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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00986154
Other study ID # DU176b-D-U305
Secondary ID The Edoxaban Hok
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2009
Est. completion date April 2013

Study information

Verified date March 2015
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8292
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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
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
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

Locations

Country Name City State
Argentina 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 Cordoba
Argentina Investigational Site 1110 Pcia De Corrientes
Argentina Investigational Site 1109 Santa Fe
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 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
Austria Investigational Site 2802 Feldkirch
Austria Investigational Site 2803 Graz
Austria Investigational Site 2800 Innsbruck
Austria Investigational Site 2804 Linz
Belarus Investigational Site 2703 Gomel
Belarus Investigational Site 2704 Grodno
Belarus Investigational Site 2700 Minsk
Belarus Investigational site 2701 Minsk
Belarus Investigational Site 2702 Minsk
Belarus Investigational Site 2705 Mogilev
Belgium Investigational Site 1608 Aalst
Belgium Investigational Site 1602 Lier
Brazil 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 Sao Bernardo do Campo
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 Sao Paulo
Canada Investigational Site 2006 Edmonton Alberta
Canada Investigational Site 2005 Halifax
Canada Investigational Site 2001 London Ontario
Canada Investigational Site 2004 Montreal
Canada Investigational Site 2007 Newmarket Ontario
Canada Investigational Site 2000 Ottawa Ontario
Canada Investigational Site 2003 Richmond Hill Ontario
Chile Investigational Site 1200 Santiago
Chile Investigational Site 1204 Santiago
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 Beijing
China Investigational Site 4316 Guangzhou
China Investigational Site 4310 Hangzhou
China Investigational Site 4325 Jiangsu
China Investigational Site 4317 Kunming
China Investigational Site 4328 Nanjing
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China Investigational Site 4313 Qingdao
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China Investigational Site 4324 Shanghai
China Investigational Site 4330 Shanghai
China Investigational Site 4335 Shanghai
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China Investigational Site 4320 Tianjin
China Investigational site 4338 Xi'an
China Investigational Site 4315 Yinchuan
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Czechia Investigational Site 1901 Plzen
Czechia Investigational Site 1910 Plzen
Czechia Investigational Site 1904 Praha
Denmark Investigational Site 6010 Aarhus
Denmark Investigational Site 6003 Herlev
Denmark Investigational Site 6001 Svendborg
Estonia Investigational Site 2100 Tallinn
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Estonia Investigational Site 2102 Tartu
France Investigational Site 3314 Agen
France Investigational Site 3302 Amiens
France Investigational Site 3311 Angers
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France Investigational Site 3325 Hetztessy
France Investigational Site 3328 Le Mans
France Investigational Site 3339 Lille
France Investigational Site 3318 Lyon
France Investigational Site 3303 Montpellier
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 Benite
France Investigational Site 3305 Saint-Etienne Cedex
France Investigational Site 3316 Toulon
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 Investigational Site 1712 Mainz
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Germany Investigational Site 1714 Nordhausen
Germany Investigational Site 1711 Paderborn
Germany Investigational Site 1706 Tubingen
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Hungary Investigational Site 5413 Baja
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India Investigational Site 4470 Secunderbad
Israel Investigational Site 5506 Haifa
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Israel Investigational Site 5500 Holon
Israel Investigational Site 5501 Jerusalem
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Israel Investigational Site 5513 Nahariya
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Israel Investigational Site 5503 Tel Aviv
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Italy Investigational Site 3508 Bergamo
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Japan Investigational Site 6137 Aichi
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Netherlands Investigational Site 3608 Alkmaar
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Netherlands Investigational Site 3611 Amsterdam
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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
New Zealand Investigational Site 4702 Auckland
New Zealand Investigational Site 4703 Auckland
New Zealand Investigational Site 4700 Christchurch
New Zealand Investigational Site 4704 Wellington
Norway Investigational Site 3701 Fredrikstad
Norway Investigational Site 3700 Oslo
Philippines Investigational Site 4800 Quezon City
Philippines Investigational site 4801 Quezon City
Philippines Investigational Site 4802 Quezon City
Poland Investigational Site 5015 Bialystok
Poland Investigational Site 5005 Krakow
Poland Investigational Site 5019 Olsztyn
Poland Investigational Site 5018 Tarnow
Poland Investigational Site 5003 Warszawa
Poland Investigational Site 5007 Warszawa
Poland Investigational Site 5008 Warszawa
Poland Investigational Site 5014 Warszawa
Russian Federation Investigational Site 3023 Chelyabinsk
Russian Federation Investigational Site 3017 Irkutsk
Russian Federation Investigational Site 3019 Kemerovo
Russian Federation Investigational Site 3020 Krasnoyarsk
Russian Federation Investigational Site 3030 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 Investigational Site 3024 Sochi
Russian Federation Investigational Site 3000 St. Petersburg
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Russian Federation Investigational Site 3027 St. Petersburg
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Russian Federation Investigational Site 3016 Ufa
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Singapore Investigational Site 5900 Outram Road
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South Africa Investigational Site 4912 Cape Town
South Africa Investigational Site 4907 Centurion
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South Africa Investigational Site 4905 Johannesburg
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South Africa Investigational Site 4906 Pretoria
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Spain Investigational site 1503 Barcelona
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Switzerland Investigational Site 4103 Aarau
Switzerland Investigational Site 4110 Basel
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Switzerland Investigational Site 4109 Lausanne
Switzerland Investigational Site 4100 Luzern
Taiwan Investigational Site 5104 Kaohsiung
Taiwan Investigational Site 5105 Taichung
Taiwan Investigational Site 5101 Taipei
Taiwan Investigational Site 5103 Taipei
Thailand Investigational Site 5200 Bangkok
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Thailand Investigational Site 5203 Nakhorn Nayok
Turkey Investigational Site 5702 Ankara
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Turkey Investigational Site 5702 Istanbul
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Ukraine Investigational Site 4008 Dnipropetrovsk
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United States Investigational Site 7105 Fort Worth Texas
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United States Investigational Site 7106 Gainesville Florida
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United States Investigational Site 1034 Greenville South Carolina
United States Investigational Site 1080 Jonesboro Georgia
United States Investigational Site 7133 Kansas City Missouri
United States Investigational Site 1049 Kingston Pennsylvania
United States Investigational Site 1018 Lakewood Colorado
United States Investigational Site 7109 Lancaster Pennsylvania
United States Investigational Site 1039 Las Vegas Nevada
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United States Investigational Site 1019 Littleton Colorado
United States Investigational Site 7125 Los Alamitos California
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United States Investigational Site 1059 Midland Texas
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United States Investigational Site 7132 Montgomery Alabama
United States Investigational Site 1040 New Braunfels Texas
United States Investigational Site 1025 Newport News Virginia
United States Investigational Site 1024 Norfolk Virginia
United States Investigational Site 1005 Ocoee Florida
United States Investigational Site 1041 Odessa Texas
United States Investigational Site 1006 Orlando Florida
United States Investigational Site 7115 Paducah Kentucky
United States Investigational Site 1069 Palm Springs California
United States Investigational Site 1098 Park Ridge Illinois
United States Investigational Site 7126 Phoenix Arizona
United States Investigational Site 1066 Randallstown Virginia
United States Investigational Site 7143 Rochester New York
United States Investigational Site 7127 Saint Petersburg Florida
United States Investigational Site 7123 Salt Lake City Utah
United States Investigational Site 1002 San Antonio Texas
United States Investigational Site 7150 San Diego California
United States Investigational Site 7144 Sarasota Florida
United States Investigational Site 7146 Savannah Georgia
United States Investigational Site 7120 Seattle Washington
United States Investigational Site 7154 Sellersville Pennsylvania
United States Investigational Site 1035 Seneca South Carolina
United States Investigational Site 1036 Spartanburg South Carolina
United States Investigational Site 7145 Statesville North Carolina
United States Investigational Site 1058 Sugar Land Texas
United States Investigational Site 1076 Tacoma Washington
United States Investigational Site 1022 Thornton Colorado
United States Investigational Site 1023 Thornton Colorado
United States Investigational Site 7122 Toledo Ohio
United States Investigational Site 1042 Tyler Texas
United States Investigational Site 7128 Uniontown Pennsylvania
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 1030 Virginia Beach Virginia
United States Investigational Site 1089 Vista California
United States Investigational Site 1008 Waco Texas
United States Investigational Site 1037 Westminster Maryland
United States Investigational Site 1038 Westminster Maryland
United States Investigational Site 1007 Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Daiichi Sankyo, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Canada,  Chile,  China,  Czechia,  Denmark,  Estonia,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Philippines,  Poland,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality 12 months from time of randomization
Secondary 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
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