Trial Review

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/ct2/show/NCT00986154




Registration number
NCT00986154
Ethics application status
Date submitted
25/09/2009
Date registered
29/09/2009
Date last updated
5/03/2019

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
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular 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
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
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
Sex
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
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
8292
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 4206 - Saint Leonards NSW
Recruitment hospital [10] 0 0
Investigational Site 4214 - South Brisbane
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
- Saint Leonards NSW
Recruitment postcode(s) [10] 0 0
- South Brisbane
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
Czechia
State/province [69] 0 0
Chodov
Country [70] 0 0
Czechia
State/province [70] 0 0
Jihlava
Country [71] 0 0
Czechia
State/province [71] 0 0
Liberec
Country [72] 0 0
Czechia
State/province [72] 0 0
Olomouc
Country [73] 0 0
Czechia
State/province [73] 0 0
Ostrava
Country [74] 0 0
Czechia
State/province [74] 0 0
Plzen
Country [75] 0 0
Czechia
State/province [75] 0 0
Praha
Country [76] 0 0
Czechia
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
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/ct2/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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00986154