Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming months in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00986154




Trial ID
NCT00986154
Ethics application status
Date submitted
25/09/2009
Date registered
28/09/2009
Date last updated
13/03/2015

Titles & IDs
Public title
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).
Scientific 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).
Secondary ID [1] 0 0
The Edoxaban Hokusai VTE Study
Secondary ID [2] 0 0
DU176b-D-U305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Deep Vein Thrombosis (DVT) 0 0
Pulmonary Embolism (PE) 0 0
Thromboembolism 0 0
Venous Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - edoxaban tosylate(DU-176b)
Treatment: Drugs - low molecular weight heparin/unfractionated heparin
Treatment: Drugs - warfarin

Experimental: heparin/edoxaban tosylate -

Active Comparator: heparin/warfarin -


Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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."
Timepoint [1] 0 0
12 months from time of randomization
Secondary outcome [1] 0 0
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
Timepoint [1] 0 0
12 months from time of randomization
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
12 months from time of randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site 4205 - Bedford Park
Recruitment hospital [2] 0 0
Investigational Site 4209 - Box Hill
Recruitment hospital [3] 0 0
Investigational Site 4210 - Clayton
Recruitment hospital [4] 0 0
Investigational Site 4211 - Fremantle
Recruitment hospital [5] 0 0
Investigational Site 4213 - Garran
Recruitment hospital [6] 0 0
- Kogarah
Recruitment hospital [7] 0 0
Investigational Site 4207 - Perth
Recruitment hospital [8] 0 0
Investigational Site 4203 - Redcliffe
Recruitment hospital [9] 0 0
Investigational Site 4214 - South Brisbane
Recruitment hospital [10] 0 0
Investigational Site 4206 - St. Leonards NSW
Recruitment hospital [11] 0 0
Investigational Site 4212 - Westmead NSW
Recruitment hospital [12] 0 0
Investigational Site 4200 - Windsor
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment postcode(s) [5] 0 0
- Garran
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment postcode(s) [8] 0 0
- Redcliffe
Recruitment postcode(s) [9] 0 0
- South Brisbane
Recruitment postcode(s) [10] 0 0
- St. Leonards NSW
Recruitment postcode(s) [11] 0 0
- Westmead NSW
Recruitment postcode(s) [12] 0 0
- Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Cordoba
Country [28] 0 0
Argentina
State/province [28] 0 0
Pcia De Corrientes
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Austria
State/province [30] 0 0
Feldkirch
Country [31] 0 0
Austria
State/province [31] 0 0
Graz
Country [32] 0 0
Austria
State/province [32] 0 0
Innsbruck
Country [33] 0 0
Austria
State/province [33] 0 0
Linz
Country [34] 0 0
Austria
State/province [34] 0 0
Sr. M. Restitutagasse
Country [35] 0 0
Austria
State/province [35] 0 0
Vienna
Country [36] 0 0
Belarus
State/province [36] 0 0
Gomel
Country [37] 0 0
Belarus
State/province [37] 0 0
Grodno
Country [38] 0 0
Belarus
State/province [38] 0 0
Minsk
Country [39] 0 0
Belarus
State/province [39] 0 0
Mogilev
Country [40] 0 0
Belgium
State/province [40] 0 0
Aalst
Country [41] 0 0
Belgium
State/province [41] 0 0
Lier
Country [42] 0 0
Brazil
State/province [42] 0 0
Belo Horizonte
Country [43] 0 0
Brazil
State/province [43] 0 0
Campinas
Country [44] 0 0
Brazil
State/province [44] 0 0
Curitiba
Country [45] 0 0
Brazil
State/province [45] 0 0
Porto Alegre
Country [46] 0 0
Brazil
State/province [46] 0 0
Sao Bernardo do Campo
Country [47] 0 0
Brazil
State/province [47] 0 0
Sao Paulo
Country [48] 0 0
Canada
State/province [48] 0 0
Alberta
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Halifax
Country [51] 0 0
Canada
State/province [51] 0 0
Montreal
Country [52] 0 0
Chile
State/province [52] 0 0
Santiago
Country [53] 0 0
China
State/province [53] 0 0
Beijing
Country [54] 0 0
China
State/province [54] 0 0
Guangzhou
Country [55] 0 0
China
State/province [55] 0 0
Hangzhou
Country [56] 0 0
China
State/province [56] 0 0
Hebei Province
Country [57] 0 0
China
State/province [57] 0 0
Jiangsu
Country [58] 0 0
China
State/province [58] 0 0
Kunming
Country [59] 0 0
China
State/province [59] 0 0
Nanjing
Country [60] 0 0
China
State/province [60] 0 0
Nanning
Country [61] 0 0
China
State/province [61] 0 0
Qingdao
Country [62] 0 0
China
State/province [62] 0 0
Shanghai
Country [63] 0 0
China
State/province [63] 0 0
Shenyang
Country [64] 0 0
China
State/province [64] 0 0
Sichuan Province
Country [65] 0 0
China
State/province [65] 0 0
Taiyuan
Country [66] 0 0
China
State/province [66] 0 0
Tianjin
Country [67] 0 0
China
State/province [67] 0 0
Xi'an
Country [68] 0 0
China
State/province [68] 0 0
Yinchuan
Country [69] 0 0
Czech Republic
State/province [69] 0 0
Chodov
Country [70] 0 0
Czech Republic
State/province [70] 0 0
Jihlava
Country [71] 0 0
Czech Republic
State/province [71] 0 0
Liberec
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Olomouc
Country [73] 0 0
Czech Republic
State/province [73] 0 0
Ostrava
Country [74] 0 0
Czech Republic
State/province [74] 0 0
Plzen
Country [75] 0 0
Czech Republic
State/province [75] 0 0
Praha
Country [76] 0 0
Czech Republic
State/province [76] 0 0
Usti Nad Labem
Country [77] 0 0
Denmark
State/province [77] 0 0
Aarhus
Country [78] 0 0
Denmark
State/province [78] 0 0
Arhus N.
Country [79] 0 0
Denmark
State/province [79] 0 0
Copenhagen
Country [80] 0 0
Denmark
State/province [80] 0 0
Herlev
Country [81] 0 0
Denmark
State/province [81] 0 0
Ringvej
Country [82] 0 0
Denmark
State/province [82] 0 0
Svendborg
Country [83] 0 0
Estonia
State/province [83] 0 0
Tallinn
Country [84] 0 0
Estonia
State/province [84] 0 0
Tartu
Country [85] 0 0
France
State/province [85] 0 0
Agen
Country [86] 0 0
France
State/province [86] 0 0
Amiens
Country [87] 0 0
France
State/province [87] 0 0
Angers
Country [88] 0 0
France
State/province [88] 0 0
Annecy
Country [89] 0 0
France
State/province [89] 0 0
Arras
Country [90] 0 0
France
State/province [90] 0 0
Besancon Cedex
Country [91] 0 0
France
State/province [91] 0 0
Bordeaux
Country [92] 0 0
France
State/province [92] 0 0
Brest
Country [93] 0 0
France
State/province [93] 0 0
Cannes
Country [94] 0 0
France
State/province [94] 0 0
Colombes Cedex
Country [95] 0 0
France
State/province [95] 0 0
Dijon
Country [96] 0 0
France
State/province [96] 0 0
Grenoble
Country [97] 0 0
France
State/province [97] 0 0
Hetztessy
Country [98] 0 0
France
State/province [98] 0 0
Le Mans
Country [99] 0 0
France
State/province [99] 0 0
Lille
Country [100] 0 0
France
State/province [100] 0 0
Lormont
Country [101] 0 0
France
State/province [101] 0 0
Lyon
Country [102] 0 0
France
State/province [102] 0 0
Montpellier
Country [103] 0 0
France
State/province [103] 0 0
Nantes
Country [104] 0 0
France
State/province [104] 0 0
Nice
Country [105] 0 0
France
State/province [105] 0 0
Paris
Country [106] 0 0
France
State/province [106] 0 0
Pessac
Country [107] 0 0
France
State/province [107] 0 0
Pierre Benite
Country [108] 0 0
France
State/province [108] 0 0
Roskilde
Country [109] 0 0
France
State/province [109] 0 0
Saint Aubin Surscie
Country [110] 0 0
France
State/province [110] 0 0
Saint-Etienne Cedex
Country [111] 0 0
France
State/province [111] 0 0
Toulon
Country [112] 0 0
Germany
State/province [112] 0 0
Berlin
Country [113] 0 0
Germany
State/province [113] 0 0
Bielefeld
Country [114] 0 0
Germany
State/province [114] 0 0
Bruchsal
Country [115] 0 0
Germany
State/province [115] 0 0
Darmstadt
Country [116] 0 0
Germany
State/province [116] 0 0
Dortmund
Country [117] 0 0
Germany
State/province [117] 0 0
Dresden
Country [118] 0 0
Germany
State/province [118] 0 0
Hamburg
Country [119] 0 0
Germany
State/province [119] 0 0
Magdeburg
Country [120] 0 0
Germany
State/province [120] 0 0
Mainz
Country [121] 0 0
Germany
State/province [121] 0 0
Munchen
Country [122] 0 0
Germany
State/province [122] 0 0
Nordhausen
Country [123] 0 0
Germany
State/province [123] 0 0
Paderborn
Country [124] 0 0
Germany
State/province [124] 0 0
Tubingen
Country [125] 0 0
Germany
State/province [125] 0 0
Witten
Country [126] 0 0
Hungary
State/province [126] 0 0
Baja
Country [127] 0 0
Hungary
State/province [127] 0 0
Budapest
Country [128] 0 0
Hungary
State/province [128] 0 0
Debrecen
Country [129] 0 0
Hungary
State/province [129] 0 0
Kecskemet
Country [130] 0 0
Hungary
State/province [130] 0 0
Kistarcsa
Country [131] 0 0
Hungary
State/province [131] 0 0
Maglodi
Country [132] 0 0
Hungary
State/province [132] 0 0
Miskolc
Country [133] 0 0
Hungary
State/province [133] 0 0
Pecs
Country [134] 0 0
Hungary
State/province [134] 0 0
Rakoczi
Country [135] 0 0
Hungary
State/province [135] 0 0
Szentes
Country [136] 0 0
Hungary
State/province [136] 0 0
Szombathely
Country [137] 0 0
Hungary
State/province [137] 0 0
Zalaegerszeg
Country [138] 0 0
Hungary
State/province [138] 0 0
Zrinyi
Country [139] 0 0
India
State/province [139] 0 0
Ahmedabad
Country [140] 0 0
India
State/province [140] 0 0
Andhra Pradesh
Country [141] 0 0
India
State/province [141] 0 0
Bangalore
Country [142] 0 0
India
State/province [142] 0 0
Gujarat
Country [143] 0 0
India
State/province [143] 0 0
Gurgaon
Country [144] 0 0
India
State/province [144] 0 0
Haryana
Country [145] 0 0
India
State/province [145] 0 0
Holon
Country [146] 0 0
India
State/province [146] 0 0
Hyderabad
Country [147] 0 0
India
State/province [147] 0 0
Karnataka
Country [148] 0 0
India
State/province [148] 0 0
Kerala
Country [149] 0 0
India
State/province [149] 0 0
Lucknow
Country [150] 0 0
India
State/province [150] 0 0
Madhya Pradesh
Country [151] 0 0
India
State/province [151] 0 0
Maharashtra
Country [152] 0 0
India
State/province [152] 0 0
Mumbai
Country [153] 0 0
India
State/province [153] 0 0
New Delhi
Country [154] 0 0
India
State/province [154] 0 0
Pune
Country [155] 0 0
India
State/province [155] 0 0
Punjab
Country [156] 0 0
India
State/province [156] 0 0
Rajasthan
Country [157] 0 0
India
State/province [157] 0 0
Secunderbad
Country [158] 0 0
India
State/province [158] 0 0
Tamil Nadu
Country [159] 0 0
India
State/province [159] 0 0
Uttar Pradesh
Country [160] 0 0
India
State/province [160] 0 0
Vadodara
Country [161] 0 0
India
State/province [161] 0 0
Visakhapatnam
Country [162] 0 0
Israel
State/province [162] 0 0
Afula
Country [163] 0 0
Israel
State/province [163] 0 0
Ashkelon
Country [164] 0 0
Israel
State/province [164] 0 0
Hadera
Country [165] 0 0
Israel
State/province [165] 0 0
Haifa
Country [166] 0 0
Israel
State/province [166] 0 0
Holon
Country [167] 0 0
Israel
State/province [167] 0 0
Jerusalem
Country [168] 0 0
Israel
State/province [168] 0 0
Kfar Saba
Country [169] 0 0
Israel
State/province [169] 0 0
Nahariya
Country [170] 0 0
Israel
State/province [170] 0 0
Petah-Tikva
Country [171] 0 0
Israel
State/province [171] 0 0
Poriya
Country [172] 0 0
Israel
State/province [172] 0 0
Tel Aviv
Country [173] 0 0
Israel
State/province [173] 0 0
Tel Hashomer
Country [174] 0 0
Italy
State/province [174] 0 0
Bergamo
Country [175] 0 0
Italy
State/province [175] 0 0
Chieti
Country [176] 0 0
Italy
State/province [176] 0 0
Emilia
Country [177] 0 0
Italy
State/province [177] 0 0
Milano
Country [178] 0 0
Italy
State/province [178] 0 0
Padova
Country [179] 0 0
Italy
State/province [179] 0 0
Palermo
Country [180] 0 0
Italy
State/province [180] 0 0
Parma
Country [181] 0 0
Italy
State/province [181] 0 0
Pavia
Country [182] 0 0
Italy
State/province [182] 0 0
Rozzano
Country [183] 0 0
Italy
State/province [183] 0 0
Udine
Country [184] 0 0
Italy
State/province [184] 0 0
Varese
Country [185] 0 0
Italy
State/province [185] 0 0
Venezia
Country [186] 0 0
Japan
State/province [186] 0 0
Aichi
Country [187] 0 0
Japan
State/province [187] 0 0
Aomori
Country [188] 0 0
Japan
State/province [188] 0 0
Chiba
Country [189] 0 0
Japan
State/province [189] 0 0
Fukuoka
Country [190] 0 0
Japan
State/province [190] 0 0
Fukushima
Country [191] 0 0
Japan
State/province [191] 0 0
Hiroshima
Country [192] 0 0
Japan
State/province [192] 0 0
Hokkaido
Country [193] 0 0
Japan
State/province [193] 0 0
Hyogo
Country [194] 0 0
Japan
State/province [194] 0 0
Ishikawa
Country [195] 0 0
Japan
State/province [195] 0 0
Kagoshima
Country [196] 0 0
Japan
State/province [196] 0 0
Kanagawa
Country [197] 0 0
Japan
State/province [197] 0 0
Kumamoto
Country [198] 0 0
Japan
State/province [198] 0 0
Mie
Country [199] 0 0
Japan
State/province [199] 0 0
Nagano
Country [200] 0 0
Japan
State/province [200] 0 0
Nagasaki
Country [201] 0 0
Japan
State/province [201] 0 0
Niigata
Country [202] 0 0
Japan
State/province [202] 0 0
Okayama
Country [203] 0 0
Japan
State/province [203] 0 0
Okinawa
Country [204] 0 0
Japan
State/province [204] 0 0
Osaka
Country [205] 0 0
Japan
State/province [205] 0 0
Sapporo
Country [206] 0 0
Japan
State/province [206] 0 0
Shizuoka
Country [207] 0 0
Japan
State/province [207] 0 0
Tokyo
Country [208] 0 0
Japan
State/province [208] 0 0
Tottori
Country [209] 0 0
Korea, Republic of
State/province [209] 0 0
Busan
Country [210] 0 0
Korea, Republic of
State/province [210] 0 0
Daegu
Country [211] 0 0
Korea, Republic of
State/province [211] 0 0
Gyeonggi-do
Country [212] 0 0
Korea, Republic of
State/province [212] 0 0
Seoul
Country [213] 0 0
Mexico
State/province [213] 0 0
Jalisco
Country [214] 0 0
Mexico
State/province [214] 0 0
Nuevo Leon
Country [215] 0 0
Mexico
State/province [215] 0 0
Col. Lomas Altas C.P
Country [216] 0 0
Mexico
State/province [216] 0 0
Guadalajara
Country [217] 0 0
Mexico
State/province [217] 0 0
Hermosillo
Country [218] 0 0
Mexico
State/province [218] 0 0
Monterrey, Nuevo Leon
Country [219] 0 0
Mexico
State/province [219] 0 0
San Luis Potosi
Country [220] 0 0
Mexico
State/province [220] 0 0
Yucatan
Country [221] 0 0
Netherlands
State/province [221] 0 0
Alkmaar
Country [222] 0 0
Netherlands
State/province [222] 0 0
Almere
Country [223] 0 0
Netherlands
State/province [223] 0 0
Amersfoort
Country [224] 0 0
Netherlands
State/province [224] 0 0
Amsterdam
Country [225] 0 0
Netherlands
State/province [225] 0 0
Assen
Country [226] 0 0
Netherlands
State/province [226] 0 0
Groningen
Country [227] 0 0
Netherlands
State/province [227] 0 0
Heerlen
Country [228] 0 0
Netherlands
State/province [228] 0 0
Hoofddorp
Country [229] 0 0
Netherlands
State/province [229] 0 0
Nijmegen
Country [230] 0 0
Netherlands
State/province [230] 0 0
Rotterdam
Country [231] 0 0
New Zealand
State/province [231] 0 0
Auckland
Country [232] 0 0
New Zealand
State/province [232] 0 0
Christchurch
Country [233] 0 0
New Zealand
State/province [233] 0 0
Wellington
Country [234] 0 0
Norway
State/province [234] 0 0
Fredrikstad
Country [235] 0 0
Norway
State/province [235] 0 0
Oslo
Country [236] 0 0
Philippines
State/province [236] 0 0
Pasig City
Country [237] 0 0
Philippines
State/province [237] 0 0
Quezon City
Country [238] 0 0
Poland
State/province [238] 0 0
Bialystok
Country [239] 0 0
Poland
State/province [239] 0 0
Krakow
Country [240] 0 0
Poland
State/province [240] 0 0
Olsztyn
Country [241] 0 0
Poland
State/province [241] 0 0
Tarnow
Country [242] 0 0
Poland
State/province [242] 0 0
Warszawa
Country [243] 0 0
Russian Federation
State/province [243] 0 0
Barnaul
Country [244] 0 0
Russian Federation
State/province [244] 0 0
Chelyabinsk
Country [245] 0 0
Russian Federation
State/province [245] 0 0
Irkutsk
Country [246] 0 0
Russian Federation
State/province [246] 0 0
Kemerovo
Country [247] 0 0
Russian Federation
State/province [247] 0 0
Krasnoyarsk
Country [248] 0 0
Russian Federation
State/province [248] 0 0
Moscow
Country [249] 0 0
Russian Federation
State/province [249] 0 0
Novosibirsk
Country [250] 0 0
Russian Federation
State/province [250] 0 0
Omsk
Country [251] 0 0
Russian Federation
State/province [251] 0 0
Ryazan
Country [252] 0 0
Russian Federation
State/province [252] 0 0
Saratov
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Sochi
Country [254] 0 0
Russian Federation
State/province [254] 0 0
St. Petersburg
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Tyumen
Country [256] 0 0
Russian Federation
State/province [256] 0 0
Ufa
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Yaroslavl
Country [258] 0 0
Singapore
State/province [258] 0 0
Outram Road
Country [259] 0 0
Singapore
State/province [259] 0 0
Singapore
Country [260] 0 0
South Africa
State/province [260] 0 0
Cape Town
Country [261] 0 0
South Africa
State/province [261] 0 0
Centurion
Country [262] 0 0
South Africa
State/province [262] 0 0
Johannesburg
Country [263] 0 0
South Africa
State/province [263] 0 0
Lyttleton
Country [264] 0 0
South Africa
State/province [264] 0 0
Pretoria
Country [265] 0 0
South Africa
State/province [265] 0 0
Somerset West
Country [266] 0 0
South Africa
State/province [266] 0 0
Worcester
Country [267] 0 0
Spain
State/province [267] 0 0
Barcelona
Country [268] 0 0
Spain
State/province [268] 0 0
Cabra
Country [269] 0 0
Sweden
State/province [269] 0 0
Hallingsjo
Country [270] 0 0
Sweden
State/province [270] 0 0
Kristianstad
Country [271] 0 0
Sweden
State/province [271] 0 0
Stockholm
Country [272] 0 0
Sweden
State/province [272] 0 0
Sundsvall
Country [273] 0 0
Switzerland
State/province [273] 0 0
Aarau
Country [274] 0 0
Switzerland
State/province [274] 0 0
Basel
Country [275] 0 0
Switzerland
State/province [275] 0 0
Bellinzona
Country [276] 0 0
Switzerland
State/province [276] 0 0
Chur
Country [277] 0 0
Switzerland
State/province [277] 0 0
Lausanne
Country [278] 0 0
Switzerland
State/province [278] 0 0
Luzern
Country [279] 0 0
Taiwan
State/province [279] 0 0
Hualien City
Country [280] 0 0
Taiwan
State/province [280] 0 0
Kaohsiung
Country [281] 0 0
Taiwan
State/province [281] 0 0
Taichung
Country [282] 0 0
Taiwan
State/province [282] 0 0
Taipei
Country [283] 0 0
Thailand
State/province [283] 0 0
Bangkok
Country [284] 0 0
Thailand
State/province [284] 0 0
Nakhorn Nayok
Country [285] 0 0
Turkey
State/province [285] 0 0
Ankara
Country [286] 0 0
Turkey
State/province [286] 0 0
Istanbul
Country [287] 0 0
Ukraine
State/province [287] 0 0
Chernigiv
Country [288] 0 0
Ukraine
State/province [288] 0 0
Dnipropetrovsk
Country [289] 0 0
Ukraine
State/province [289] 0 0
Donetsk
Country [290] 0 0
Ukraine
State/province [290] 0 0
Ivano-Frankivsk
Country [291] 0 0
Ukraine
State/province [291] 0 0
Kharkiv
Country [292] 0 0
Ukraine
State/province [292] 0 0
Kiev
Country [293] 0 0
Ukraine
State/province [293] 0 0
Ternopil
Country [294] 0 0
Ukraine
State/province [294] 0 0
Uzhgorod
Country [295] 0 0
Ukraine
State/province [295] 0 0
Vinnitsya
Country [296] 0 0
Ukraine
State/province [296] 0 0
Zaporizhzhia
Country [297] 0 0
United Kingdom
State/province [297] 0 0
Coventry
Country [298] 0 0
United Kingdom
State/province [298] 0 0
Hull
Country [299] 0 0
United Kingdom
State/province [299] 0 0
London
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Newcastle
Country [301] 0 0
United Kingdom
State/province [301] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00986154
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries