Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)
• Intervention / Treatment: Drug: edoxaban tosylate(DU-176b); Drug: low molecular weight heparin/unfractionated heparin; Drug: warfarin

• Study Type: Interventional
• Enrollment (Actual): 8292
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Investigational Site 1100
  • Buenos Aires, Argentina
    • Investigational Site 1103
  • Buenos Aires, Argentina
    • Investigational Site 1106
  • Buenos Aires, Argentina
    • Investigational Site 1108
  • Cordoba, Argentina
    • Investigational Site 1104
  • Pcia De Corrientes, Argentina
    • Investigational Site 1110
  • Santa Fe, Argentina
    • Investigational Site 1109
• Australia
  • Bedford Park, Australia
    • Investigational Site 4205
  • Box Hill, Australia
    • Investigational Site 4209
  • Clayton, Australia
    • Investigational Site 4210
  • Fremantle, Australia
    • Investigational Site 4211
  • Garran, Australia
    • Investigational Site 4213
  • Kogarah, Australia
  • Perth, Australia
    • Investigational Site 4207
  • Redcliffe, Australia
    • Investigational Site 4203
  • Saint Leonards NSW, Australia
    • Investigational Site 4206
  • South Brisbane, Australia
    • Investigational Site 4214
  • Westmead NSW, Australia
    • Investigational Site 4212
  • Windsor, Australia
    • Investigational Site 4200
• Austria
  • Feldkirch, Austria
    • Investigational Site 2802
  • Graz, Austria
    • Investigational Site 2803
  • Innsbruck, Austria
    • Investigational Site 2800
  • Linz, Austria
    • Investigational Site 2804
  • Sr. M. Restitutagasse, Austria
  • Vienna, Austria
• Belarus
  • Gomel, Belarus
    • Investigational Site 2703
  • Grodno, Belarus
    • Investigational Site 2704
  • Minsk, Belarus
    • Investigational Site 2700
  • Minsk, Belarus
    • Investigational Site 2701
  • Minsk, Belarus
    • Investigational Site 2702
  • Mogilev, Belarus
    • Investigational Site 2705
• Belgium
  • Aalst, Belgium
    • Investigational Site 1608
  • Lier, Belgium
    • Investigational Site 1602
• Brazil
  • Belo Horizonte, Brazil
    • Investigational Site 2905
  • Campinas, Brazil
    • Investigational Site 2914
  • Curitiba, Brazil
    • Investigational Site 2901
  • Curitiba, Brazil
    • Investigational Site 2903
  • Porto Alegre, Brazil
    • Investigational Site 2912
  • Porto Alegre, Brazil
    • Investigational Site 2915
  • Porto Alegre, Brazil
    • Investigational Site 2917
  • Sao Bernardo do Campo, Brazil
    • Investigational Site 2904
  • Sao Paulo, Brazil
    • Investigational Site 2900
  • Sao Paulo, Brazil
    • Investigational Site 2902
  • Sao Paulo, Brazil
    • Investigational Site 2906
  • Sao Paulo, Brazil
    • Investigational Site 2910
  • Sao Paulo, Brazil
    • Investigational Site 2911
• Canada
  • Halifax, Canada
    • Investigational Site 2005
  • Montreal, Canada
    • Investigational Site 2004
  • Alberta
    • Edmonton, Alberta, Canada
      • Investigational Site 2006
  • Ontario
    • London, Ontario, Canada
      • Investigational Site 2001
    • Newmarket, Ontario, Canada
      • Investigational Site 2007
    • Ottawa, Ontario, Canada
      • Investigational Site 2000
    • Richmond Hill, Ontario, Canada
      • Investigational Site 2003
• Chile
  • Santiago, Chile
    • Investigational Site 1200
  • Santiago, Chile
    • Investigational Site 1204
• China
  • Beijing, China
    • Investigational Site 4301
  • Beijing, China
    • Investigational Site 4302
  • Beijing, China
    • Investigational Site 4306
  • Beijing, China
    • Investigational Site 4321
  • Beijing, China
    • Investigational Site 4327
  • Beijing, China
    • Investigational Site 4337
  • Guangzhou, China
    • Investigational Site 4316
  • Hangzhou, China
    • Investigational Site 4310
  • Hebei Province, China
  • Jiangsu, China
    • Investigational Site 4325
  • Kunming, China
    • Investigational Site 4317
  • Nanjing, China
    • Investigational Site 4328
  • Nanning, China
    • Investigational Site 4319
  • Qingdao, China
    • Investigational Site 4313
  • Shanghai, China
    • Investigational Site 4303
  • Shanghai, China
    • Investigational Site 4324
  • Shanghai, China
    • Investigational Site 4330
  • Shanghai, China
    • Investigational Site 4335
  • Shenyang, China
    • Investigational Site 4326
  • Sichuan Province, China
    • Investigational Site 4308
  • Taiyuan, China
    • Investigational Site 4318
  • Tianjin, China
    • Investigational Site 4320
  • Xi'an, China
    • Investigational site 4338
  • Yinchuan, China
    • Investigational Site 4315
• Czechia
  • Chodov, Czechia
  • Jihlava, Czechia
  • Liberec, Czechia
    • Investigational Site 1902
  • Olomouc, Czechia
    • Investigational Site 1908
  • Ostrava, Czechia
    • Investigational Site 1905
  • Plzen, Czechia
    • Investigational Site 1901
  • Plzen, Czechia
    • Investigational Site 1910
  • Praha, Czechia
    • Investigational Site 1904
  • Usti Nad Labem, Czechia
• Denmark
  • Aarhus, Denmark
    • Investigational Site 6010
  • Arhus N., Denmark
  • Copenhagen, Denmark
  • Herlev, Denmark
    • Investigational Site 6003
  • Ringvej, Denmark
  • Svendborg, Denmark
    • Investigational Site 6001
• Estonia
  • Tallinn, Estonia
    • Investigational Site 2100
  • Tallinn, Estonia
    • Investigational Site 2101
  • Tartu, Estonia
    • Investigational Site 2102
• France
  • Agen, France
    • Investigational Site 3314
  • Amiens, France
    • Investigational Site 3302
  • Angers, France
    • Investigational Site 3311
  • Annecy, France
    • Investigational Site 3321
  • Arras, France
    • Investigational Site 3300
  • Besancon Cedex, France
    • Investigational Site 3301
  • Bordeaux, France
    • Investigational Site 3329
  • Brest, France
    • Investigational Site 3310
  • Cannes, France
    • Investigational Site 3333
  • Colombes Cedex, France
    • Investigational Site 3327
  • Dijon, France
    • Investigational Site 3323
  • Grenoble, France
    • Investigational Site 3307
  • Grenoble, France
    • Investigational Site 3322
  • Hetztessy, France
    • Investigational Site 3325
  • Le Mans, France
    • Investigational Site 3328
  • Lille, France
    • Investigational Site 3339
  • Lormont, France
  • Lyon, France
    • Investigational Site 3318
  • Montpellier, France
    • Investigational Site 3303
  • Nantes, France
  • Nice, France
    • Investigational Site 3319
  • Paris, France
    • Investigational Site 3308
  • Paris, France
    • Investigational Site 3312
  • Paris, France
    • Investigational Site 3313
  • Paris, France
    • Investigational Site 3337
  • Pessac, France
    • Investigational Site 3335
  • Pessac, France
    • Investigational Site 3341
  • Pierre Benite, France
    • Investigational Site 3336
  • Roskilde, France
  • Saint Aubin Surscie, France
  • Saint-Etienne Cedex, France
    • Investigational Site 3305
  • Toulon, France
    • Investigational Site 3316
• Germany
  • Berlin, Germany
    • Investigational Site 1718
  • Bielefeld, Germany
    • Investigational Site 1720
  • Bruchsal, Germany
    • Investigational Site 1715
  • Darmstadt, Germany
    • Investigational Site 1700
  • Dortmund, Germany
    • Investigational Site 1719
  • Dresden, Germany
    • Investigational Site 1701
  • Dresden, Germany
    • Investigational Site 1707
  • Hamburg, Germany
    • Investigational Site 1721
  • Magdeburg, Germany
  • Mainz, Germany
    • Investigational Site 1712
  • Munchen, Germany
    • Investigational Site 1704
  • Nordhausen, Germany
    • Investigational Site 1714
  • Paderborn, Germany
    • Investigational Site 1711
  • Tubingen, Germany
    • Investigational Site 1706
  • Witten, Germany
    • Investigational Site 1708
• Hungary
  • Baja, Hungary
    • Investigational Site 5413
  • Budapest, Hungary
    • Investigational Site 5401
  • Budapest, Hungary
    • Investigational Site 5404
  • Budapest, Hungary
    • Investigational Site 5409
  • Budapest, Hungary
    • Investigational Site 5414
  • Debrecen, Hungary
    • Investigational Site 5400
  • Kecskemet, Hungary
    • Investigational Site 5402
  • Kistarcsa, Hungary
    • Investigational Site 5405
  • Maglodi, Hungary
  • Miskolc, Hungary
    • Investigational Site 5407
  • Pecs, Hungary
    • Investigational Site 5410
  • Rakoczi, Hungary
  • Szentes, Hungary
    • Investigational Site 5403
  • Szombathely, Hungary
    • Investigational Site 5408
  • Zalaegerszeg, Hungary
    • Investigational Site 5412
  • Zrinyi, Hungary
• India
  • Ahmedabad, India
  • Andhra Pradesh, India
  • Bangalore, India
    • Investigational Site 4402
  • Bangalore, India
    • Investigational Site 4405
  • Bangalore, India
    • Investigational Site 4442
  • Bangalore, India
    • Investigational Site 4459
  • Bangalore, India
    • Investigational Site 4460
  • Bangalore, India
    • Investigational Site 4472
  • Gujarat, India
  • Gurgaon, India
  • Haryana, India
  • Holon, India
    • Investigational Site 5514
  • Hyderabad, India
    • Investigational Site 4407
  • Hyderabad, India
    • Investigational Site 4430
  • Hyderabad, India
    • Investigational Site 4444
  • Hyderabad, India
    • Investigational Site 4451
  • Karnataka, India
  • Kerala, India
  • Lucknow, India
    • Investigational Site 4420
  • Madhya Pradesh, India
  • Maharashtra, India
  • Mumbai, India
    • Investigational Site 4409
  • Mumbai, India
    • Investigational Site 4424
  • New Delhi, India
    • Investigational Site 4419
  • New Delhi, India
    • Investigational Site 4428
  • New Delhi, India
    • Investigational Site 4441
  • Pune, India
    • Investigational Site 4425
  • Pune, India
    • Investigational Site 4438
  • Pune, India
    • Investigational Site 4443
  • Pune, India
    • Investigational Site 4462
  • Punjab, India
  • Rajasthan, India
  • Secunderbad, India
    • Investigational Site 4470
  • Tamil Nadu, India
  • Uttar Pradesh, India
  • Vadodara, India
  • Visakhapatnam, India
• Israel
  • 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
• Italy
  • Bergamo, Italy
    • Investigational Site 3508
  • Chieti, Italy
    • Investigational Site 3506
  • Emilia, Italy
    • Investigational Site 3500
  • Milano, Italy
    • Investigational Site 3504
  • Padova, Italy
  • Palermo, Italy
    • Investigational Site 3502
  • Parma, Italy
    • Investigational Site 3507
  • Pavia, Italy
    • Investigational Site 3501
  • Rozzano, Italy
    • Investigational Site 3505
  • Udine, Italy
    • Investigational Site 3510
  • Varese, Italy
    • Investigational Site 3503
  • Venezia, Italy
    • Investigational Site 3509
• Japan
  • 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
• Korea, Republic of
  • Busan, Korea, Republic of
    • Investigational Site 4513
  • Daegu, Korea, Republic of
    • Investigational Site 4509
  • Gyeonggi-do, Korea, Republic of
    • Investigational Site 4501
  • Seoul, Korea, Republic of
    • Investigational Site 4506
  • Seoul, Korea, Republic of
    • Investigational Site 4507
  • Seoul, Korea, Republic of
    • Investigational Site 4508
  • Seoul, Korea, Republic of
    • Investigational Site 4515
• Mexico
  • 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
• Netherlands
  • Alkmaar, Netherlands
    • Investigational Site 3608
  • Almere, Netherlands
    • Investigational Site 3607
  • Amersfoort, Netherlands
    • Investigational Site 3617
  • Amsterdam, Netherlands
    • Investigational Site 3611
  • Assen, Netherlands
    • Investigational Site 3609
  • Groningen, Netherlands
    • Investigational Site 3603
  • Heerlen, Netherlands
    • Investigational Site 3612
  • Hoofddorp, Netherlands
    • Investigational Site 3613
  • Nijmegen, Netherlands
    • Investigational Site 3602
  • Rotterdam, Netherlands
    • Investigational Site 3615
• New Zealand
  • Auckland, New Zealand
    • Investigational Site 4702
  • Auckland, New Zealand
    • Investigational Site 4703
  • Christchurch, New Zealand
    • Investigational Site 4700
  • Wellington, New Zealand
    • Investigational Site 4704
• Norway
  • Fredrikstad, Norway
    • Investigational Site 3701
  • Oslo, Norway
    • Investigational Site 3700
• Philippines
  • Pasig City, Philippines
  • Quezon City, Philippines
    • Investigational Site 4800
  • Quezon City, Philippines
    • Investigational site 4801
  • Quezon City, Philippines
    • Investigational Site 4802
• Poland
  • Bialystok, Poland
    • Investigational Site 5015
  • Krakow, Poland
    • Investigational Site 5005
  • Olsztyn, Poland
    • Investigational Site 5019
  • Tarnow, Poland
    • Investigational Site 5018
  • Warszawa, Poland
    • Investigational Site 5003
  • Warszawa, Poland
    • Investigational Site 5007
  • Warszawa, Poland
    • Investigational Site 5008
  • Warszawa, Poland
    • Investigational Site 5014
• Russian Federation
  • Barnaul, Russian Federation
  • Chelyabinsk, Russian Federation
    • Investigational Site 3023
  • Irkutsk, Russian Federation
    • Investigational Site 3017
  • Kemerovo, Russian Federation
    • Investigational Site 3019
  • Krasnoyarsk, Russian Federation
    • Investigational Site 3020
  • Krasnoyarsk, Russian Federation
    • Investigational Site 3030
  • Moscow, Russian Federation
    • Investigational Site 3029
  • Novosibirsk, Russian Federation
    • Investigational Site 3028
  • Omsk, Russian Federation
    • Investigational Site 3009
  • Ryazan, Russian Federation
    • Investigational Site 3022
  • Saratov, Russian Federation
  • Sochi, Russian Federation
    • Investigational Site 3024
  • St. Petersburg, Russian Federation
    • Investigational Site 3000
  • St. Petersburg, Russian Federation
    • Investigational Site 3003
  • St. Petersburg, Russian Federation
    • Investigational Site 3027
  • Tyumen, Russian Federation
    • Investigational Site 3025
  • Ufa, Russian Federation
    • Investigational Site 3016
  • Yaroslavl, Russian Federation
    • Investigational Site 3004
  • Yaroslavl, Russian Federation
    • Investigational Site 3010
• Singapore
  • Outram Road, Singapore
    • Investigational Site 5900
  • Singapore, Singapore
    • Investigational Site 5902
• South Africa
  • Cape Town, South Africa
    • Investigational Site 4912
  • Centurion, South Africa
    • Investigational Site 4907
  • Johannesburg, South Africa
    • Investigational Site 4901
  • Johannesburg, South Africa
    • Investigational Site 4905
  • Johannesburg, South Africa
    • Investigational Site 4909
  • Johannesburg, South Africa
    • Investigational Site 4910
  • Lyttleton, South Africa
    • Investigational Site 4908
  • Pretoria, South Africa
    • Investigational Site 4903
  • Pretoria, South Africa
    • Investigational Site 4906
  • Somerset West, South Africa
    • Investigational Site 4904
  • Worcester, South Africa
    • Investigational Site 4900
• Spain
  • Barcelona, Spain
    • Investigational site 1503
  • Cabra, Spain
    • Investigational Site 1502
• Sweden
  • Hallingsjo, Sweden
    • Investigational Site 3900
  • Kristianstad, Sweden
    • Investigational Site 3904
  • Stockholm, Sweden
    • Investigational Site 3903
  • Stockholm, Sweden
    • Investigational Site 3905
  • Sundsvall, Sweden
    • Investigational Site 3902
• Switzerland
  • Aarau, Switzerland
    • Investigational Site 4103
  • Basel, Switzerland
    • Investigational Site 4110
  • Bellinzona, Switzerland
    • Investigational Site 4104
  • Chur, Switzerland
    • Investigational Site 4102
  • Lausanne, Switzerland
    • Investigational Site 4109
  • Luzern, Switzerland
    • Investigational Site 4100
• Taiwan
  • Hualien City, Taiwan
  • Kaohsiung, Taiwan
    • Investigational Site 5104
  • Taichung, Taiwan
    • Investigational Site 5105
  • Taipei, Taiwan
    • Investigational Site 5101
  • Taipei, Taiwan
    • Investigational Site 5103
• Thailand
  • Bangkok, Thailand
    • Investigational Site 5200
  • Bangkok, Thailand
    • Investigational Site 5202
  • Nakhorn Nayok, Thailand
    • Investigational Site 5203
• Turkey
  • Ankara, Turkey
    • Investigational Site 5702
  • Ankara, Turkey
    • Investigational Site 5703
  • Istanbul, Turkey
    • Investigational Site 5702
  • Istanbul, Turkey
    • Investigational Site 5706
• Ukraine
  • Chernigiv, Ukraine
  • Dnipropetrovsk, Ukraine
    • Investigational Site 4008
  • Donetsk, Ukraine
    • Investigational Site 4010
  • Ivano-Frankivsk, Ukraine
    • Investigational Site 4000
  • Kharkiv, Ukraine
    • Investigational Site 4002
  • Kiev, Ukraine
    • Investigational Site 4001
  • Ternopil, Ukraine
    • Investigational Site 4007
  • Uzhgorod, Ukraine
    • Investigational Site 4009
  • Vinnitsya, Ukraine
    • Investigational Site 4003
  • Zaporizhzhia, Ukraine
    • Investigational Site 4006
• United Kingdom
  • Coventry, United Kingdom
    • Investigational Site 7005
  • Hull, United Kingdom
    • Investigational Site 7006
  • London, United Kingdom
    • Investigational Site 7000
  • London, United Kingdom
    • Investigational Site 7003
  • London, United Kingdom
    • Investigational Site 7004
  • Newcastle, United Kingdom
    • Investigational Site 7001
  • Plymouth, United Kingdom
    • Investigational Site 7007
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Investigational Site 7103
    • Montgomery, Alabama, United States, 36116
      • Investigational Site 7132
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Investigational Site 7126
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Investigational Site 7139
  • California
    • Anaheim, California, United States, 92801
      • Investigational Site 1070
    • Los Alamitos, California, United States, 90720
      • Investigational Site 7125
    • Monterey, California, United States, 93940
      • Investigational Site 1093
    • Palm Springs, California, United States, 92262
      • Investigational Site 1069
    • San Diego, California, United States, 92123
      • Investigational Site 7150
    • Vista, California, United States, 92083
      • Investigational Site 1089
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Investigational Site 1012
    • Boulder, Colorado, United States, 80303
      • Investigational Site 1013
    • Denver, Colorado, United States, 80218
      • Investigational Site 1017
    • Lakewood, Colorado, United States, 80228
      • Investigational Site 1018
    • Littleton, Colorado, United States, 80120-4413
      • Investigational Site 1019
    • Thornton, Colorado, United States, 80260
      • Investigational Site 1022
    • Thornton, Colorado, United States, 80260
      • Investigational Site 1023
  • Florida
    • Brandon, Florida, United States
    • Clearwater, Florida, United States, 33756
      • Investigational Site 1071
    • Fort Myers, Florida, United States, 33907
      • Investigational Site 7117
    • Gainesville, Florida, United States, 32605
      • Investigational Site 7106
    • Ocoee, Florida, United States, 34761
      • Investigational Site 1005
    • Orlando, Florida, United States, 32806
      • Investigational Site 1006
    • Saint Petersburg, Florida, United States, 33707
      • Investigational Site 7127
    • Sarasota, Florida, United States, 34232
      • Investigational Site 7144
    • Winter Park, Florida, United States, 32789
      • Investigational Site 1007
  • Georgia
    • Albany, Georgia, United States, 31701
      • Investigational Site 7104
    • Columbus, Georgia, United States, 31904
      • Investigational Site 1095
    • Jonesboro, Georgia, United States, 30236
      • Investigational Site 1080
    • Savannah, Georgia, United States, 31419
      • Investigational Site 7146
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Investigational Site 1098
  • Indiana
    • Carmel, Indiana, United States
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Investigational Site 7115
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Investigational Site 1065
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Investigational Site 1068
    • Westminster, Maryland, United States, 21157
      • Investigational Site 1037
    • Westminster, Maryland, United States, 21157
      • Investigational Site 1038
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Investigational Site 7133
  • Montana
    • Butte, Montana, United States, 59701
      • Investigational Site 7147
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Investigational Site 1039
  • New York
    • Rochester, New York, United States, 14642
      • Investigational Site 7143
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Investigational Site 7135
    • Statesville, North Carolina, United States, 28625
      • Investigational Site 7145
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Investigational Site 7138
    • Toledo, Ohio, United States, 43606
      • Investigational Site 7122
  • Oregon
    • Bend, Oregon, United States, 97701
      • Investigational Site 7152
    • Portland, Oregon, United States
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Investigational Site 1004
    • Ephrata, Pennsylvania, United States, 17522
      • Investigational Site 7109
    • Kingston, Pennsylvania, United States, 18704
      • Investigational Site 1049
    • Lancaster, Pennsylvania, United States, 17602
      • Investigational Site 7109
    • Sellersville, Pennsylvania, United States
      • Investigational Site 7154
    • Uniontown, Pennsylvania, United States
      • Investigational Site 7128
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Investigational Site 1031
    • Greenville, South Carolina, United States, 29605
      • Investigational Site 1032
    • Greenville, South Carolina, United States, 29605
      • Investigational Site 1034
    • Greenville, South Carolina, United States, 29615
      • Investigational Site 1033
    • Seneca, South Carolina, United States, 29672
      • Investigational Site 1035
    • Spartanburg, South Carolina, United States, 29307
      • Investigational Site 1036
  • Texas
    • Arlington, Texas, United States, 76014-2084
      • Investigational Site 1009
    • Dallas, Texas, United States
      • Investigational Site 1050
    • Fort Worth, Texas, United States, 76104
      • Investigational Site 1047
    • Fort Worth, Texas, United States, 76109
      • Investigational Site 7105
    • Fort Worth, Texas, United States, 76132
      • Investigational Site 1048
    • Midland, Texas, United States
      • Investigational Site 1059
    • New Braunfels, Texas, United States, 78130
      • Investigational Site 1040
    • Odessa, Texas, United States
      • Investigational Site 1041
    • San Antonio, Texas, United States, 78229
      • Investigational Site 1002
    • Sugar Land, Texas, United States
      • Investigational Site 1058
    • Tyler, Texas, United States
      • Investigational Site 1042
    • Waco, Texas, United States
      • Investigational Site 1008
  • Utah
    • Salt Lake City, Utah, United States
      • Investigational Site 7123
  • Virginia
    • Fredericksburg, Virginia, United States
      • Investigational Site 1003
    • Newport News, Virginia, United States
      • Investigational Site 1025
    • Norfolk, Virginia, United States
      • Investigational Site 1024
    • Randallstown, Virginia, United States
      • Investigational Site 1066
    • Virginia Beach, Virginia, United States
      • Investigational Site 1030
  • Washington
    • Seattle, Washington, United States
      • Investigational Site 7120
    • Tacoma, Washington, United States
      • Investigational Site 1076
    • Vancouver, Washington, United States
      • Investigational Site 1053
    • Vancouver, Washington, United States
      • Investigational Site 1056
    • Vancouver, Washington, United States
      • Investigational Site 1057

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects older than the minimum legal adult age (country specific);
• Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
• Able to provide written informed consent

Exclusion Criteria:

• thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
• More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
• Calculated Creatinine clearance (CrCL) < 30 mL/min;
• significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
• patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
• active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
• chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
• treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
• concurrent treatment with potent P-gp inhibitors;
• subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: heparin/warfarin	Drug: low molecular weight heparin/unfractionated heparin; LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment; Drug: warfarin; tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
Experimental: heparin/edoxaban tosylate	Drug: edoxaban tosylate(DU-176b); edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment; Drug: low molecular weight heparin/unfractionated heparin; LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE	Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."	12 months from time of randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality		12 months from time of randomization
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment	Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.	12 months from time of randomization

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: September 25, 2009
• First Submitted That Met QC Criteria: September 28, 2009
• First Posted (Estimate): September 29, 2009

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Recurrent Thrombosis; Recurrent Pulmonary Embolism; Symptomatic Deep Vein Thrombosis; Symptomatic Pulmonary Embolism; Venous Thromboembolism (VTE)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Edoxaban; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Warfarin
• Other Study ID Numbers: DU176b-D-U305; The Edoxaban Hokusai VTE Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)