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).

Venous Thromboembolism Clinical Trial

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).

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
• 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
• 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

Related Conditions & MeSH terms

• Deep Vein Thrombosis (DVT)
• Embolism
• Pulmonary Embolism
• Pulmonary Embolism (PE)
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

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
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
Czechia	Investigational Site 1902	Liberec
Czechia	Investigational Site 1908	Olomouc
Czechia	Investigational Site 1905	Ostrava
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
Estonia	Investigational Site 2101	Tallinn
Estonia	Investigational Site 2102	Tartu
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 3307	Grenoble
France	Investigational Site 3322	Grenoble
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
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
Hungary	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	Kecskemet
Hungary	Investigational Site 5405	Kistarcsa
Hungary	Investigational Site 5407	Miskolc
Hungary	Investigational Site 5410	Pecs
Hungary	Investigational Site 5403	Szentes
Hungary	Investigational Site 5408	Szombathely
Hungary	Investigational Site 5412	Zalaegerszeg
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	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	Investigational Site 4420	Lucknow
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	Investigational Site 4470	Secunderbad
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
Italy	Investigational Site 3508	Bergamo
Italy	Investigational Site 3506	Chieti
Italy	Investigational Site 3500	Emilia
Italy	Investigational Site 3504	Milano
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
Japan	Investigational Site 6137	Aichi
Japan	Investigational Site 6104	Aomori
Japan	Investigational Site 6117	Chiba
Japan	Investigational Site 6119	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	Hyogo
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
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 4506	Seoul
Korea, Republic of	Investigational Site 4507	Seoul
Korea, Republic of	Investigational Site 4508	Seoul
Korea, Republic of	Investigational Site 4515	Seoul
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 1302	Monterrey	Nuevo Leon
Mexico	Investigational Site 1305	Monterrey, Nuevo Leon
Mexico	Investigational Site 1308	San Luis Potosi
Mexico	Investigational Site 1301	Yucatan
Mexico	Investigational Site 1303	Zapopan	Jalisco
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
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
Russian Federation	Investigational Site 3003	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 3004	Yaroslavl
Russian Federation	Investigational Site 3010	Yaroslavl
Singapore	Investigational Site 5900	Outram Road
Singapore	Investigational Site 5902	Singapore
South Africa	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
Spain	Investigational site 1503	Barcelona
Spain	Investigational Site 1502	Cabra
Sweden	Investigational Site 3900	Hallingsjo
Sweden	Investigational Site 3904	Kristianstad
Sweden	Investigational Site 3903	Stockholm
Sweden	Investigational Site 3905	Stockholm
Sweden	Investigational Site 3902	Sundsvall
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
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
Thailand	Investigational Site 5202	Bangkok
Thailand	Investigational Site 5203	Nakhorn Nayok
Turkey	Investigational Site 5702	Ankara
Turkey	Investigational Site 5703	Ankara
Turkey	Investigational Site 5702	Istanbul
Turkey	Investigational Site 5706	Istanbul
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
United Kingdom	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 States	Investigational Site 7104	Albany	Georgia
United States	Investigational Site 1070	Anaheim	California
United States	Investigational Site 1009	Arlington	Texas
United States	Investigational Site 1012	Aurora	Colorado
United States	Investigational Site 1068	Baltimore	Maryland
United States	Investigational Site 7152	Bend	Oregon
United States	Investigational Site 1013	Boulder	Colorado
United States	Investigational Site 7147	Butte	Montana
United States	Investigational Site 1004	Camp Hill	Pennsylvania
United States	Investigational Site 1071	Clearwater	Florida
United States	Investigational Site 1095	Columbus	Georgia
United States	Investigational Site 1065	Covington	Louisiana
United States	Investigational Site 1050	Dallas	Texas
United States	Investigational Site 1017	Denver	Colorado
United States	Investigational Site 7135	Durham	North Carolina
United States	Investigational Site 1031	Easley	South Carolina
United States	Investigational Site 7109	Ephrata	Pennsylvania
United States	Investigational Site 7117	Fort Myers	Florida
United States	Investigational Site 1047	Fort Worth	Texas
United States	Investigational Site 1048	Fort Worth	Texas
United States	Investigational Site 7105	Fort Worth	Texas
United States	Investigational Site 1003	Fredericksburg	Virginia
United States	Investigational Site 7106	Gainesville	Florida
United States	Investigational Site 1032	Greenville	South Carolina
United States	Investigational Site 1033	Greenville	South Carolina
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
United States	Investigational Site 7139	Little Rock	Arkansas
United States	Investigational Site 1019	Littleton	Colorado
United States	Investigational Site 7125	Los Alamitos	California
United States	Investigational Site 7138	Maumee	Ohio
United States	Investigational Site 1059	Midland	Texas
United States	Investigational Site 7103	Mobile	Alabama
United States	Investigational Site 1093	Monterey	California
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