- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00986154
Sammenlignende undersøgelse af Heparin/Edoxaban Tosylat (DU176b) med lav molekylvægt (LMW) versus (LMW) Heparin/Warfarin i behandlingen af symptomatiske dybveinske blodpropper og/eller lungeblodpropper. (Edoxaban Hokusai-VTE-undersøgelsen).
En fase 3, randomiseret, parallelgruppe, multicenter, multinational undersøgelse til evaluering af effektivitet og sikkerhed af (LMW) heparin/edoxaban versus (LMW) heparin/warfarin hos forsøgspersoner med symptomatisk dyb venetrombose (DVT) og eller lungeemboli (PE).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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-
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Buenos Aires, Argentina
- Investigational Site 1100
-
Buenos Aires, Argentina
- Investigational Site 1103
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Buenos Aires, Argentina
- Investigational Site 1106
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Buenos Aires, Argentina
- Investigational Site 1108
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Cordoba, Argentina
- Investigational Site 1104
-
Pcia De Corrientes, Argentina
- Investigational Site 1110
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Santa Fe, Argentina
- Investigational Site 1109
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-
-
-
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Bedford Park, Australien
- Investigational Site 4205
-
Box Hill, Australien
- Investigational Site 4209
-
Clayton, Australien
- Investigational Site 4210
-
Fremantle, Australien
- Investigational Site 4211
-
Garran, Australien
- Investigational Site 4213
-
Kogarah, Australien
-
Perth, Australien
- Investigational Site 4207
-
Redcliffe, Australien
- Investigational Site 4203
-
Saint Leonards NSW, Australien
- Investigational Site 4206
-
South Brisbane, Australien
- Investigational Site 4214
-
Westmead NSW, Australien
- Investigational Site 4212
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Windsor, Australien
- Investigational Site 4200
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-
-
-
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Aalst, Belgien
- Investigational Site 1608
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Lier, Belgien
- Investigational Site 1602
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-
-
-
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Belo Horizonte, Brasilien
- Investigational Site 2905
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Campinas, Brasilien
- Investigational Site 2914
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Curitiba, Brasilien
- Investigational Site 2901
-
Curitiba, Brasilien
- Investigational Site 2903
-
Porto Alegre, Brasilien
- Investigational Site 2912
-
Porto Alegre, Brasilien
- Investigational Site 2915
-
Porto Alegre, Brasilien
- Investigational Site 2917
-
Sao Bernardo do Campo, Brasilien
- Investigational Site 2904
-
Sao Paulo, Brasilien
- Investigational Site 2900
-
Sao Paulo, Brasilien
- Investigational Site 2902
-
Sao Paulo, Brasilien
- Investigational Site 2906
-
Sao Paulo, Brasilien
- Investigational Site 2910
-
Sao Paulo, Brasilien
- Investigational Site 2911
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-
-
-
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Halifax, Canada
- Investigational Site 2005
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Montreal, Canada
- Investigational Site 2004
-
-
Alberta
-
Edmonton, Alberta, Canada
- Investigational Site 2006
-
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Ontario
-
London, Ontario, Canada
- Investigational Site 2001
-
Newmarket, Ontario, Canada
- Investigational Site 2007
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Ottawa, Ontario, Canada
- Investigational Site 2000
-
Richmond Hill, Ontario, Canada
- Investigational Site 2003
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-
-
-
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Santiago, Chile
- Investigational Site 1200
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Santiago, Chile
- Investigational Site 1204
-
-
-
-
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Aarhus, Danmark
- Investigational Site 6010
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Arhus N., Danmark
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Copenhagen, Danmark
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Herlev, Danmark
- Investigational Site 6003
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Ringvej, Danmark
-
Svendborg, Danmark
- Investigational Site 6001
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-
-
-
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Barnaul, Den Russiske Føderation
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Chelyabinsk, Den Russiske Føderation
- Investigational Site 3023
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Irkutsk, Den Russiske Føderation
- Investigational Site 3017
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Kemerovo, Den Russiske Føderation
- Investigational Site 3019
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Krasnoyarsk, Den Russiske Føderation
- Investigational Site 3020
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Krasnoyarsk, Den Russiske Føderation
- Investigational Site 3030
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Moscow, Den Russiske Føderation
- Investigational Site 3029
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Novosibirsk, Den Russiske Føderation
- Investigational Site 3028
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Omsk, Den Russiske Føderation
- Investigational Site 3009
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Ryazan, Den Russiske Føderation
- Investigational Site 3022
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Saratov, Den Russiske Føderation
-
Sochi, Den Russiske Føderation
- Investigational Site 3024
-
St. Petersburg, Den Russiske Føderation
- Investigational Site 3000
-
St. Petersburg, Den Russiske Føderation
- Investigational Site 3003
-
St. Petersburg, Den Russiske Føderation
- Investigational Site 3027
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Tyumen, Den Russiske Føderation
- Investigational Site 3025
-
Ufa, Den Russiske Føderation
- Investigational Site 3016
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Yaroslavl, Den Russiske Føderation
- Investigational Site 3004
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Yaroslavl, Den Russiske Føderation
- Investigational Site 3010
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-
-
-
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Coventry, Det Forenede Kongerige
- Investigational Site 7005
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Hull, Det Forenede Kongerige
- Investigational Site 7006
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London, Det Forenede Kongerige
- Investigational Site 7000
-
London, Det Forenede Kongerige
- Investigational Site 7003
-
London, Det Forenede Kongerige
- Investigational Site 7004
-
Newcastle, Det Forenede Kongerige
- Investigational Site 7001
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Plymouth, Det Forenede Kongerige
- Investigational Site 7007
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-
-
-
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Tallinn, Estland
- Investigational Site 2100
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Tallinn, Estland
- Investigational Site 2101
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Tartu, Estland
- Investigational Site 2102
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-
-
-
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Pasig City, Filippinerne
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Quezon City, Filippinerne
- Investigational Site 4800
-
Quezon City, Filippinerne
- Investigational site 4801
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Quezon City, Filippinerne
- Investigational Site 4802
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-
-
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Alabama
-
Mobile, Alabama, Forenede Stater, 36608
- Investigational Site 7103
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Montgomery, Alabama, Forenede Stater, 36116
- Investigational Site 7132
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85006
- Investigational Site 7126
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Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- Investigational Site 7139
-
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California
-
Anaheim, California, Forenede Stater, 92801
- Investigational Site 1070
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Los Alamitos, California, Forenede Stater, 90720
- Investigational Site 7125
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Monterey, California, Forenede Stater, 93940
- Investigational Site 1093
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Palm Springs, California, Forenede Stater, 92262
- Investigational Site 1069
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San Diego, California, Forenede Stater, 92123
- Investigational Site 7150
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Vista, California, Forenede Stater, 92083
- Investigational Site 1089
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Investigational Site 1012
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Boulder, Colorado, Forenede Stater, 80303
- Investigational Site 1013
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Denver, Colorado, Forenede Stater, 80218
- Investigational Site 1017
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Lakewood, Colorado, Forenede Stater, 80228
- Investigational Site 1018
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Littleton, Colorado, Forenede Stater, 80120-4413
- Investigational Site 1019
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Thornton, Colorado, Forenede Stater, 80260
- Investigational Site 1022
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Thornton, Colorado, Forenede Stater, 80260
- Investigational Site 1023
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Florida
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Brandon, Florida, Forenede Stater
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Clearwater, Florida, Forenede Stater, 33756
- Investigational Site 1071
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Fort Myers, Florida, Forenede Stater, 33907
- Investigational Site 7117
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Gainesville, Florida, Forenede Stater, 32605
- Investigational Site 7106
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Ocoee, Florida, Forenede Stater, 34761
- Investigational Site 1005
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Orlando, Florida, Forenede Stater, 32806
- Investigational Site 1006
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Saint Petersburg, Florida, Forenede Stater, 33707
- Investigational Site 7127
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Sarasota, Florida, Forenede Stater, 34232
- Investigational Site 7144
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Winter Park, Florida, Forenede Stater, 32789
- Investigational Site 1007
-
-
Georgia
-
Albany, Georgia, Forenede Stater, 31701
- Investigational Site 7104
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Columbus, Georgia, Forenede Stater, 31904
- Investigational Site 1095
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Jonesboro, Georgia, Forenede Stater, 30236
- Investigational Site 1080
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Savannah, Georgia, Forenede Stater, 31419
- Investigational Site 7146
-
-
Illinois
-
Park Ridge, Illinois, Forenede Stater, 60068
- Investigational Site 1098
-
-
Indiana
-
Carmel, Indiana, Forenede Stater
-
-
Kentucky
-
Paducah, Kentucky, Forenede Stater, 42003
- Investigational Site 7115
-
-
Louisiana
-
Covington, Louisiana, Forenede Stater, 70433
- Investigational Site 1065
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21215
- Investigational Site 1068
-
Westminster, Maryland, Forenede Stater, 21157
- Investigational Site 1037
-
Westminster, Maryland, Forenede Stater, 21157
- Investigational Site 1038
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64128
- Investigational Site 7133
-
-
Montana
-
Butte, Montana, Forenede Stater, 59701
- Investigational Site 7147
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89169
- Investigational Site 1039
-
-
New York
-
Rochester, New York, Forenede Stater, 14642
- Investigational Site 7143
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Investigational Site 7135
-
Statesville, North Carolina, Forenede Stater, 28625
- Investigational Site 7145
-
-
Ohio
-
Maumee, Ohio, Forenede Stater, 43537
- Investigational Site 7138
-
Toledo, Ohio, Forenede Stater, 43606
- Investigational Site 7122
-
-
Oregon
-
Bend, Oregon, Forenede Stater, 97701
- Investigational Site 7152
-
Portland, Oregon, Forenede Stater
-
-
Pennsylvania
-
Camp Hill, Pennsylvania, Forenede Stater, 17011
- Investigational Site 1004
-
Ephrata, Pennsylvania, Forenede Stater, 17522
- Investigational Site 7109
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Kingston, Pennsylvania, Forenede Stater, 18704
- Investigational Site 1049
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Lancaster, Pennsylvania, Forenede Stater, 17602
- Investigational Site 7109
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Sellersville, Pennsylvania, Forenede Stater
- Investigational Site 7154
-
Uniontown, Pennsylvania, Forenede Stater
- Investigational Site 7128
-
-
South Carolina
-
Easley, South Carolina, Forenede Stater, 29640
- Investigational Site 1031
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Greenville, South Carolina, Forenede Stater, 29605
- Investigational Site 1032
-
Greenville, South Carolina, Forenede Stater, 29605
- Investigational Site 1034
-
Greenville, South Carolina, Forenede Stater, 29615
- Investigational Site 1033
-
Seneca, South Carolina, Forenede Stater, 29672
- Investigational Site 1035
-
Spartanburg, South Carolina, Forenede Stater, 29307
- Investigational Site 1036
-
-
Texas
-
Arlington, Texas, Forenede Stater, 76014-2084
- Investigational Site 1009
-
Dallas, Texas, Forenede Stater
- Investigational Site 1050
-
Fort Worth, Texas, Forenede Stater, 76104
- Investigational Site 1047
-
Fort Worth, Texas, Forenede Stater, 76109
- Investigational Site 7105
-
Fort Worth, Texas, Forenede Stater, 76132
- Investigational Site 1048
-
Midland, Texas, Forenede Stater
- Investigational Site 1059
-
New Braunfels, Texas, Forenede Stater, 78130
- Investigational Site 1040
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Odessa, Texas, Forenede Stater
- Investigational Site 1041
-
San Antonio, Texas, Forenede Stater, 78229
- Investigational Site 1002
-
Sugar Land, Texas, Forenede Stater
- Investigational Site 1058
-
Tyler, Texas, Forenede Stater
- Investigational Site 1042
-
Waco, Texas, Forenede Stater
- Investigational Site 1008
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater
- Investigational Site 7123
-
-
Virginia
-
Fredericksburg, Virginia, Forenede Stater
- Investigational Site 1003
-
Newport News, Virginia, Forenede Stater
- Investigational Site 1025
-
Norfolk, Virginia, Forenede Stater
- Investigational Site 1024
-
Randallstown, Virginia, Forenede Stater
- Investigational Site 1066
-
Virginia Beach, Virginia, Forenede Stater
- Investigational Site 1030
-
-
Washington
-
Seattle, Washington, Forenede Stater
- Investigational Site 7120
-
Tacoma, Washington, Forenede Stater
- Investigational Site 1076
-
Vancouver, Washington, Forenede Stater
- Investigational Site 1053
-
Vancouver, Washington, Forenede Stater
- Investigational Site 1056
-
Vancouver, Washington, Forenede Stater
- Investigational Site 1057
-
-
-
-
-
Agen, Frankrig
- Investigational Site 3314
-
Amiens, Frankrig
- Investigational Site 3302
-
Angers, Frankrig
- Investigational Site 3311
-
Annecy, Frankrig
- Investigational Site 3321
-
Arras, Frankrig
- Investigational Site 3300
-
Besancon Cedex, Frankrig
- Investigational Site 3301
-
Bordeaux, Frankrig
- Investigational Site 3329
-
Brest, Frankrig
- Investigational Site 3310
-
Cannes, Frankrig
- Investigational Site 3333
-
Colombes Cedex, Frankrig
- Investigational Site 3327
-
Dijon, Frankrig
- Investigational Site 3323
-
Grenoble, Frankrig
- Investigational Site 3307
-
Grenoble, Frankrig
- Investigational Site 3322
-
Hetztessy, Frankrig
- Investigational Site 3325
-
Le Mans, Frankrig
- Investigational Site 3328
-
Lille, Frankrig
- Investigational Site 3339
-
Lormont, Frankrig
-
Lyon, Frankrig
- Investigational Site 3318
-
Montpellier, Frankrig
- Investigational Site 3303
-
Nantes, Frankrig
-
Nice, Frankrig
- Investigational Site 3319
-
Paris, Frankrig
- Investigational Site 3308
-
Paris, Frankrig
- Investigational Site 3312
-
Paris, Frankrig
- Investigational Site 3313
-
Paris, Frankrig
- Investigational Site 3337
-
Pessac, Frankrig
- Investigational Site 3335
-
Pessac, Frankrig
- Investigational Site 3341
-
Pierre Benite, Frankrig
- Investigational Site 3336
-
Roskilde, Frankrig
-
Saint Aubin Surscie, Frankrig
-
Saint-Etienne Cedex, Frankrig
- Investigational Site 3305
-
Toulon, Frankrig
- Investigational Site 3316
-
-
-
-
-
Alkmaar, Holland
- Investigational Site 3608
-
Almere, Holland
- Investigational Site 3607
-
Amersfoort, Holland
- Investigational Site 3617
-
Amsterdam, Holland
- Investigational Site 3611
-
Assen, Holland
- Investigational Site 3609
-
Groningen, Holland
- Investigational Site 3603
-
Heerlen, Holland
- Investigational Site 3612
-
Hoofddorp, Holland
- Investigational Site 3613
-
Nijmegen, Holland
- Investigational Site 3602
-
Rotterdam, Holland
- Investigational Site 3615
-
-
-
-
-
Gomel, Hviderusland
- Investigational Site 2703
-
Grodno, Hviderusland
- Investigational Site 2704
-
Minsk, Hviderusland
- Investigational Site 2700
-
Minsk, Hviderusland
- Investigational Site 2701
-
Minsk, Hviderusland
- Investigational Site 2702
-
Mogilev, Hviderusland
- Investigational Site 2705
-
-
-
-
-
Ahmedabad, Indien
-
Andhra Pradesh, Indien
-
Bangalore, Indien
- Investigational Site 4402
-
Bangalore, Indien
- Investigational Site 4405
-
Bangalore, Indien
- Investigational Site 4442
-
Bangalore, Indien
- Investigational Site 4459
-
Bangalore, Indien
- Investigational Site 4460
-
Bangalore, Indien
- Investigational Site 4472
-
Gujarat, Indien
-
Gurgaon, Indien
-
Haryana, Indien
-
Holon, Indien
- Investigational Site 5514
-
Hyderabad, Indien
- Investigational Site 4407
-
Hyderabad, Indien
- Investigational Site 4430
-
Hyderabad, Indien
- Investigational Site 4444
-
Hyderabad, Indien
- Investigational Site 4451
-
Karnataka, Indien
-
Kerala, Indien
-
Lucknow, Indien
- Investigational Site 4420
-
Madhya Pradesh, Indien
-
Maharashtra, Indien
-
Mumbai, Indien
- Investigational Site 4409
-
Mumbai, Indien
- Investigational Site 4424
-
New Delhi, Indien
- Investigational Site 4419
-
New Delhi, Indien
- Investigational Site 4428
-
New Delhi, Indien
- Investigational Site 4441
-
Pune, Indien
- Investigational Site 4425
-
Pune, Indien
- Investigational Site 4438
-
Pune, Indien
- Investigational Site 4443
-
Pune, Indien
- Investigational Site 4462
-
Punjab, Indien
-
Rajasthan, Indien
-
Secunderbad, Indien
- Investigational Site 4470
-
Tamil Nadu, Indien
-
Uttar Pradesh, Indien
-
Vadodara, Indien
-
Visakhapatnam, Indien
-
-
-
-
-
Afula, Israel
-
Ashkelon, Israel
-
Hadera, Israel
-
Haifa, Israel
- Investigational Site 5506
-
Haifa, Israel
- Investigational Site 5508
-
Holon, Israel
- Investigational Site 5500
-
Jerusalem, Israel
- Investigational Site 5501
-
Kfar Saba, Israel
- Investigational Site 5505
-
Nahariya, Israel
- Investigational Site 5513
-
Petah-Tikva, Israel
- Investigational Site 5510
-
Poriya, Israel
- Investigational Site 5512
-
Tel Aviv, Israel
- Investigational Site 5503
-
Tel Hashomer, Israel
- Investigational Site 5509
-
-
-
-
-
Bergamo, Italien
- Investigational Site 3508
-
Chieti, Italien
- Investigational Site 3506
-
Emilia, Italien
- Investigational Site 3500
-
Milano, Italien
- Investigational Site 3504
-
Padova, Italien
-
Palermo, Italien
- Investigational Site 3502
-
Parma, Italien
- Investigational Site 3507
-
Pavia, Italien
- Investigational Site 3501
-
Rozzano, Italien
- Investigational Site 3505
-
Udine, Italien
- Investigational Site 3510
-
Varese, Italien
- Investigational Site 3503
-
Venezia, Italien
- Investigational Site 3509
-
-
-
-
-
Aichi, Japan
- Investigational Site 6137
-
Aomori, Japan
- Investigational Site 6104
-
Chiba, Japan
- Investigational Site 6117
-
Fukuoka, Japan
-
Fukuoka, Japan
- Investigational Site 6119
-
Fukushima, Japan
- Investigational Site 6110
-
Hiroshima, Japan
- Investigational Site 6150
-
Hokkaido, Japan
- Investigational Site 6138
-
Hokkaido, Japan
- Investigational Site 6141
-
Hyogo, Japan
-
Hyogo, Japan
- Investigational Site 6133
-
Ishikawa, Japan
- Investigational Site 6114
-
Kagoshima, Japan
- Investigational Site 6144
-
Kanagawa, Japan
- Investigational Site 6112
-
Kumamoto, Japan
- Investigational Site 6123
-
Kumamoto, Japan
- Investigational Site 6147
-
Kumamoto, Japan
- Investigational Site 6148
-
Mie, Japan
- Investigational Site 6129
-
Nagano, Japan
- Investigational Site 6146
-
Nagasaki, Japan
- Investigational Site 6139
-
Niigata, Japan
- Investigational Site 6107
-
Okayama, Japan
- Investigational Site 6152
-
Okinawa, Japan
- Investigational Site 6135
-
Osaka, Japan
- Investigational Site 6132
-
Sapporo, Japan
- Investigational Site 6130
-
Shizuoka, Japan
- Investigational Site 6143
-
Tokyo, Japan
- Investigational Site 6102
-
Tokyo, Japan
- Investigational Site 6105
-
Tokyo, Japan
- Investigational Site 6113
-
Tokyo, Japan
- Investigational Site 6142
-
Tokyo, Japan
- Investigational Site 6145
-
Tottori, Japan
- Investigational Site 6149
-
-
-
-
-
Ankara, Kalkun
- Investigational Site 5702
-
Ankara, Kalkun
- Investigational Site 5703
-
Istanbul, Kalkun
- Investigational Site 5702
-
Istanbul, Kalkun
- Investigational Site 5706
-
-
-
-
-
Beijing, Kina
- Investigational Site 4301
-
Beijing, Kina
- Investigational Site 4302
-
Beijing, Kina
- Investigational Site 4306
-
Beijing, Kina
- Investigational Site 4321
-
Beijing, Kina
- Investigational Site 4327
-
Beijing, Kina
- Investigational Site 4337
-
Guangzhou, Kina
- Investigational Site 4316
-
Hangzhou, Kina
- Investigational Site 4310
-
Hebei Province, Kina
-
Jiangsu, Kina
- Investigational Site 4325
-
Kunming, Kina
- Investigational Site 4317
-
Nanjing, Kina
- Investigational Site 4328
-
Nanning, Kina
- Investigational Site 4319
-
Qingdao, Kina
- Investigational Site 4313
-
Shanghai, Kina
- Investigational Site 4303
-
Shanghai, Kina
- Investigational Site 4324
-
Shanghai, Kina
- Investigational Site 4330
-
Shanghai, Kina
- Investigational Site 4335
-
Shenyang, Kina
- Investigational Site 4326
-
Sichuan Province, Kina
- Investigational Site 4308
-
Taiyuan, Kina
- Investigational Site 4318
-
Tianjin, Kina
- Investigational Site 4320
-
Xi'an, Kina
- Investigational site 4338
-
Yinchuan, Kina
- Investigational Site 4315
-
-
-
-
-
Busan, Korea, Republikken
- Investigational Site 4513
-
Daegu, Korea, Republikken
- Investigational Site 4509
-
Gyeonggi-do, Korea, Republikken
- Investigational Site 4501
-
Seoul, Korea, Republikken
- Investigational Site 4506
-
Seoul, Korea, Republikken
- Investigational Site 4507
-
Seoul, Korea, Republikken
- Investigational Site 4508
-
Seoul, Korea, Republikken
- Investigational Site 4515
-
-
-
-
-
Col. Lomas Altas C.P, Mexico
- Investigational Site 1311
-
Guadalajara, Mexico
- Investigational Site 1304
-
Guadalajara, Mexico
- Investigational Site 1312
-
Hermosillo, Mexico
- Investigational Site 1300
-
Monterrey, Nuevo Leon, Mexico
- Investigational Site 1305
-
San Luis Potosi, Mexico
- Investigational Site 1308
-
Yucatan, Mexico
- Investigational Site 1301
-
-
Jalisco
-
Zapopan, Jalisco, Mexico
- Investigational Site 1303
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico
- Investigational Site 1302
-
-
-
-
-
Auckland, New Zealand
- Investigational Site 4702
-
Auckland, New Zealand
- Investigational Site 4703
-
Christchurch, New Zealand
- Investigational Site 4700
-
Wellington, New Zealand
- Investigational Site 4704
-
-
-
-
-
Fredrikstad, Norge
- Investigational Site 3701
-
Oslo, Norge
- Investigational Site 3700
-
-
-
-
-
Bialystok, Polen
- Investigational Site 5015
-
Krakow, Polen
- Investigational Site 5005
-
Olsztyn, Polen
- Investigational Site 5019
-
Tarnow, Polen
- Investigational Site 5018
-
Warszawa, Polen
- Investigational Site 5003
-
Warszawa, Polen
- Investigational Site 5007
-
Warszawa, Polen
- Investigational Site 5008
-
Warszawa, Polen
- Investigational Site 5014
-
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Aarau, Schweiz
- Investigational Site 4103
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Basel, Schweiz
- Investigational Site 4110
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Bellinzona, Schweiz
- Investigational Site 4104
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Chur, Schweiz
- Investigational Site 4102
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Lausanne, Schweiz
- Investigational Site 4109
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Luzern, Schweiz
- Investigational Site 4100
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Outram Road, Singapore
- Investigational Site 5900
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Singapore, Singapore
- Investigational Site 5902
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Barcelona, Spanien
- Investigational site 1503
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Cabra, Spanien
- Investigational Site 1502
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Hallingsjo, Sverige
- Investigational Site 3900
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Kristianstad, Sverige
- Investigational Site 3904
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Stockholm, Sverige
- Investigational Site 3903
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Stockholm, Sverige
- Investigational Site 3905
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Sundsvall, Sverige
- Investigational Site 3902
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Cape Town, Sydafrika
- Investigational Site 4912
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Centurion, Sydafrika
- Investigational Site 4907
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Johannesburg, Sydafrika
- Investigational Site 4901
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Johannesburg, Sydafrika
- Investigational Site 4905
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Johannesburg, Sydafrika
- Investigational Site 4909
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Johannesburg, Sydafrika
- Investigational Site 4910
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Lyttleton, Sydafrika
- Investigational Site 4908
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Pretoria, Sydafrika
- Investigational Site 4903
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Pretoria, Sydafrika
- Investigational Site 4906
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Somerset West, Sydafrika
- Investigational Site 4904
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Worcester, Sydafrika
- Investigational Site 4900
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Hualien City, Taiwan
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Kaohsiung, Taiwan
- Investigational Site 5104
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Taichung, Taiwan
- Investigational Site 5105
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Taipei, Taiwan
- Investigational Site 5101
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Taipei, Taiwan
- Investigational Site 5103
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-
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Bangkok, Thailand
- Investigational Site 5200
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Bangkok, Thailand
- Investigational Site 5202
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Nakhorn Nayok, Thailand
- Investigational Site 5203
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Chodov, Tjekkiet
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Jihlava, Tjekkiet
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Liberec, Tjekkiet
- Investigational Site 1902
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Olomouc, Tjekkiet
- Investigational Site 1908
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Ostrava, Tjekkiet
- Investigational Site 1905
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Plzen, Tjekkiet
- Investigational Site 1901
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Plzen, Tjekkiet
- Investigational Site 1910
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Praha, Tjekkiet
- Investigational Site 1904
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Usti Nad Labem, Tjekkiet
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Berlin, Tyskland
- Investigational Site 1718
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Bielefeld, Tyskland
- Investigational Site 1720
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Bruchsal, Tyskland
- Investigational Site 1715
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Darmstadt, Tyskland
- Investigational Site 1700
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Dortmund, Tyskland
- Investigational Site 1719
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Dresden, Tyskland
- Investigational Site 1701
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Dresden, Tyskland
- Investigational Site 1707
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Hamburg, Tyskland
- Investigational Site 1721
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Magdeburg, Tyskland
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Mainz, Tyskland
- Investigational Site 1712
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Munchen, Tyskland
- Investigational Site 1704
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Nordhausen, Tyskland
- Investigational Site 1714
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Paderborn, Tyskland
- Investigational Site 1711
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Tubingen, Tyskland
- Investigational Site 1706
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Witten, Tyskland
- Investigational Site 1708
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Chernigiv, Ukraine
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Dnipropetrovsk, Ukraine
- Investigational Site 4008
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Donetsk, Ukraine
- Investigational Site 4010
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Ivano-Frankivsk, Ukraine
- Investigational Site 4000
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Kharkiv, Ukraine
- Investigational Site 4002
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Kiev, Ukraine
- Investigational Site 4001
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Ternopil, Ukraine
- Investigational Site 4007
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Uzhgorod, Ukraine
- Investigational Site 4009
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Vinnitsya, Ukraine
- Investigational Site 4003
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Zaporizhzhia, Ukraine
- Investigational Site 4006
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Baja, Ungarn
- Investigational Site 5413
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Budapest, Ungarn
- Investigational Site 5401
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Budapest, Ungarn
- Investigational Site 5404
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Budapest, Ungarn
- Investigational Site 5409
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Budapest, Ungarn
- Investigational Site 5414
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Debrecen, Ungarn
- Investigational Site 5400
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Kecskemet, Ungarn
- Investigational Site 5402
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Kistarcsa, Ungarn
- Investigational Site 5405
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Maglodi, Ungarn
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Miskolc, Ungarn
- Investigational Site 5407
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Pecs, Ungarn
- Investigational Site 5410
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Rakoczi, Ungarn
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Szentes, Ungarn
- Investigational Site 5403
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Szombathely, Ungarn
- Investigational Site 5408
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Zalaegerszeg, Ungarn
- Investigational Site 5412
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Zrinyi, Ungarn
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Feldkirch, Østrig
- Investigational Site 2802
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Graz, Østrig
- Investigational Site 2803
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Innsbruck, Østrig
- Investigational Site 2800
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Linz, Østrig
- Investigational Site 2804
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Sr. M. Restitutagasse, Østrig
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Vienna, Østrig
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Mandlige eller kvindelige forsøgspersoner, der er ældre end den lovlige minimumsalder (landespecifikt);
- Akut symptomatisk proksimal DVT og/eller symptomatisk PE bekræftet på stedet ved passende diagnostisk billeddannelse;
- Kan give skriftligt informeret samtykke
Ekskluderingskriterier:
- trombektomi, indsættelse af et kavalefilter eller brug af et fibrinolytisk middel til at behandle den aktuelle episode af DVT og/eller PE;
- Mere end 48 timer før behandling med antikoagulantbehandling før randomisering;
- Beregnet kreatininclearance (CrCL) < 30 ml/min;
- signifikant leversygdom (f.eks. akut hepatitis, kronisk aktiv hepatitis, cirrose) eller alanintransaminase (ALT) >\= 2 gange den øvre grænse for normal (ULN) eller total bilirubin (TBL) x 1,5 gange ULN;
- patienter med aktiv cancer, for hvem der forventes langtidsbehandling med (LMW) heparin;
- aktiv blødning eller høj risiko for blødning kontraindikerende behandling med (LMW) heparin eller warfarin;
- kronisk behandling med non-aspirin non-steroide antiinflammatoriske lægemidler (NSAID'er);
- behandling med aspirin i en dosis på mere end 100 mg/dag eller dobbelt antiblodpladebehandling;
- samtidig behandling med potente P-gp-hæmmere;
- forsøgspersoner med en hvilken som helst betingelse, som efter investigator vurderet, ville placere forsøgspersonen i øget risiko for skade, hvis han/hun deltog i undersøgelsen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: heparin/warfarin
|
LMW heparin - subkutan injektion, 1 mg/kg 2 gange dagligt eller 1,5 mg/kg 1 gang dagligt. Ufraktioneret heparin - 5.000 IE bolus intravenøs administration, 1.300 IE/time kontinuerlig infusion, minimum 5 dage og maksimum ca. 12 dages behandling
tablet til oral brug; 0,5 mg, 1 mg, 2,5 mg, 5 mg; daglig dosis, justeret for at opretholde international normaliseret ratio (INR) mellem 2,0 og 3,0; maksimalt 12 måneders behandling
|
Eksperimentel: heparin/edoxaban tosylat
|
edoxabantosylat(DU-176b), filmovertrukket tablet til oral brug, 30 mg, to tabletter (60 mg) én gang dagligt, maksimalt 12 måneders behandling
LMW heparin - subkutan injektion, 1 mg/kg 2 gange dagligt eller 1,5 mg/kg 1 gang dagligt. Ufraktioneret heparin - 5.000 IE bolus intravenøs administration, 1.300 IE/time kontinuerlig infusion, minimum 5 dage og maksimum ca. 12 dages behandling |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Symptomatisk tilbagevendende VTE, dvs. sammensætningen af DVT, ikke-dødelig PE og fatal PE
Tidsramme: 12 måneder fra randomiseringstidspunktet
|
Symptomatisk tilbagevendende venøs tromboembolisme (VTE), dvs. sammensætningen af dyb venetrombose (DVT), ikke-dødelig lungeemboli (PE) og fatal PE, der forekommer i løbet af den samlede undersøgelsesperiode. Samlet undersøgelsesperiode defineret som "Tidspunktet fra referencedatoen (randomiseringsdato/startdosis af studielægemiddeldato) til det sidste undersøgelsesopfølgningsbesøg." |
12 måneder fra randomiseringstidspunktet
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Det sammensatte kliniske resultat af symptomatisk tilbagevendende VTE og dødelighed af alle årsager
Tidsramme: 12 måneder fra randomiseringstidspunktet
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12 måneder fra randomiseringstidspunktet
|
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Klinisk relevant blødning (dvs. større eller klinisk relevant ikke-større blødning), der opstår under behandling
Tidsramme: 12 måneder fra randomiseringstidspunktet
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Klinisk relevant blødning (dvs. større eller klinisk relevant ikke-større blødning), der forekommer under behandlingen plus 3 dage efter deres sidste dosis for denne periode.
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12 måneder fra randomiseringstidspunktet
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13.
- Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8.
- Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1.
- Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1.
- Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27.
- Hokusai-VTE Investigators, Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum In: N Engl J Med. 2014 Jan 23;370(4):390.
- Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Luftvejssygdomme
- Lungesygdomme
- Embolisme og trombose
- Embolisme
- Trombose
- Venøs trombose
- Tromboemboli
- Venøs tromboembolisme
- Lungeemboli
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Proteasehæmmere
- Faktor Xa-hæmmere
- Antithrombiner
- Serinproteinasehæmmere
- Antikoagulanter
- Heparin
- Edoxaban
- Calcium heparin
- Heparin, lavmolekylær vægt
- Tinzaparin
- Dalteparin
- Warfarin
Andre undersøgelses-id-numre
- DU176b-D-U305
- The Edoxaban Hokusai VTE Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Klinisk undersøgelsesrapport (CSR)
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 edoxaban tosylat (DU-176b)
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Daiichi Sankyo Co., Ltd.AfsluttetIkke-valvulær atrieflimrenJapan
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Daiichi Sankyo Co., Ltd.Afsluttet
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Daiichi Sankyo Co., Ltd.AfsluttetDyb venetrombose | Venøs tromboembolisme | Total knæarthroplastikJapan
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Daiichi Sankyo, Inc.AfsluttetTrombose | Artroplastik, udskiftning, hofteForenede Stater
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Daiichi Sankyo Co., Ltd.AfsluttetVenøs tromboembolismeJapan
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Daiichi Sankyo Co., Ltd.AfsluttetSlag | AtrieflimrenTaiwan, Korea, Republikken, Singapore, Kina
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LifeBridge HealthDaiichi Sankyo, Inc.Ukendt
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National Cancer Institute (NCI)Trukket tilbageLokalt avanceret malignt fast neoplasma | Metastatisk malignt fast neoplasma | Aggressiv non-Hodgkin lymfom | Indolent non-Hodgkin lymfomForenede Stater
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Daiichi Sankyo, Inc.AfsluttetVenøs trombose | Dyb venetromboseForenede Stater, Canada
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Taivex Therapeutics CorporationAktiv, ikke rekrutterendeAvancerede ildfaste solide tumorerTaiwan