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).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00986154
First received: September 25, 2009
Last updated: June 20, 2014
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Thromboembolism
Venous Thrombosis
Drug: edoxaban tosylate(DU-176b)
Drug: low molecular weight heparin/unfractionated heparin
Drug: warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Symptomatic recurrent VTE, i.e., the composite of DVT, non-fatal PE, and fatal PE [ Time Frame: 12 months from time of randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE, and all-cause mortality [ Time Frame: 12 months from time of randomization ] [ Designated as safety issue: No ]
  • Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment [ Time Frame: 12 months from time of randomization ] [ Designated as safety issue: Yes ]

Enrollment: 8292
Study Start Date: October 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986154

  Hide Study Locations
Locations
United States, Alabama
Investigational Site 7103
Mobile, Alabama, United States, 36608
Investigational Site 7132
Montgomery, Alabama, United States, 36116
United States, Arizona
Investigational Site 7126
Phoenix, Arizona, United States, 85006
United States, Arkansas
Investigational Site 7139
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site 1070
Anaheim, California, United States, 92801
Investigational Site 7125
Los Alamitos, California, United States, 90720
Investigational Site 1093
Monterey, California, United States, 93940
Investigational Site 1069
Palm Springs, California, United States, 92262
Investigational Site 7150
San Diego, California, United States, 92123
Investigational Site 1089
Vista, California, United States, 92083
United States, Colorado
Investigational Site 1012
Aurora, Colorado, United States, 80012
Investigational Site 1013
Boulder, Colorado, United States, 80303
Investigational Site 1017
Denver, Colorado, United States, 80218
Investigational Site 1018
Lakewood, Colorado, United States, 80228
Investigational Site 1019
Littleton, Colorado, United States, 80120-4413
Investigational Site 1023
Thornton, Colorado, United States, 80260
Investigational Site 1022
Thornton, Colorado, United States, 80260
United States, Florida
Brandon, Florida, United States
Investigational Site 1071
Clearwater, Florida, United States, 33756
Investigational Site 7117
Fort Myers, Florida, United States, 33907
Investigational Site 7106
Gainesville, Florida, United States, 32605
Investigational Site 1005
Ocoee, Florida, United States, 34761
Investigational Site 1006
Orlando, Florida, United States, 32806
Investigational Site 7144
Sarasota, Florida, United States, 34232
Investigational Site 7127
St. Petersburg, Florida, United States, 33707
Investigational Site 1007
Winter Park, Florida, United States, 32789
United States, Georgia
Investigational Site 7104
Albany, Georgia, United States, 31701
Investigational Site 1095
Columbus, Georgia, United States, 31904
Investigational Site 1080
Jonesboro, Georgia, United States, 30236
Investigational Site 7146
Savannah, Georgia, United States, 31419
United States, Illinois
Investigational Site 1098
Park Ridge, Illinois, United States, 60068
United States, Indiana
Carmel, Indiana, United States
United States, Kentucky
Investigational Site 7115
Paducah, Kentucky, United States, 42003
United States, Louisiana
Investigational Site 1065
Covington, Louisiana, United States, 70433
United States, Maryland
Investigational Site 1068
Baltimore, Maryland, United States, 21215
Investigational Site 1038
Westminster, Maryland, United States, 21157
Investigational Site 1037
Westminster, Maryland, United States, 21157
United States, Missouri
Investigational Site 7133
Kansas City, Missouri, United States, 64128
United States, Montana
Investigational Site 7147
Butte, Montana, United States, 59701
United States, Nevada
Investigational Site 1039
Las Vegas, Nevada, United States, 89169
United States, New York
Investigational Site 7143
Rochester, New York, United States, 14642
United States, North Carolina
Investigational Site 7135
Durham, North Carolina, United States, 27710
Investigational Site 7145
Statesville, North Carolina, United States, 28625
United States, Ohio
Investigational Site 7138
Maumee, Ohio, United States, 43537
Investigational Site 7122
Toledo, Ohio, United States, 43606
United States, Oregon
Investigational Site 7152
Bend, Oregon, United States, 97701
Portland, Oregon, United States
United States, Pennsylvania
Investigational Site 1004
Camp Hill, Pennsylvania, United States, 17011
Investigational Site 7109
Ephrata, Pennsylvania, United States, 17522
Investigational Site 1049
Kingston, Pennsylvania, United States, 18704
Investigational Site 7109
Lancaster, Pennsylvania, United States, 17602
Investigational Site 7154
Sellersville, Pennsylvania, United States
Investigational Site 7128
Uniontown, Pennsylvania, United States
United States, South Carolina
Investigational Site 1031
Easley, South Carolina, United States, 29640
Investigational Site 1032
Greenville, South Carolina, United States, 29605
Investigational Site 1033
Greenville, South Carolina, United States, 29615
Investigational Site 1034
Greenville, South Carolina, United States, 29605
Investigational Site 1035
Seneca, South Carolina, United States, 29672
Investigational Site 1036
Spartanburg, South Carolina, United States, 29307
United States, Texas
Investigational Site 1009
Arlington, Texas, United States, 76014-2084
Investigational Site 1050
Dallas, Texas, United States
Investigational Site 7105
Fort Worth, Texas, United States, 76109
Investigational Site 1047
Fort Worth, Texas, United States, 76104
Investigational Site 1048
Fort Worth, Texas, United States, 76132
Investigational Site 1059
Midland, Texas, United States
Investigational Site 1040
New Braunfels, Texas, United States, 78130
Investigational Site 1041
Odessa, Texas, United States
Investigational Site 1002
San Antonio, Texas, United States, 78229
Investigational Site 1058
Sugar Land, Texas, United States
Investigational Site 1042
Tyler, Texas, United States
Investigational Site 1008
Waco, Texas, United States
United States, Utah
Investigational Site 7123
Salt Lake City, Utah, United States
United States, Virginia
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
United States, Washington
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
Argentina
Investigational Site 1103
Buenos Aires, Argentina
Investigational Site 1100
Buenos Aires, Argentina
Investigational Site 1108
Buenos Aires, Argentina
Investigational Site 1106
Buenos Aires, Argentina
Investigational Site 1104
Cordoba, Argentina
Investigational Site 1110
Pcia De Corrientes, Argentina
Investigational Site 1109
Santa Fe, Argentina
Australia
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
Kogarah, Australia
Investigational Site 4207
Perth, Australia
Investigational Site 4203
Redcliffe, Australia
Investigational Site 4214
South Brisbane, Australia
Investigational Site 4206
St. Leonards NSW, Australia
Investigational Site 4212
Westmead NSW, Australia
Investigational Site 4200
Windsor, Australia
Austria
Investigational Site 2802
Feldkirch, Austria
Investigational Site 2803
Graz, Austria
Investigational Site 2800
Innsbruck, Austria
Investigational Site 2804
Linz, Austria
Sr. M. Restitutagasse, Austria
Vienna, Austria
Belarus
Investigational Site 2703
Gomel, Belarus
Investigational Site 2704
Grodno, Belarus
Investigational site 2701
Minsk, Belarus
Investigational Site 2702
Minsk, Belarus
Investigational Site 2700
Minsk, Belarus
Investigational Site 2705
Mogilev, Belarus
Belgium
Investigational Site 1608
Aalst, Belgium
Investigational Site 1602
Lier, Belgium
Brazil
Investigational Site 2905
Belo Horizonte, Brazil
Investigational Site 2914
Campinas, Brazil
Investigational Site 2903
Curitiba, Brazil
Investigational Site 2901
Curitiba, Brazil
Investigational Site 2917
Porto Alegre, Brazil
Investigational Site 2912
Porto Alegre, Brazil
Investigational Site 2915
Porto Alegre, Brazil
Investigational Site 2904
Sao Bernardo do Campo, Brazil
Investigational Site 2906
Sao Paulo, Brazil
Investigational Site 2902
Sao Paulo, Brazil
Investigational Site 2910
Sao Paulo, Brazil
Investigational Site 2911
Sao Paulo, Brazil
Investigational Site 2900
Sao Paulo, Brazil
Canada, Alberta
Investigational Site 2006
Edmonton, Alberta, Canada
Canada, Ontario
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
Canada
Investigational Site 2005
Halifax, Canada
Investigational Site 2004
Montreal, Canada
Chile
Investigational Site 1204
Santiago, Chile
Investigational Site 1200
Santiago, Chile
China
Investigational Site 4302
Beijing, China
Investigational Site 4301
Beijing, China
Investigational Site 4321
Beijing, China
Investigational Site 4306
Beijing, China
Investigational Site 4337
Beijing, China
Investigational Site 4327
Beijing, China
Investigational Site 4316
Guangzhou, China
Investigational Site 4310
Hangzhou, China
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 4335
Shanghai, China
Investigational Site 4324
Shanghai, China
Investigational Site 4303
Shanghai, China
Investigational Site 4330
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
Czech Republic
Chodov, Czech Republic
Jihlava, Czech Republic
Investigational Site 1902
Liberec, Czech Republic
Investigational Site 1908
Olomouc, Czech Republic
Investigational Site 1905
Ostrava, Czech Republic
Investigational Site 1901
Plzen, Czech Republic
Investigational Site 1910
Plzen, Czech Republic
Investigational Site 1904
Praha, Czech Republic
Denmark
Investigational Site 6010
Aarhus, Denmark
Arhus N., Denmark
Copenhagen, Denmark
Investigational Site 6003
Herlev, Denmark
Ringvej, Denmark
Investigational Site 6001
Svendborg, Denmark
Estonia
Investigational Site 2101
Tallinn, Estonia
Investigational Site 2100
Tallinn, Estonia
Investigational Site 2102
Tartu, Estonia
France
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
Besancon Cedex, France
Investigational Site 3329
Bordeaux, France
Investigational Site 3310
Brest, France
Investigational Site 3333
Cannes, France
Investigational Site 3327
Colombes Cedex, France
Investigational Site 3323
Dijon, France
Investigational Site 3322
Grenoble, France
Investigational Site 3307
Grenoble, France
Investigational Site 3325
Hetztessy, France
Investigational Site 3328
Le Mans, France
Investigational Site 3339
Lille, France
Lormont, France
Investigational Site 3318
Lyon, France
Investigational Site 3303
Montpellier, France
Nantes, France
Investigational Site 3319
Nice, France
Investigational Site 3312
Paris, France
Investigational Site 3313
Paris, France
Investigational Site 3308
Paris, France
Investigational Site 3337
Paris, France
Investigational Site 3335
Pessac, France
Investigational Site 3341
Pessac, France
Investigational Site 3336
Pierre Benite, France
Roskilde, France
Saint Aubin Surscie, France
Investigational Site 3305
Saint-Etienne Cedex, France
Investigational Site 3316
Toulon, France
Germany
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
Magdeburg, Germany
Investigational Site 1712
Mainz, Germany
Investigational Site 1704
Munchen, Germany
Investigational Site 1714
Nordhausen, Germany
Investigational Site 1711
Paderborn, Germany
Investigational Site 1706
Tubingen, Germany
Investigational Site 1708
Witten, Germany
Hungary
Investigational Site 5413
Baja, Hungary
Investigational Site 5401
Budapest, Hungary
Investigational Site 5414
Budapest, Hungary
Investigational Site 5404
Budapest, Hungary
Investigational Site 5409
Budapest, Hungary
Investigational Site 5400
Debrecen, Hungary
Investigational Site 5402
Kecskemet, Hungary
Investigational Site 5405
Kistarcsa, Hungary
Maglodi, Hungary
Investigational Site 5407
Miskolc, Hungary
Investigational Site 5410
Pecs, Hungary
Rakoczi, Hungary
Investigational Site 5403
Szentes, Hungary
Investigational Site 5408
Szombathely, Hungary
Investigational Site 5412
Zalaegerszeg, Hungary
India
Andhra Pradesh, India
Investigational Site 4460
Bangalore, India
Investigational Site 4402
Bangalore, India
Investigational Site 4442
Bangalore, India
Investigational Site 4459
Bangalore, India
Investigational Site 4405
Bangalore, India
Investigational Site 4472
Bangalore, India
Gujarat, India
Haryana, India
Investigational Site 5514
Holon, India
Investigational Site 4430
Hyderabad, India
Investigational Site 4444
Hyderabad, India
Investigational Site 4451
Hyderabad, India
Investigational Site 4407
Hyderabad, India
Karnataka, India
Kerala, India
Investigational Site 4420
Lucknow, India
Madhya Pradesh, India
Maharashtra, India
Investigational Site 4409
Mumbai, India
Investigational Site 4424
Mumbai, India
Investigational Site 4428
New Delhi, India
Investigational Site 4419
New Delhi, India
Investigational Site 4441
New Delhi, India
Investigational Site 4443
Pune, India
Investigational Site 4438
Pune, India
Investigational Site 4425
Pune, India
Investigational Site 4462
Pune, India
Punjab, India
Rajasthan, India
Investigational Site 4470
Secunderbad, India
Tamil Nadu, India
Uttar Pradesh, India
Israel
Afula, Israel
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
Poriya, Israel
Investigational Site 5503
Tel Aviv, Israel
Investigational Site 5509
Tel Hashomer, Israel
Italy
Investigational Site 3508
Bergamo, Italy
Investigational Site 3506
Chieti, Italy
Investigational Site 3500
Emilia, Italy
Investigational Site 3504
Milano, Italy
Padova, 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
Japan
Investigational Site 6137
Aichi, Japan
Investigational Site 6104
Aomori, Japan
Investigational Site 6117
Chiba, Japan
Investigational Site 6119
Fukuoka, Japan
Fukuoka, Japan
Investigational Site 6110
Fukushima, Japan
Investigational Site 6150
Hiroshima, Japan
Investigational Site 6141
Hokkaido, Japan
Investigational Site 6138
Hokkaido, Japan
Hyogo, Japan
Investigational Site 6133
Hyogo, Japan
Investigational Site 6114
Ishikawa, Japan
Investigational Site 6144
Kagoshima, Japan
Investigational Site 6112
Kanagawa, Japan
Investigational Site 6148
Kumamoto, Japan
Investigational Site 6123
Kumamoto, Japan
Investigational Site 6147
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 6142
Tokyo, Japan
Investigational Site 6113
Tokyo, Japan
Investigational Site 6102
Tokyo, Japan
Investigational Site 6105
Tokyo, Japan
Investigational Site 6145
Tokyo, Japan
Investigational Site 6149
Tottori, Japan
Korea, Republic of
Investigational Site 4513
Busan, Korea, Republic of
Investigational Site 4509
Daegu, Korea, Republic of
Investigational Site 4501
Gyeonggi-do, Korea, Republic of
Investigational Site 4508
Seoul, Korea, Republic of
Investigational Site 4515
Seoul, Korea, Republic of
Investigational Site 4506
Seoul, Korea, Republic of
Investigational Site 4507
Seoul, Korea, Republic of
Mexico
Investigational Site 1303
Zapopan, Jalisco, Mexico
Investigational Site 1302
Monterrey, Nuevo Leon, Mexico
Investigational Site 1311
Col. Lomas Altas C.P, Mexico
Investigational Site 1312
Guadalajara, Mexico
Investigational Site 1304
Guadalajara, Mexico
Investigational Site 1300
Hermosillo, Mexico
Investigational Site 1305
Monterrey, Nuevo Leon, Mexico
Investigational Site 1308
San Luis Potosi, Mexico
Investigational Site 1301
Yucatan, Mexico
Netherlands
Investigational Site 3608
Alkmaar, Netherlands
Investigational Site 3607
Almere, 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
New Zealand
Investigational Site 4703
Auckland, New Zealand
Investigational Site 4702
Auckland, New Zealand
Investigational Site 4700
Christchurch, New Zealand
Investigational Site 4704
Wellington, New Zealand
Norway
Investigational Site 3701
Fredrikstad, Norway
Investigational Site 3700
Oslo, Norway
Philippines
Pasig City, Philippines
Investigational site 4801
Quezon City, Philippines
Investigational Site 4800
Quezon City, Philippines
Investigational Site 4802
Quezon City, Philippines
Poland
Investigational Site 5015
Bialystok, Poland
Investigational Site 5005
Krakow, Poland
Investigational Site 5019
Olsztyn, Poland
Investigational Site 5018
Tarnow, Poland
Investigational Site 5014
Warszawa, Poland
Investigational Site 5003
Warszawa, Poland
Investigational Site 5008
Warszawa, Poland
Investigational Site 5007
Warszawa, Poland
Russian Federation
Barnaul, Russian Federation
Investigational Site 3023
Chelyabinsk, Russian Federation
Investigational Site 3017
Irkutsk, Russian Federation
Investigational Site 3019
Kemerovo, Russian Federation
Investigational Site 3030
Krasnoyarsk, Russian Federation
Investigational Site 3020
Krasnoyarsk, Russian Federation
Investigational Site 3029
Moscow, Russian Federation
Investigational Site 3028
Novosibirsk, Russian Federation
Investigational Site 3009
Omsk, Russian Federation
Investigational Site 3022
Ryazan, Russian Federation
Saratov, Russian Federation
Investigational Site 3024
Sochi, Russian Federation
Investigational Site 3003
St. Petersburg, Russian Federation
Investigational Site 3000
St. Petersburg, Russian Federation
Investigational Site 3027
St. Petersburg, Russian Federation
Investigational Site 3025
Tyumen, Russian Federation
Investigational Site 3016
Ufa, Russian Federation
Investigational Site 3010
Yaroslavl, Russian Federation
Investigational Site 3004
Yaroslavl, Russian Federation
Singapore
Investigational Site 5900
Outram Road, Singapore
Investigational Site 5902
Singapore, Singapore
South Africa
Investigational Site 4912
Cape Town, South Africa
Investigational Site 4907
Centurion, South Africa
Investigational Site 4901
Johannesburg, South Africa
Investigational Site 4910
Johannesburg, South Africa
Investigational Site 4905
Johannesburg, South Africa
Investigational Site 4909
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
Spain
Investigational site 1503
Barcelona, Spain
Investigational Site 1502
Cabra, Spain
Sweden
Investigational Site 3900
Hallingsjo, Sweden
Investigational Site 3904
Kristianstad, Sweden
Investigational Site 3905
Stockholm, Sweden
Investigational Site 3903
Stockholm, Sweden
Investigational Site 3902
Sundsvall, Sweden
Switzerland
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
Luzern, Switzerland
Taiwan
Hualien City, Taiwan
Investigational Site 5104
Kaohsiung, Taiwan
Investigational Site 5105
Taichung, Taiwan
Investigational Site 5101
Taipei, Taiwan
Investigational Site 5103
Taipei, Taiwan
Thailand
Investigational Site 5200
Bangkok, Thailand
Investigational Site 5202
Bangkok, Thailand
Investigational Site 5203
Nakhorn Nayok, Thailand
Turkey
Investigational Site 5702
Ankara, Turkey
Investigational Site 5703
Ankara, Turkey
Investigational Site 5702
Istanbul, Turkey
Investigational Site 5706
Istanbul, Turkey
Ukraine
Chernigiv, 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
Uzhgorod, Ukraine
Investigational Site 4003
Vinnitsya, Ukraine
Investigational Site 4006
Zaporizhzhia, Ukraine
United Kingdom
Investigational Site 7005
Coventry, United Kingdom
Investigational Site 7006
Hull, United Kingdom
Investigational Site 7003
London, United Kingdom
Investigational Site 7004
London, United Kingdom
Investigational Site 7000
London, United Kingdom
Investigational Site 7001
Newcastle, United Kingdom
Investigational Site 7007
Plymouth, United Kingdom
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00986154     History of Changes
Other Study ID Numbers: DU176b-D-U305, The Edoxaban Hokusai VTE Study
Study First Received: September 25, 2009
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Recurrent Thrombosis
Recurrent Pulmonary Embolism
Symptomatic Deep Vein Thrombosis
Symptomatic Pulmonary Embolism
Venous Thromboembolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014