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).
2 other identifiers
interventional
8,292
35 countries
440
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Typical duration for phase_3
440 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
February 25, 2015
CompletedMarch 5, 2019
March 1, 2015
3.5 years
September 25, 2009
February 5, 2015
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
12 months from time of randomization
Study Arms (2)
heparin/edoxaban tosylate
EXPERIMENTALheparin/warfarin
ACTIVE COMPARATORInterventions
edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (454)
Investigational Site 7103
Mobile, Alabama, 36608, United States
Investigational Site 7132
Montgomery, Alabama, 36116, United States
Investigational Site 7126
Phoenix, Arizona, 85006, United States
Investigational Site 7139
Little Rock, Arkansas, 72205, United States
Investigational Site 1070
Anaheim, California, 92801, United States
Investigational Site 7125
Los Alamitos, California, 90720, United States
Investigational Site 1093
Monterey, California, 93940, United States
Investigational Site 1069
Palm Springs, California, 92262, United States
Investigational Site 7150
San Diego, California, 92123, United States
Investigational Site 1089
Vista, California, 92083, United States
Investigational Site 1012
Aurora, Colorado, 80012, United States
Investigational Site 1013
Boulder, Colorado, 80303, United States
Investigational Site 1017
Denver, Colorado, 80218, United States
Investigational Site 1018
Lakewood, Colorado, 80228, United States
Investigational Site 1019
Littleton, Colorado, 80120-4413, United States
Investigational Site 1022
Thornton, Colorado, 80260, United States
Investigational Site 1023
Thornton, Colorado, 80260, United States
Unknown Facility
Brandon, Florida, United States
Investigational Site 1071
Clearwater, Florida, 33756, United States
Investigational Site 7117
Fort Myers, Florida, 33907, United States
Investigational Site 7106
Gainesville, Florida, 32605, United States
Investigational Site 1005
Ocoee, Florida, 34761, United States
Investigational Site 1006
Orlando, Florida, 32806, United States
Investigational Site 7144
Sarasota, Florida, 34232, United States
Investigational Site 7127
St. Petersburg, Florida, 33707, United States
Investigational Site 1007
Winter Park, Florida, 32789, United States
Investigational Site 7104
Albany, Georgia, 31701, United States
Investigational Site 1095
Columbus, Georgia, 31904, United States
Investigational Site 1080
Jonesboro, Georgia, 30236, United States
Investigational Site 7146
Savannah, Georgia, 31419, United States
Investigational Site 1098
Park Ridge, Illinois, 60068, United States
Unknown Facility
Carmel, Indiana, United States
Investigational Site 7115
Paducah, Kentucky, 42003, United States
Investigational Site 1065
Covington, Louisiana, 70433, United States
Investigational Site 1068
Baltimore, Maryland, 21215, United States
Investigational Site 1037
Westminster, Maryland, 21157, United States
Investigational Site 1038
Westminster, Maryland, 21157, United States
Investigational Site 7133
Kansas City, Missouri, 64128, United States
Investigational Site 7147
Butte, Montana, 59701, United States
Investigational Site 1039
Las Vegas, Nevada, 89169, United States
Investigational Site 7143
Rochester, New York, 14642, United States
Investigational Site 7135
Durham, North Carolina, 27710, United States
Investigational Site 7145
Statesville, North Carolina, 28625, United States
Investigational Site 7138
Maumee, Ohio, 43537, United States
Investigational Site 7122
Toledo, Ohio, 43606, United States
Investigational Site 7152
Bend, Oregon, 97701, United States
Unknown Facility
Portland, Oregon, United States
Investigational Site 1004
Camp Hill, Pennsylvania, 17011, United States
Investigational Site 7109
Ephrata, Pennsylvania, 17522, United States
Investigational Site 1049
Kingston, Pennsylvania, 18704, United States
Investigational Site 7109
Lancaster, Pennsylvania, 17602, United States
Investigational Site 7154
Sellersville, Pennsylvania, United States
Investigational Site 7128
Uniontown, Pennsylvania, United States
Investigational Site 1031
Easley, South Carolina, 29640, United States
Investigational Site 1032
Greenville, South Carolina, 29605, United States
Investigational Site 1034
Greenville, South Carolina, 29605, United States
Investigational Site 1033
Greenville, South Carolina, 29615, United States
Investigational Site 1035
Seneca, South Carolina, 29672, United States
Investigational Site 1036
Spartanburg, South Carolina, 29307, United States
Investigational Site 1009
Arlington, Texas, 76014-2084, United States
Investigational Site 1050
Dallas, Texas, United States
Investigational Site 1047
Fort Worth, Texas, 76104, United States
Investigational Site 7105
Fort Worth, Texas, 76109, United States
Investigational Site 1048
Fort Worth, Texas, 76132, United States
Investigational Site 1059
Midland, Texas, United States
Investigational Site 1040
New Braunfels, Texas, 78130, United States
Investigational Site 1041
Odessa, Texas, United States
Investigational Site 1002
San Antonio, Texas, 78229, United States
Investigational Site 1058
Sugar Land, Texas, United States
Investigational Site 1042
Tyler, Texas, United States
Investigational Site 1008
Waco, Texas, United States
Investigational Site 7123
Salt Lake City, Utah, United States
Investigational Site 1003
Fredericksburg, Virginia, United States
Investigational Site 1025
Newport News, Virginia, United States
Investigational Site 1024
Norfolk, Virginia, United States
Investigational Site 1066
Randallstown, Virginia, United States
Investigational Site 1030
Virginia Beach, Virginia, United States
Investigational Site 7120
Seattle, Washington, United States
Investigational Site 1076
Tacoma, Washington, United States
Investigational Site 1053
Vancouver, Washington, United States
Investigational Site 1056
Vancouver, Washington, United States
Investigational Site 1057
Vancouver, Washington, United States
Investigational Site 1100
Buenos Aires, Argentina
Investigational Site 1103
Buenos Aires, Argentina
Investigational Site 1106
Buenos Aires, Argentina
Investigational Site 1108
Buenos Aires, Argentina
Investigational Site 1104
Córdoba, Argentina
Investigational Site 1110
Pcia de Corrientes, Argentina
Investigational Site 1109
Santa Fe, Argentina
Investigational Site 4205
Bedford Park, Australia
Investigational Site 4209
Box Hill, Australia
Investigational Site 4210
Clayton, Australia
Investigational Site 4211
Fremantle, Australia
Investigational Site 4213
Garran, Australia
Unknown Facility
Kogarah, Australia
Investigational Site 4207
Perth, Australia
Investigational Site 4203
Redcliffe, Australia
Investigational Site 4206
Saint Leonards NSW, Australia
Investigational Site 4214
South Brisbane, Australia
Investigational Site 4212
Westmead NSW, Australia
Investigational Site 4200
Windsor, Australia
Investigational Site 2802
Feldkirch, Austria
Investigational Site 2803
Graz, Austria
Investigational Site 2800
Innsbruck, Austria
Investigational Site 2804
Linz, Austria
Unknown Facility
Sr. M. Restitutagasse, Austria
Unknown Facility
Vienna, Austria
Investigational Site 2704
Grodno, Belarus
Investigational Site 2703
Homyel, Belarus
Investigational Site 2700
Minsk, Belarus
Investigational site 2701
Minsk, Belarus
Investigational Site 2702
Minsk, Belarus
Investigational Site 2705
Mogilev, Belarus
Investigational Site 1608
Aalst, Belgium
Investigational Site 1602
Lier, Belgium
Investigational Site 2905
Belo Horizonte, Brazil
Investigational Site 2914
Campinas, Brazil
Investigational Site 2901
Curitiba, Brazil
Investigational Site 2903
Curitiba, Brazil
Investigational Site 2912
Porto Alegre, Brazil
Investigational Site 2915
Porto Alegre, Brazil
Investigational Site 2917
Porto Alegre, Brazil
Investigational Site 2904
São Bernardo do Campo, Brazil
Investigational Site 2900
São Paulo, Brazil
Investigational Site 2902
São Paulo, Brazil
Investigational Site 2906
São Paulo, Brazil
Investigational Site 2910
São Paulo, Brazil
Investigational Site 2911
São Paulo, Brazil
Investigational Site 2006
Edmonton, Alberta, Canada
Investigational Site 2001
London, Ontario, Canada
Investigational Site 2007
Newmarket, Ontario, Canada
Investigational Site 2000
Ottawa, Ontario, Canada
Investigational Site 2003
Richmond Hill, Ontario, Canada
Investigational Site 2005
Halifax, Canada
Investigational Site 2004
Montreal, Canada
Investigational Site 1200
Santiago, Chile
Investigational Site 1204
Santiago, Chile
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
Beijing, China
Investigational Site 4316
Guangzhou, China
Investigational Site 4310
Hangzhou, China
Unknown Facility
Hebei Province, China
Investigational Site 4325
Jiangsu, China
Investigational Site 4317
Kunming, China
Investigational Site 4328
Nanjing, China
Investigational Site 4319
Nanning, China
Investigational Site 4313
Qingdao, China
Investigational Site 4303
Shanghai, China
Investigational Site 4324
Shanghai, China
Investigational Site 4330
Shanghai, China
Investigational Site 4335
Shanghai, China
Investigational Site 4326
Shenyang, China
Investigational Site 4308
Sichuan Province, China
Investigational Site 4318
Taiyuan, China
Investigational Site 4320
Tianjin, China
Investigational site 4338
Xi'an, China
Investigational Site 4315
Yinchuan, China
Unknown Facility
Chodov, Czechia
Unknown Facility
Jihlava, Czechia
Investigational Site 1902
Liberec, Czechia
Investigational Site 1908
Olomouc, Czechia
Investigational Site 1905
Ostrava, Czechia
Investigational Site 1901
Pilsen, Czechia
Investigational Site 1910
Pilsen, Czechia
Investigational Site 1904
Prague, Czechia
Unknown Facility
Ústí nad Labem, Czechia
Investigational Site 6010
Aarhus, Denmark
Unknown Facility
Arhus N., Denmark
Unknown Facility
Copenhagen, Denmark
Investigational Site 6003
Herlev, Denmark
Unknown Facility
Ringvej, Denmark
Investigational Site 6001
Svendborg, Denmark
Investigational Site 2100
Tallinn, Estonia
Investigational Site 2101
Tallinn, Estonia
Investigational Site 2102
Tartu, Estonia
Investigational Site 3314
Agen, France
Investigational Site 3302
Amiens, France
Investigational Site 3311
Angers, France
Investigational Site 3321
Annecy, France
Investigational Site 3300
Arras, France
Investigational Site 3301
Besançon, France
Investigational Site 3329
Bordeaux, France
Investigational Site 3310
Brest, France
Investigational Site 3333
Cannes, France
Investigational Site 3327
Colombes, France
Investigational Site 3323
Dijon, France
Investigational Site 3307
Grenoble, France
Investigational Site 3322
Grenoble, France
Investigational Site 3325
Hetztessy, France
Investigational Site 3328
Le Mans, France
Investigational Site 3339
Lille, France
Unknown Facility
Lormont, France
Investigational Site 3318
Lyon, France
Investigational Site 3303
Montpellier, France
Unknown Facility
Nantes, France
Investigational Site 3319
Nice, France
Investigational Site 3308
Paris, France
Investigational Site 3312
Paris, France
Investigational Site 3313
Paris, France
Investigational Site 3337
Paris, France
Investigational Site 3335
Pessac, France
Investigational Site 3341
Pessac, France
Investigational Site 3336
Pierre-Bénite, France
Unknown Facility
Roskilde, France
Unknown Facility
Saint Aubin Surscie, France
Investigational Site 3305
Saint-Etienne, France
Investigational Site 3316
Toulon, France
Investigational Site 1718
Berlin, Germany
Investigational Site 1720
Bielefeld, Germany
Investigational Site 1715
Bruchsal, Germany
Investigational Site 1700
Darmstadt, Germany
Investigational Site 1719
Dortmund, Germany
Investigational Site 1701
Dresden, Germany
Investigational Site 1707
Dresden, Germany
Investigational Site 1721
Hamburg, Germany
Unknown Facility
Magdeburg, Germany
Investigational Site 1712
Mainz, Germany
Investigational Site 1704
München, Germany
Investigational Site 1714
Nordhausen, Germany
Investigational Site 1711
Paderborn, Germany
Investigational Site 1706
Tübingen, Germany
Investigational Site 1708
Witten, Germany
Investigational Site 5413
Baja, Hungary
Investigational Site 5401
Budapest, Hungary
Investigational Site 5404
Budapest, Hungary
Investigational Site 5409
Budapest, Hungary
Investigational Site 5414
Budapest, Hungary
Investigational Site 5400
Debrecen, Hungary
Investigational Site 5402
Kecskemét, Hungary
Investigational Site 5405
Kistarcsa, Hungary
Unknown Facility
Maglodi, Hungary
Investigational Site 5407
Miskolc, Hungary
Investigational Site 5410
Pécs, Hungary
Unknown Facility
Rakoczi, Hungary
Investigational Site 5403
Szentes, Hungary
Investigational Site 5408
Szombathely, Hungary
Investigational Site 5412
Zalaegerszeg, Hungary
Unknown Facility
Zrinyi, Hungary
Unknown Facility
Ahmedabad, India
Unknown Facility
Andhra Pradesh, 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
Bangalore, India
Unknown Facility
Gujarat, India
Unknown Facility
Gūrgaon, India
Unknown Facility
Haryāna, India
Investigational Site 5514
Holon, India
Investigational Site 4407
Hyderabad, India
Investigational Site 4430
Hyderabad, India
Investigational Site 4444
Hyderabad, India
Investigational Site 4451
Hyderabad, India
Unknown Facility
Karnataka, India
Unknown Facility
Kerala, India
Investigational Site 4420
Lucknow, India
Unknown Facility
Madhya Pradesh, India
Unknown Facility
Maharashtra, India
Investigational Site 4409
Mumbai, India
Investigational Site 4424
Mumbai, India
Investigational Site 4419
New Delhi, India
Investigational Site 4428
New Delhi, India
Investigational Site 4441
New Delhi, India
Investigational Site 4425
Pune, India
Investigational Site 4438
Pune, India
Investigational Site 4443
Pune, India
Investigational Site 4462
Pune, India
Unknown Facility
Punjab, India
Unknown Facility
Rajasthan, India
Investigational Site 4470
Secunderbad, India
Unknown Facility
Tamil Nadu, India
Unknown Facility
Uttar Pradesh, India
Unknown Facility
Vadodara, India
Unknown Facility
Visakhapatnam, India
Unknown Facility
Afula, Israel
Unknown Facility
Ashkelon, Israel
Unknown Facility
Hadera, Israel
Investigational Site 5506
Haifa, Israel
Investigational Site 5508
Haifa, Israel
Investigational Site 5500
Holon, Israel
Investigational Site 5501
Jerusalem, Israel
Investigational Site 5505
Kfar Saba, Israel
Investigational Site 5513
Nahariya, Israel
Investigational Site 5510
Petah Tikva, Israel
Investigational Site 5512
Poria – Neve Oved, Israel
Investigational Site 5503
Tel Aviv, Israel
Investigational Site 5509
Tel Litwinsky, Israel
Investigational Site 3508
Bergamo, Italy
Investigational Site 3506
Chieti, Italy
Investigational Site 3500
Emilia, Italy
Investigational Site 3504
Milan, Italy
Unknown Facility
Padua, Italy
Investigational Site 3502
Palermo, Italy
Investigational Site 3507
Parma, Italy
Investigational Site 3501
Pavia, Italy
Investigational Site 3505
Rozzano, Italy
Investigational Site 3510
Udine, Italy
Investigational Site 3503
Varese, Italy
Investigational Site 3509
Venezia, Italy
Investigational Site 6137
Aichi, Japan
Investigational Site 6104
Aomori, Japan
Investigational Site 6117
Chiba, Japan
Investigational Site 6119
Fukuoka, Japan
Unknown Facility
Fukuoka, Japan
Investigational Site 6110
Fukushima, Japan
Investigational Site 6150
Hiroshima, Japan
Investigational Site 6138
Hokkaido, Japan
Investigational Site 6141
Hokkaido, Japan
Investigational Site 6133
Hyōgo, Japan
Unknown Facility
Hyōgo, Japan
Investigational Site 6114
Ishikawa, Japan
Investigational Site 6144
Kagoshima, Japan
Investigational Site 6112
Kanagawa, Japan
Investigational Site 6123
Kumamoto, Japan
Investigational Site 6147
Kumamoto, Japan
Investigational Site 6148
Kumamoto, Japan
Investigational Site 6129
Mie, Japan
Investigational Site 6146
Nagano, Japan
Investigational Site 6139
Nagasaki, Japan
Investigational Site 6107
Niigata, Japan
Investigational Site 6152
Okayama, Japan
Investigational Site 6135
Okinawa, Japan
Investigational Site 6132
Osaka, Japan
Investigational Site 6130
Sapporo, Japan
Investigational Site 6143
Shizuoka, Japan
Investigational Site 6102
Tokyo, Japan
Investigational Site 6105
Tokyo, Japan
Investigational Site 6113
Tokyo, Japan
Investigational Site 6142
Tokyo, Japan
Investigational Site 6145
Tokyo, Japan
Investigational Site 6149
Tottori, Japan
Investigational Site 1303
Zapopan, Jalisco, Mexico
Investigational Site 1302
Monterrey, Nuevo León, Mexico
Investigational Site 1311
Col. Lomas Altas C.P, Mexico
Investigational Site 1304
Guadalajara, Mexico
Investigational Site 1312
Guadalajara, Mexico
Investigational Site 1300
Hermosillo, Mexico
Investigational Site 1305
Monterrey, Nuevo Leon, Mexico
Investigational Site 1308
San Luis Potosí City, Mexico
Investigational Site 1301
Yucatán, Mexico
Investigational Site 3608
Alkmaar, Netherlands
Investigational Site 3607
Almere Stad, Netherlands
Investigational Site 3617
Amersfoort, Netherlands
Investigational Site 3611
Amsterdam, Netherlands
Investigational Site 3609
Assen, Netherlands
Investigational Site 3603
Groningen, Netherlands
Investigational Site 3612
Heerlen, Netherlands
Investigational Site 3613
Hoofddorp, Netherlands
Investigational Site 3602
Nijmegen, Netherlands
Investigational Site 3615
Rotterdam, Netherlands
Investigational Site 4702
Auckland, New Zealand
Investigational Site 4703
Auckland, New Zealand
Investigational Site 4700
Christchurch, New Zealand
Investigational Site 4704
Wellington, New Zealand
Investigational Site 3701
Fredrikstad, Norway
Investigational Site 3700
Oslo, Norway
Unknown Facility
Pasig, Philippines
Investigational Site 4800
Quezon City, Philippines
Investigational site 4801
Quezon City, Philippines
Investigational Site 4802
Quezon City, Philippines
Investigational Site 5015
Bialystok, Poland
Investigational Site 5005
Krakow, Poland
Investigational Site 5019
Olsztyn, Poland
Investigational Site 5018
Tarnów, Poland
Investigational Site 5003
Warsaw, Poland
Investigational Site 5007
Warsaw, Poland
Investigational Site 5008
Warsaw, Poland
Investigational Site 5014
Warsaw, Poland
Unknown Facility
Barnaul, Russia
Investigational Site 3023
Chelyabinsk, Russia
Investigational Site 3017
Irkutsk, Russia
Investigational Site 3019
Kemerovo, Russia
Investigational Site 3020
Krasnoyarsk, Russia
Investigational Site 3030
Krasnoyarsk, Russia
Investigational Site 3029
Moscow, Russia
Investigational Site 3028
Novosibirsk, Russia
Investigational Site 3009
Omsk, Russia
Investigational Site 3022
Ryazan, Russia
Investigational Site 3000
Saint Petersburg, Russia
Investigational Site 3003
Saint Petersburg, Russia
Investigational Site 3027
Saint Petersburg, Russia
Unknown Facility
Saratov, Russia
Investigational Site 3024
Sochi, Russia
Investigational Site 3025
Tyumen, Russia
Investigational Site 3016
Ufa, Russia
Investigational Site 3004
Yaroslavl, Russia
Investigational Site 3010
Yaroslavl, Russia
Investigational Site 5900
Outram Road, Singapore
Investigational Site 5902
Singapore, Singapore
Investigational Site 4912
Cape Town, South Africa
Investigational Site 4907
Centurion, South Africa
Investigational Site 4901
Johannesburg, South Africa
Investigational Site 4905
Johannesburg, South Africa
Investigational Site 4909
Johannesburg, South Africa
Investigational Site 4910
Johannesburg, South Africa
Investigational Site 4908
Lyttleton, South Africa
Investigational Site 4903
Pretoria, South Africa
Investigational Site 4906
Pretoria, South Africa
Investigational Site 4904
Somerset West, South Africa
Investigational Site 4900
Worcester, South Africa
Investigational Site 4513
Busan, South Korea
Investigational Site 4509
Daegu, South Korea
Investigational Site 4501
Gyeonggi-do, South Korea
Investigational Site 4506
Seoul, South Korea
Investigational Site 4507
Seoul, South Korea
Investigational Site 4508
Seoul, South Korea
Investigational Site 4515
Seoul, South Korea
Investigational site 1503
Barcelona, Spain
Investigational Site 1502
Cabra, Spain
Investigational Site 3900
Hällingsjö, Sweden
Investigational Site 3904
Kristianstad, Sweden
Investigational Site 3903
Stockholm, Sweden
Investigational Site 3905
Stockholm, Sweden
Investigational Site 3902
Sundsvall, Sweden
Investigational Site 4103
Aarau, Switzerland
Investigational Site 4110
Basel, Switzerland
Investigational Site 4104
Bellinzona, Switzerland
Investigational Site 4102
Chur, Switzerland
Investigational Site 4109
Lausanne, Switzerland
Investigational Site 4100
Lucerne, Switzerland
Unknown Facility
Hualien City, Taiwan
Investigational Site 5104
Kaohsiung City, Taiwan
Investigational Site 5105
Taichung, Taiwan
Investigational Site 5101
Taipei, Taiwan
Investigational Site 5103
Taipei, Taiwan
Investigational Site 5200
Bangkok, Thailand
Investigational Site 5202
Bangkok, Thailand
Investigational Site 5203
Nakhorn Nayok, Thailand
Investigational Site 5702
Ankara, Turkey (Türkiye)
Investigational Site 5703
Ankara, Turkey (Türkiye)
Investigational Site 5702
Istanbul, Turkey (Türkiye)
Investigational Site 5706
Istanbul, Turkey (Türkiye)
Unknown Facility
Chernihiv, Ukraine
Investigational Site 4008
Dnipropetrovsk, Ukraine
Investigational Site 4010
Donetsk, Ukraine
Investigational Site 4000
Ivano-Frankivsk, Ukraine
Investigational Site 4002
Kharkiv, Ukraine
Investigational Site 4001
Kiev, Ukraine
Investigational Site 4007
Ternopil, Ukraine
Investigational Site 4009
Uzhhorod, Ukraine
Investigational Site 4003
Vinnitsya, Ukraine
Investigational Site 4006
Zaporizhzhia, Ukraine
Investigational Site 7005
Coventry, United Kingdom
Investigational Site 7006
Hull, United Kingdom
Investigational Site 7000
London, United Kingdom
Investigational Site 7003
London, United Kingdom
Investigational Site 7004
London, United Kingdom
Investigational Site 7001
Newcastle, United Kingdom
Investigational Site 7007
Plymouth, United Kingdom
Related Publications (8)
Christodoulou KC, Barco S, Abele C, Lodigiani C, Monreal M, Konstantinides SV, Valerio L. Burden of Atherosclerosis and Outcomes of Acute Pulmonary Embolism: A Post Hoc Analysis of the Hokusai-VTE Trial. J Am Heart Assoc. 2025 Nov 18;14(22):e041420. doi: 10.1161/JAHA.125.041420. Epub 2025 Nov 6.
PMID: 41195787DERIVEDVanassche 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.
PMID: 29248859DERIVEDVandell 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.
PMID: 28689179DERIVEDBrekelmans 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.
PMID: 27570090DERIVEDRaskob 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.
PMID: 27476789DERIVEDNakamura 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.
PMID: 26179767DERIVEDHokusai-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.
PMID: 23991658DERIVEDCamm 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.
PMID: 21861537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lee Schwocho, Sr. Director
- Organization
- Daiichi Sankyo, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 29, 2009
Study Start
October 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 5, 2019
Results First Posted
February 25, 2015
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/