sanofi-Aventis Investigational Site Number 250032
      • Nice Cedex, Frankrig, 06006
        • Sanofi-Aventis Investigational Site Number 250016
      • Paris, Frankrig, 75018
        • Sanofi-Aventis Investigational Site Number 250001
      • Paris Cedex 13, Frankrig, 75651
        • Sanofi-Aventis Investigational Site Number 250014
      • Paris Cedex 14, Frankrig, 75674
        • Sanofi-Aventis Investigational Site Number 250008
      • Saint Etienne Cedex 2, Frankrig, 42055
        • Sanofi-Aventis Investigational Site Number 250005
      • Toulouse Cedex 9, Frankrig, 31059
        • Sanofi-Aventis Investigational Site Number 250026
      • Tours Cedex 1, Frankrig, 37044
        • Sanofi-Aventis Investigational Site Number 250027
      • Vandoeuvre Les Nancy Cedex, Frankrig, 54511
        • Sanofi-Aventis Investigational Site Number 250002
  • Grækenland
      • Athens, Grækenland, 11521
        • Sanofi-Aventis Investigational Site Number 300009
      • Athens, Grækenland, 11527
        • Sanofi-Aventis Investigational Site Number 300007
      • Athens, Grækenland, 11538
        • Sanofi-Aventis Investigational Site Number 300002
      • Athens, Grækenland
        • Sanofi-Aventis Investigational Site Number 300005
      • Chalkida, Grækenland, 34 100
        • Sanofi-Aventis Investigational Site Number 300006
      • Chios, Grækenland
        • Sanofi-Aventis Investigational Site Number 300004
      • Elefsina, Grækenland, 19600
        • Sanofi-Aventis Investigational Site Number 300008
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Sanofi-Aventis Investigational Site Number 320002
      • Guatemala, Guatemala, 01014
        • Sanofi-Aventis Investigational Site Number 320001
      • Guatemala, Guatemala, 01014
        • Sanofi-Aventis Investigational Site Number 320003
      • Guatemala, Guatemala
        • Sanofi-Aventis Investigational Site Number 320004
  • Holland
      • Almelo, Holland, 7609 PP
        • Sanofi-Aventis Investigational Site Number 528012
      • Amsterdam, Holland, 1066 EC
        • Sanofi-Aventis Investigational Site Number 528030
      • Breda, Holland, 4818 CK
        • Sanofi-Aventis Investigational Site Number 528026
      • Delft, Holland, 2526 AD
        • Sanofi-Aventis Investigational Site Number 528009
      • Den Haag, Holland, 2545 CH
        • Sanofi-Aventis Investigational Site Number 528035
      • Ede, Holland, 6716 RP
        • Sanofi-Aventis Investigational Site Number 528027
      • Eindhoven, Holland, 5623 EJ
        • Sanofi-Aventis Investigational Site Number 528006
      • Eindhoven, Holland, 5623 EJ
        • Sanofi-Aventis Investigational Site Number 528017
      • Gouda, Holland, 2803 HH
        • Sanofi-Aventis Investigational Site Number 528016
      • Harderwijk, Holland, 3844 DG
        • Sanofi-Aventis Investigational Site Number 528007
      • Heerlen, Holland, 6419 PC
        • Sanofi-Aventis Investigational Site Number 528001
      • Heerlen, Holland, 6419 PC
        • Sanofi-Aventis Investigational Site Number 528024
      • Hengelo, Holland, 7555 DL
        • Sanofi-Aventis Investigational Site Number 528003
      • Hengelo, Holland, 7555 DL
        • Sanofi-Aventis Investigational Site Number 528010
      • Hoogeveen, Holland, 7909 AA
        • Sanofi-Aventis Investigational Site Number 528031
      • Hoorn, Holland, 1625 HV
        • Sanofi-Aventis Investigational Site Number 528019
      • Leeuwarden, Holland, 8934 AD
        • Sanofi-Aventis Investigational Site Number 528020
      • Nijmegen, Holland, 6532 SZ
        • Sanofi-Aventis Investigational Site Number 528004
      • Rotterdam, Holland, 3083 AN
        • Sanofi-Aventis Investigational Site Number 528013
      • Sittard-Geleen, Holland, 6162 BG
        • Sanofi-Aventis Investigational Site Number 528022
      • Sneek, Holland, 8601 ZK
        • Sanofi-Aventis Investigational Site Number 528002
      • Tilburg, Holland, 5022 GC
        • Sanofi-Aventis Investigational Site Number 528033
      • Venlo, Holland, 5912 BL
        • Sanofi-Aventis Investigational Site Number 528021
      • Zoetermeer, Holland, 2725 NA
        • Sanofi-Aventis Investigational Site Number 528005
      • Zwolle, Holland, 8011 JW
        • Sanofi-Aventis Investigational Site Number 528025
  • Hviderusland
      • Minsk, Hviderusland, 220013
        • Sanofi-Aventis Investigational Site Number 112001
      • Minsk, Hviderusland, 220116
        • Sanofi-Aventis Investigational Site Number 112002
      • Minsk, Hviderusland, 220116
        • Sanofi-Aventis Investigational Site Number 112003
      • Minsk, Hviderusland, 220600
        • Sanofi-Aventis Investigational Site Number 112005
  • Indien
      • Ahmedabad, Indien, 380 015
        • Sanofi-Aventis Investigational Site Number 356001
      • Ahmedabad, Indien, 380054
        • Sanofi-Aventis Investigational Site Number 356010
      • Bangalore, Indien, 560034
        • Sanofi-Aventis Investigational Site Number 356015
      • Bangalore, Indien, 562 150
        • Sanofi-Aventis Investigational Site Number 356009
      • Chennai, Indien, 600 037
        • Sanofi-Aventis Investigational Site Number 356005
      • Coimbatore, Indien, 641004
        • Sanofi-Aventis Investigational Site Number 356002
      • Coimbatore, Indien, 641014
        • Sanofi-Aventis Investigational Site Number 356007
      • Lucknow, Indien, 226003
        • Sanofi-Aventis Investigational Site Number 356013
      • Lucknow, Indien, 226014
        • Sanofi-Aventis Investigational Site Number 356006
      • Mumbai, Indien, 54
        • Sanofi-Aventis Investigational Site Number 356017
      • Mysore, Indien, 570020
        • Sanofi-Aventis Investigational Site Number 356014
      • Nashik, Indien, 42003
        • Sanofi-Aventis Investigational Site Number 356020
      • New Delhi, Indien, 110060
        • Sanofi-Aventis Investigational Site Number 356004
      • New Delhi, Indien
        • Sanofi-Aventis Investigational Site Number 356012
      • Pune, Indien, 411004
        • Sanofi-Aventis Investigational Site Number 356011
      • Pune., Indien, 400011
        • Sanofi-Aventis Investigational Site Number 356018
      • Secunderabad, Indien, 500 003
        • Sanofi-Aventis Investigational Site Number 356003
  • Indonesien
      • Jakarta, Indonesien, 10430
        • Sanofi-Aventis Investigational Site Number 360002
      • Jakarta, Indonesien
        • Sanofi-Aventis Investigational Site Number 360001
  • Israel
      • Afula, Israel, 18101
        • Sanofi-Aventis Investigational Site Number 376003
      • Ashkelon, Israel, 78278
        • Sanofi-Aventis Investigational Site Number 376015
      • Givatayim, Israel, 53583
        • Sanofi-Aventis Investigational Site Number 376001
      • Haifa, Israel, 31048
        • Sanofi-Aventis Investigational Site Number 376007
      • Haifa, Israel, 31096
        • Sanofi-Aventis Investigational Site Number 376014
      • Holon, Israel, 58100
        • Sanofi-Aventis Investigational Site Number 376004
      • Nahariya, Israel, 22100
        • Sanofi-Aventis Investigational Site Number 376012
      • Nazareth, Israel, 16100
        • Sanofi-Aventis Investigational Site Number 376009
      • Rehovot, Israel, 76100
        • Sanofi-Aventis Investigational Site Number 376011
      • Tel Aviv, Israel, 64239
        • Sanofi-Aventis Investigational Site Number 376002
  • Italien
      • Ascoli Piceno, Italien, 63100
        • Sanofi-Aventis Investigational Site Number 380015
      • Borgo San Lorenzo, Italien, 50032
        • Sanofi-Aventis Investigational Site Number 380018
      • Chieti, Italien, 66013
        • Sanofi-Aventis Investigational Site Number 380016
      • Fidenza, Italien, 43036
        • Sanofi-Aventis Investigational Site Number 380005
      • Merate, Italien, 23807
        • Sanofi-Aventis Investigational Site Number 380010
      • Milano, Italien, 20132
        • Sanofi-Aventis Investigational Site Number 380014
      • Novara, Italien, 28100
        • Sanofi-Aventis Investigational Site Number 380020
      • Padova, Italien, 35128
        • Sanofi-Aventis Investigational Site Number 380001
      • Padova, Italien, 35128
        • Sanofi-Aventis Investigational Site Number 380007
      • Palermo, Italien, 90127
        • Sanofi-Aventis Investigational Site Number 380004
      • Pavia, Italien, 27100
        • Sanofi-Aventis Investigational Site Number 380008
      • Perugia, Italien, 06132
        • Sanofi-Aventis Investigational Site Number 380021
      • San Daniele Del Friuli, Italien, 33038
        • Sanofi-Aventis Investigational Site Number 380013
      • Sassari, Italien, 07100
        • Sanofi-Aventis Investigational Site Number 380003
      • Torino, Italien, 10144
        • Sanofi-Aventis Investigational Site Number 380011
      • Treviso, Italien, 31100
        • Sanofi-Aventis Investigational Site Number 380009
  • Kalkun
      • Edirne, Kalkun
        • Sanofi-Aventis Investigational Site Number 792004
      • Edirne, Kalkun
        • Sanofi-Aventis Investigational Site Number 792005
      • Istanbul, Kalkun, 34034
        • Sanofi-Aventis Investigational Site Number 792002
      • Istanbul, Kalkun
        • Sanofi-Aventis Investigational Site Number 792001
      • Istanbul, Kalkun
        • Sanofi-Aventis Investigational Site Number 792003
      • Kocaeli, Kalkun, 41300
        • Sanofi-Aventis Investigational Site Number 792006
      • Kocaeli, Kalkun, 41380
        • Sanofi-Aventis Investigational Site Number 792007
  • Korea, Republikken
      • Anyang, Korea, Republikken, 431-070
        • Sanofi-Aventis Investigational Site Number 410008
      • Daegu, Korea, Republikken, 700-712
        • Sanofi-Aventis Investigational Site Number 410002
      • Goyang, Korea, Republikken, 411-706
        • Sanofi-Aventis Investigational Site Number 410006
      • Goyang, Korea, Republikken, 411-773
        • Sanofi-Aventis Investigational Site Number 410012
      • Gwangju, Korea, Republikken, 501-757
        • Sanofi-Aventis Investigational Site Number 410007
      • Seongnam, Korea, Republikken, 463-802
        • Sanofi-Aventis Investigational Site Number 410003
      • Seoul, Korea, Republikken, 134-701
        • Sanofi-Aventis Investigational Site Number 410001
      • Seoul, Korea, Republikken, 135-710
        • Sanofi-Aventis Investigational Site Number 410004
      • Seoul, Korea, Republikken, 138-736
        • Sanofi-Aventis Investigational Site Number 410005
      • Seoul, Korea, Republikken, 140-210
        • Sanofi-Aventis Investigational Site Number 410011
  • Kroatien
      • Split, Kroatien, 21000
        • Sanofi-Aventis Investigational Site Number 191003
      • Zagreb, Kroatien, 10000
        • Sanofi-Aventis Investigational Site Number 191001
      • Zagreb, Kroatien, 10000
        • Sanofi-Aventis Investigational Site Number 191004
  • Litauen
      • Kaunas, Litauen, 3007
        • Sanofi-Aventis Investigational Site Number 440004
      • Kaunas, Litauen, LT-49456
        • Sanofi-Aventis Investigational Site Number 440002
      • Vilnius, Litauen, LT-07156
        • Sanofi-Aventis Investigational Site Number 440003
      • Vilnius, Litauen, LT-08661
        • Sanofi-Aventis Investigational Site Number 440001
  • Malaysia
      • Kuching, Malaysia, 93586
        • Sanofi-Aventis Investigational Site Number 458001
      • Penang, Malaysia, 10450
        • Sanofi-Aventis Investigational Site Number 458002
      • Taiping, Malaysia, 34000
        • Sanofi-Aventis Investigational Site Number 458005
  • Marokko
      • Marrakech, Marokko, 40000
        • Sanofi-Aventis Investigational Site Number 504001
      • Meknes, Marokko, 50000
        • Sanofi-Aventis Investigational Site Number 504002
  • Mexico
      • Acapulco, Mexico, 39670
        • Sanofi-Aventis Investigational Site Number 484008
      • Aguascalientes, Mexico, 20230
        • Sanofi-Aventis Investigational Site Number 484013
      • Aguascalientes, Mexico, 20230
        • Sanofi-Aventis Investigational Site Number 484016
      • Guadalajara, Mexico, 4428
        • Sanofi-Aventis Investigational Site Number 484004
      • Guadalajara, Mexico, 44340
        • Sanofi-Aventis Investigational Site Number 484007
      • Mexico Df, Mexico, 07300
        • Sanofi-Aventis Investigational Site Number 484012
      • Monterrey, Mexico, 64060
        • Sanofi-Aventis Investigational Site Number 484010
      • San Luis Potosi, Mexico, 72244
        • Sanofi-Aventis Investigational Site Number 484011
      • San Luis Potosi, Mexico, 78200
        • Sanofi-Aventis Investigational Site Number 484005
      • Veracruz, Mexico, 91700
        • Sanofi-Aventis Investigational Site Number 484003
  • New Zealand
      • Christchurch, New Zealand
        • Sanofi-Aventis Investigational Site Number 554003
      • Dunedin, New Zealand
        • Sanofi-Aventis Investigational Site Number 554002
      • Nelson, New Zealand
        • Sanofi-Aventis Investigational Site Number 554001
  • Norge
      • Bergen, Norge, 5021
        • Sanofi-Aventis Investigational Site Number 578001
      • Flekkefjord, Norge, 4400
        • Sanofi-Aventis Investigational Site Number 578006
      • Lørenskog, Norge, 1478
        • Sanofi-Aventis Investigational Site Number 578005
      • Oslo, Norge, 0027
        • Sanofi-Aventis Investigational Site Number 578004
  • Panama
      • Panama, Panama
        • Sanofi-Aventis Investigational Site Number 591001
      • Panama, Panama
        • Sanofi-Aventis Investigational Site Number 591002
      • Panama, Panama
        • Sanofi-Aventis Investigational Site Number 591003
  • Peru
      • Lima, Peru, CALLAO 2
        • Sanofi-Aventis Investigational Site Number 604004
      • Lima, Peru, Lima 11
        • Sanofi-Aventis Investigational Site Number 604002
      • Lima, Peru, LIMA 13
        • Sanofi-Aventis Investigational Site Number 604001
      • Lima, Peru, LIMA 31
        • Sanofi-Aventis Investigational Site Number 604005
      • Lima, Peru, LIMA 41
        • Sanofi-Aventis Investigational Site Number 604003
  • Polen
      • Chojnice, Polen, 89-600
        • Sanofi-Aventis Investigational Site Number 616013
      • Gdansk, Polen, 81-756
        • Sanofi-Aventis Investigational Site Number 616011
      • Gdynia-Redlowo, Polen, 81-402
        • Sanofi-Aventis Investigational Site Number 616014
      • Katowice, Polen, 40-635
        • Sanofi-Aventis Investigational Site Number 616009
      • Lodz, Polen, 91-425
        • Sanofi-Aventis Investigational Site Number 616017
      • Lublin, Polen, 20-954
        • Sanofi-Aventis Investigational Site Number 616002
      • Ostrowiec Swietokrzyski, Polen, 27-400
        • Sanofi-Aventis Investigational Site Number 616012
      • Pulawy, Polen, 24-100
        • Sanofi-Aventis Investigational Site Number 616015
      • Torun, Polen, 87-100
        • Sanofi-Aventis Investigational Site Number 616007
      • Tychy, Polen, 43-100
        • Sanofi-Aventis Investigational Site Number 616006
      • Warszawa, Polen, 02-005
        • Sanofi-Aventis Investigational Site Number 616001
      • Warszawa, Polen, 02-097
        • Sanofi-Aventis Investigational Site Number 616010
      • Wroclaw, Polen, 50-349
        • Sanofi-Aventis Investigational Site Number 616008
  • Portugal
      • Amadora, Portugal, 2720-276
        • Sanofi-Aventis Investigational Site Number 620002
      • Braga, Portugal, 4701-968
        • Sanofi-Aventis Investigational Site Number 620007
      • Coimbra, Portugal, 3000-075
        • Sanofi-Aventis Investigational Site Number 620006
      • Setubal, Portugal, 2910-446
        • Sanofi-Aventis Investigational Site Number 620008
  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
        • Sanofi-Aventis Investigational Site Number 630001
  • Slovakiet
      • Kosice, Slovakiet, 04015
        • Sanofi-Aventis Investigational Site Number 703003
      • Levice, Slovakiet
        • Sanofi-Aventis Investigational Site Number 703005
      • Nitra, Slovakiet, 950 01
        • Sanofi-Aventis Investigational Site Number 703004
      • Poprad, Slovakiet, 05845
        • Sanofi-Aventis Investigational Site Number 703006
      • Trnava, Slovakiet, 91775
        • Sanofi-Aventis Investigational Site Number 703002
  • Spanien
      • Barcelona, Spanien, 08003
        • Sanofi-Aventis Investigational Site Number 724003
      • Barcelona, Spanien, 08036
        • Sanofi-Aventis Investigational Site Number 724002
      • Madrid, Spanien, 28046
        • Sanofi-Aventis Investigational Site Number 724001
      • Santiago De Compostela, Spanien, 15706
        • Sanofi-Aventis Investigational Site Number 724005
      • Sevilla, Spanien, 41006
        • Sanofi-Aventis Investigational Site Number 724007
  • Sverige
      • Göteborg, Sverige, 413 45
        • Sanofi-Aventis Investigational Site Number 752003
      • Göteborg, Sverige, 413 45
        • Sanofi-Aventis Investigational Site Number 752006
      • Malmo, Sverige, 211 52
        • Sanofi-Aventis Investigational Site Number 752007
      • Malmö, Sverige, 20502
        • Sanofi-Aventis Investigational Site Number 752002
      • Ostersund, Sverige, 831 83
        • Sanofi-Aventis Investigational Site Number 752004
      • Stockolm, Sverige, SE-171 76
        • Sanofi-Aventis Investigational Site Number 752001
  • Sydafrika
      • Amanzimtoti, Sydafrika
        • Sanofi-Aventis Investigational Site Number 710013
      • Bloemfontein, Sydafrika
        • Sanofi-Aventis Investigational Site Number 710011
      • Cape Town, Sydafrika, 7129
        • Sanofi-Aventis Investigational Site Number 710007
      • Cape Town, Sydafrika, 7764
        • Sanofi-Aventis Investigational Site Number 710017
      • Durban, Sydafrika, 4092
        • Sanofi-Aventis Investigational Site Number 710001
      • Durban, Sydafrika
        • Sanofi-Aventis Investigational Site Number 710012
      • Johannesburg, Sydafrika, 1449
        • Sanofi-Aventis Investigational Site Number 710009
      • Port Elizabeth, Sydafrika
        • Sanofi-Aventis Investigational Site Number 710016
      • Pretoria, Sydafrika, 0084
        • Sanofi-Aventis Investigational Site Number 710003
      • Pretoria, Sydafrika, 0050
        • Sanofi-Aventis Investigational Site Number 710020
      • Pretoria, Sydafrika, 0204
        • Sanofi-Aventis Investigational Site Number 710002
      • Randburg, Sydafrika, 2194
        • Sanofi-Aventis Investigational Site Number 710015
      • Scottburgh, Sydafrika
        • Sanofi-Aventis Investigational Site Number 710014
      • Umhlanga Rocks, Sydafrika, 4400
        • Sanofi-Aventis Investigational Site Number 710018
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Sanofi-Aventis Investigational Site Number 158003
      • Taichung, Taiwan
        • Sanofi-Aventis Investigational Site Number 158002
      • Tainan Hsien, Taiwan, 710
        • Sanofi-Aventis Investigational Site Number 158004
      • Taipei, Taiwan
        • Sanofi-Aventis Investigational Site Number 158001
      • Taipei, Taiwan
        • Sanofi-Aventis Investigational Site Number 158005
  • Thailand
      • Bangkok, Thailand, 10330
        • Sanofi-Aventis Investigational Site Number 764001
      • Bangkok-Noi, Thailand, 10700
        • Sanofi-Aventis Investigational Site Number 764002
      • Muang, Thailand, 50200
        • Sanofi-Aventis Investigational Site Number 764003
  • Tjekkiet
      • Chomutov, Tjekkiet, 43012
        • Sanofi-Aventis Investigational Site Number 203005
      • Jihlava, Tjekkiet, 58633
        • Sanofi-Aventis Investigational Site Number 203003
      • Ostrava Vitkovice, Tjekkiet, 70300
        • Sanofi-Aventis Investigational Site Number 203009
      • Pardubice, Tjekkiet, 53203
        • Sanofi-Aventis Investigational Site Number 203001
      • Plzen - Bory, Tjekkiet, 30599
        • Sanofi-Aventis Investigational Site Number 203011
      • Praha 2, Tjekkiet, 12808
        • Sanofi-Aventis Investigational Site Number 203002
      • Praha 4, Tjekkiet, 14059
        • Sanofi-Aventis Investigational Site Number 203004
      • Praha 6, Tjekkiet, 16902
        • Sanofi-Aventis Investigational Site Number 203010
      • Prostejov, Tjekkiet, 796 04
        • Sanofi-Aventis Investigational Site Number 203006
      • Usti Nad Orlici, Tjekkiet, 56218
        • Sanofi-Aventis Investigational Site Number 203008
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804013
      • Dnepropetrovsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804015
      • Dnipropetrovsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804005
      • Ivano-Frankivsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804008
      • Kharkiv, Ukraine
        • Sanofi-Aventis Investigational Site Number 804004
      • Kharkov, Ukraine
        • Sanofi-Aventis Investigational Site Number 804002
      • Kharkov, Ukraine
        • Sanofi-Aventis Investigational Site Number 804012
      • Kiev, Ukraine
        • Sanofi-Aventis Investigational Site Number 804003
      • Lutsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804007
      • Lutsk, Ukraine
        • Sanofi-Aventis Investigational Site Number 804009
      • Odessa, Ukraine
        • Sanofi-Aventis Investigational Site Number 804011
      • Ternopil, Ukraine
        • Sanofi-Aventis Investigational Site Number 804010
      • Uzhgorod, Ukraine
        • Sanofi-Aventis Investigational Site Number 804006
      • Zaporizhzhia, Ukraine
        • Sanofi-Aventis Investigational Site Number 804014
  • Venezuela
      • Caracas, Venezuela
        • Sanofi-Aventis Investigational Site Number 862001
      • Maracay, Venezuela, 2103
        • Sanofi-Aventis Investigational Site Number 862002
  • Østrig
      • Graz, Østrig, 8036
        • Sanofi-Aventis Investigational Site Number 040001
      • Linz, Østrig, 4021
        • Sanofi-Aventis Investigational Site Number 040004

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Ikke valvulær atrieflimren (AF)
  • Indikation for langtidsbehandling med vitamin-K-antagonist (VKA) baseret på tilstedeværelsen af ​​tidligere iskæmisk slagtilfælde, forbigående iskæmisk anfald (TIA) eller systemisk emboli og/eller mindst to af følgende risikofaktorer: hypertension, der kræver lægemiddelbehandling, moderat eller alvorligt svækket venstre ventrikelfunktion og/eller kongestiv hjertesvigt, alder > eller = 75 år, diabetes mellitus.

Vigtigste eksklusionskriterier:

  • Indikation for andre VKA end AF
  • Slagtilfælde eller TIA inden for de foregående 5 dage
  • Forbigående AF forårsaget af en reversibel lidelse
  • Planlagt større operation/traume eller kardioversion inden for 30 dage
  • INR > 3 ved baseline
  • Aktiv blødning eller høj risiko for blødning
  • Ukontrolleret hypertension
  • Graviditet eller fødedygtighed uden passende præventionsforanstaltninger eller amning.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Idrabiotaparinux

Idrabiotaparinux-natrium, 3,0 mg, én gang ugentligt i 7 uger efterfulgt af en vedligeholdelsesdosis tilpasset alderen og nyrefunktionen i en samlet minimumsbehandlingsvarighed på 6 måneder.

Avidin, 100 mg, efter investigators skøn, når det skønnes passende og muligt (dvs. livstruende blødning, akut invasiv procedure med mulighed for ukontrolleret blødning eller overdosering).
Medicin: Placebo (mod warfarin)

Warfarin matchende kapsler

Oral administration

Medicin: Idrabiotaparinux natrium

Fyldte sprøjter indeholdende:

  • 0,5 ml for 3,0 mg dosis;
  • 0,33 ml for 2,0 mg-doseringen (vedligeholdelsesdosis for deltagere med let nedsat nyrefunktion og under 75 år);
  • 0,25 ml for 1,5 mg-dosis (vedligeholdelsesdosis til deltagere med moderat nedsat nyrefunktion eller alder ≥75 år).

Subkutan injektion

Andre navne:
  • SSR126517
  • Biotinyleret idraparinux
Medicin: Avidin

Hætteglas indeholdende 105 mg frysetørret pulver til fortynding

Intravenøs infusion i 30 minutter

Andre navne:
  • SSR29261
Aktiv komparator: Warfarin
Warfarin, INR-justeret dosis, i en samlet minimum behandlingsvarighed på 6 måneder.
Medicin: Warfarin

Kapsler med 1 eller 5 mg til INR-justeret dosis (INR kontrolleres mindst én gang om måneden)

Oral administration

Medicin: Placebo (til idrabiotaparinux)

Matchende fyldte sprøjter indeholdende:

  • 0,5 ml for 3,0 mg dosis;
  • 0,33 ml for 2,0 mg-doseringen (vedligeholdelsesdosis for deltagere med let nedsat nyrefunktion og under 75 år);
  • 0,25 ml for 1,5 mg-dosis (vedligeholdelsesdosis til deltagere med moderat nedsat nyrefunktion eller alder ≥75 år).

Subkutan injektion

Medicin: Placebo (til avidin)

Hætteglas indeholdende 105 mg matchende frysetørret pulver til opløsning

Intravenøs infusion i 30 minutter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sammensat af alle fatale eller ikke-dødelige slagtilfælde eller systemiske emboliske hændelser uden for centralnervesystemet (CNS) (SE)
Tidsramme: Fra randomisering til slutningen af ​​behandlingsperioden (minimum 6 måneder)
Fra randomisering til slutningen af ​​behandlingsperioden (minimum 6 måneder)

Sekundære resultatmål

Resultatmål
Tidsramme
Komponenter af det primære studieresultatmål:
Tidsramme: Fra randomisering til slutningen af ​​behandlingsperioden (minimum 6 måneder)
Fra randomisering til slutningen af ​​behandlingsperioden (minimum 6 måneder)
Sammensat af slagtilfælde eller ikke-CNS SE eller myokardieinfarkt (MI) eller venøs tromboemboli (VTE) eller større blødninger eller død
Tidsramme: Fra randomisering til slutningen af ​​behandlingsperioden (minimum 6 måneder)
Fra randomisering til slutningen af ​​behandlingsperioden (minimum 6 måneder)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

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

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. december 2007

Primær færdiggørelse (Faktiske)

1. oktober 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

21. december 2007

Først indsendt, der opfyldte QC-kriterier

21. december 2007

Først opslået (Skøn)

24. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EFC10295
  • 2007-004817-33 (EudraCT nummer)

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 .

Kliniske forsøg med Atrieflimren

Kliniske forsøg med Placebo (mod warfarin)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Costa Rica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner