Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/study/NCT00986154
Registration number
NCT00986154
Ethics application status
Date submitted
25/09/2009
Date registered
29/09/2009
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).
Query!
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).
Query!
Secondary ID [1]
0
0
The Edoxaban Hokusai VTE Study
Query!
Secondary ID [2]
0
0
DU176b-D-U305
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
0
0
Query!
Deep Vein Thrombosis (DVT)
0
0
Query!
Pulmonary Embolism (PE)
0
0
Query!
Thromboembolism
0
0
Query!
Venous Thrombosis
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
Query!
Assessment method [1]
0
0
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."
Query!
Timepoint [1]
0
0
12 months from time of randomization
Query!
Secondary outcome [1]
0
0
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
12 months from time of randomization
Query!
Secondary outcome [2]
0
0
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
12 months from time of randomization
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
8292
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigational Site 4205 - Bedford Park
Query!
Recruitment hospital [2]
0
0
Investigational Site 4209 - Box Hill
Query!
Recruitment hospital [3]
0
0
Investigational Site 4210 - Clayton
Query!
Recruitment hospital [4]
0
0
Investigational Site 4211 - Fremantle
Query!
Recruitment hospital [5]
0
0
Investigational Site 4213 - Garran
Query!
Recruitment hospital [6]
0
0
- Kogarah
Query!
Recruitment hospital [7]
0
0
Investigational Site 4207 - Perth
Query!
Recruitment hospital [8]
0
0
Investigational Site 4203 - Redcliffe
Query!
Recruitment hospital [9]
0
0
Investigational Site 4206 - Saint Leonards NSW
Query!
Recruitment hospital [10]
0
0
Investigational Site 4214 - South Brisbane
Query!
Recruitment hospital [11]
0
0
Investigational Site 4212 - Westmead NSW
Query!
Recruitment hospital [12]
0
0
Investigational Site 4200 - Windsor
Query!
Recruitment postcode(s) [1]
0
0
- Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
- Box Hill
Query!
Recruitment postcode(s) [3]
0
0
- Clayton
Query!
Recruitment postcode(s) [4]
0
0
- Fremantle
Query!
Recruitment postcode(s) [5]
0
0
- Garran
Query!
Recruitment postcode(s) [6]
0
0
- Kogarah
Query!
Recruitment postcode(s) [7]
0
0
- Perth
Query!
Recruitment postcode(s) [8]
0
0
- Redcliffe
Query!
Recruitment postcode(s) [9]
0
0
- Saint Leonards NSW
Query!
Recruitment postcode(s) [10]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [11]
0
0
- Westmead NSW
Query!
Recruitment postcode(s) [12]
0
0
- Windsor
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Montana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nevada
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oregon
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Utah
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Virginia
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Washington
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Buenos Aires
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Cordoba
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Pcia De Corrientes
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Santa Fe
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Feldkirch
Query!
Country [31]
0
0
Austria
Query!
State/province [31]
0
0
Graz
Query!
Country [32]
0
0
Austria
Query!
State/province [32]
0
0
Innsbruck
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Linz
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Sr. M. Restitutagasse
Query!
Country [35]
0
0
Austria
Query!
State/province [35]
0
0
Vienna
Query!
Country [36]
0
0
Belarus
Query!
State/province [36]
0
0
Gomel
Query!
Country [37]
0
0
Belarus
Query!
State/province [37]
0
0
Grodno
Query!
Country [38]
0
0
Belarus
Query!
State/province [38]
0
0
Minsk
Query!
Country [39]
0
0
Belarus
Query!
State/province [39]
0
0
Mogilev
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Aalst
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Lier
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Belo Horizonte
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Campinas
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Curitiba
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Porto Alegre
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Sao Bernardo do Campo
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Sao Paulo
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Alberta
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Ontario
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Halifax
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Montreal
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Santiago
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Beijing
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Guangzhou
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Hangzhou
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Hebei Province
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Jiangsu
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Kunming
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Nanjing
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Nanning
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Qingdao
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Shanghai
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Shenyang
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Sichuan Province
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Taiyuan
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Tianjin
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Xi'an
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Yinchuan
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Chodov
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Jihlava
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Liberec
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Olomouc
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Ostrava
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Plzen
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Praha
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Usti Nad Labem
Query!
Country [77]
0
0
Denmark
Query!
State/province [77]
0
0
Aarhus
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Arhus N.
Query!
Country [79]
0
0
Denmark
Query!
State/province [79]
0
0
Copenhagen
Query!
Country [80]
0
0
Denmark
Query!
State/province [80]
0
0
Herlev
Query!
Country [81]
0
0
Denmark
Query!
State/province [81]
0
0
Ringvej
Query!
Country [82]
0
0
Denmark
Query!
State/province [82]
0
0
Svendborg
Query!
Country [83]
0
0
Estonia
Query!
State/province [83]
0
0
Tallinn
Query!
Country [84]
0
0
Estonia
Query!
State/province [84]
0
0
Tartu
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Agen
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Amiens
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Angers
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Annecy
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Arras
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Besancon Cedex
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Bordeaux
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Brest
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Cannes
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Colombes Cedex
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Dijon
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Grenoble
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Hetztessy
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Le Mans
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Lille
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Lormont
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Lyon
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Montpellier
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Nantes
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Nice
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Paris
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
Pessac
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Pierre Benite
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Roskilde
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Saint Aubin Surscie
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Saint-Etienne Cedex
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Toulon
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Berlin
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Bielefeld
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Bruchsal
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Darmstadt
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Dortmund
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Dresden
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Hamburg
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Magdeburg
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Mainz
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Munchen
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Nordhausen
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Paderborn
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Tubingen
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Witten
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Baja
Query!
Country [127]
0
0
Hungary
Query!
State/province [127]
0
0
Budapest
Query!
Country [128]
0
0
Hungary
Query!
State/province [128]
0
0
Debrecen
Query!
Country [129]
0
0
Hungary
Query!
State/province [129]
0
0
Kecskemet
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Kistarcsa
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Maglodi
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Miskolc
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Pecs
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Rakoczi
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Szentes
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Szombathely
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Zalaegerszeg
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Zrinyi
Query!
Country [139]
0
0
India
Query!
State/province [139]
0
0
Ahmedabad
Query!
Country [140]
0
0
India
Query!
State/province [140]
0
0
Andhra Pradesh
Query!
Country [141]
0
0
India
Query!
State/province [141]
0
0
Bangalore
Query!
Country [142]
0
0
India
Query!
State/province [142]
0
0
Gujarat
Query!
Country [143]
0
0
India
Query!
State/province [143]
0
0
Gurgaon
Query!
Country [144]
0
0
India
Query!
State/province [144]
0
0
Haryana
Query!
Country [145]
0
0
India
Query!
State/province [145]
0
0
Holon
Query!
Country [146]
0
0
India
Query!
State/province [146]
0
0
Hyderabad
Query!
Country [147]
0
0
India
Query!
State/province [147]
0
0
Karnataka
Query!
Country [148]
0
0
India
Query!
State/province [148]
0
0
Kerala
Query!
Country [149]
0
0
India
Query!
State/province [149]
0
0
Lucknow
Query!
Country [150]
0
0
India
Query!
State/province [150]
0
0
Madhya Pradesh
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Maharashtra
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Mumbai
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
New Delhi
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Pune
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
Punjab
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
Rajasthan
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
Secunderbad
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
Tamil Nadu
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Uttar Pradesh
Query!
Country [160]
0
0
India
Query!
State/province [160]
0
0
Vadodara
Query!
Country [161]
0
0
India
Query!
State/province [161]
0
0
Visakhapatnam
Query!
Country [162]
0
0
Israel
Query!
State/province [162]
0
0
Afula
Query!
Country [163]
0
0
Israel
Query!
State/province [163]
0
0
Ashkelon
Query!
Country [164]
0
0
Israel
Query!
State/province [164]
0
0
Hadera
Query!
Country [165]
0
0
Israel
Query!
State/province [165]
0
0
Haifa
Query!
Country [166]
0
0
Israel
Query!
State/province [166]
0
0
Holon
Query!
Country [167]
0
0
Israel
Query!
State/province [167]
0
0
Jerusalem
Query!
Country [168]
0
0
Israel
Query!
State/province [168]
0
0
Kfar Saba
Query!
Country [169]
0
0
Israel
Query!
State/province [169]
0
0
Nahariya
Query!
Country [170]
0
0
Israel
Query!
State/province [170]
0
0
Petah-Tikva
Query!
Country [171]
0
0
Israel
Query!
State/province [171]
0
0
Poriya
Query!
Country [172]
0
0
Israel
Query!
State/province [172]
0
0
Tel Aviv
Query!
Country [173]
0
0
Israel
Query!
State/province [173]
0
0
Tel Hashomer
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Bergamo
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Chieti
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Emilia
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Milano
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Padova
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Palermo
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Parma
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Pavia
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Rozzano
Query!
Country [183]
0
0
Italy
Query!
State/province [183]
0
0
Udine
Query!
Country [184]
0
0
Italy
Query!
State/province [184]
0
0
Varese
Query!
Country [185]
0
0
Italy
Query!
State/province [185]
0
0
Venezia
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Aichi
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Aomori
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Chiba
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Fukuoka
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Fukushima
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Hiroshima
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Hokkaido
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Hyogo
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Ishikawa
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Kagoshima
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Kanagawa
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Kumamoto
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Mie
Query!
Country [199]
0
0
Japan
Query!
State/province [199]
0
0
Nagano
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Nagasaki
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Niigata
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Okayama
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Okinawa
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Osaka
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Sapporo
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Shizuoka
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Tokyo
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Tottori
Query!
Country [209]
0
0
Korea, Republic of
Query!
State/province [209]
0
0
Busan
Query!
Country [210]
0
0
Korea, Republic of
Query!
State/province [210]
0
0
Daegu
Query!
Country [211]
0
0
Korea, Republic of
Query!
State/province [211]
0
0
Gyeonggi-do
Query!
Country [212]
0
0
Korea, Republic of
Query!
State/province [212]
0
0
Seoul
Query!
Country [213]
0
0
Mexico
Query!
State/province [213]
0
0
Jalisco
Query!
Country [214]
0
0
Mexico
Query!
State/province [214]
0
0
Nuevo Leon
Query!
Country [215]
0
0
Mexico
Query!
State/province [215]
0
0
Col. Lomas Altas C.P
Query!
Country [216]
0
0
Mexico
Query!
State/province [216]
0
0
Guadalajara
Query!
Country [217]
0
0
Mexico
Query!
State/province [217]
0
0
Hermosillo
Query!
Country [218]
0
0
Mexico
Query!
State/province [218]
0
0
Monterrey, Nuevo Leon
Query!
Country [219]
0
0
Mexico
Query!
State/province [219]
0
0
San Luis Potosi
Query!
Country [220]
0
0
Mexico
Query!
State/province [220]
0
0
Yucatan
Query!
Country [221]
0
0
Netherlands
Query!
State/province [221]
0
0
Alkmaar
Query!
Country [222]
0
0
Netherlands
Query!
State/province [222]
0
0
Almere
Query!
Country [223]
0
0
Netherlands
Query!
State/province [223]
0
0
Amersfoort
Query!
Country [224]
0
0
Netherlands
Query!
State/province [224]
0
0
Amsterdam
Query!
Country [225]
0
0
Netherlands
Query!
State/province [225]
0
0
Assen
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Groningen
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Heerlen
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Hoofddorp
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Nijmegen
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Rotterdam
Query!
Country [231]
0
0
New Zealand
Query!
State/province [231]
0
0
Auckland
Query!
Country [232]
0
0
New Zealand
Query!
State/province [232]
0
0
Christchurch
Query!
Country [233]
0
0
New Zealand
Query!
State/province [233]
0
0
Wellington
Query!
Country [234]
0
0
Norway
Query!
State/province [234]
0
0
Fredrikstad
Query!
Country [235]
0
0
Norway
Query!
State/province [235]
0
0
Oslo
Query!
Country [236]
0
0
Philippines
Query!
State/province [236]
0
0
Pasig City
Query!
Country [237]
0
0
Philippines
Query!
State/province [237]
0
0
Quezon City
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Bialystok
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Krakow
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Olsztyn
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Tarnow
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Warszawa
Query!
Country [243]
0
0
Russian Federation
Query!
State/province [243]
0
0
Barnaul
Query!
Country [244]
0
0
Russian Federation
Query!
State/province [244]
0
0
Chelyabinsk
Query!
Country [245]
0
0
Russian Federation
Query!
State/province [245]
0
0
Irkutsk
Query!
Country [246]
0
0
Russian Federation
Query!
State/province [246]
0
0
Kemerovo
Query!
Country [247]
0
0
Russian Federation
Query!
State/province [247]
0
0
Krasnoyarsk
Query!
Country [248]
0
0
Russian Federation
Query!
State/province [248]
0
0
Moscow
Query!
Country [249]
0
0
Russian Federation
Query!
State/province [249]
0
0
Novosibirsk
Query!
Country [250]
0
0
Russian Federation
Query!
State/province [250]
0
0
Omsk
Query!
Country [251]
0
0
Russian Federation
Query!
State/province [251]
0
0
Ryazan
Query!
Country [252]
0
0
Russian Federation
Query!
State/province [252]
0
0
Saratov
Query!
Country [253]
0
0
Russian Federation
Query!
State/province [253]
0
0
Sochi
Query!
Country [254]
0
0
Russian Federation
Query!
State/province [254]
0
0
St. Petersburg
Query!
Country [255]
0
0
Russian Federation
Query!
State/province [255]
0
0
Tyumen
Query!
Country [256]
0
0
Russian Federation
Query!
State/province [256]
0
0
Ufa
Query!
Country [257]
0
0
Russian Federation
Query!
State/province [257]
0
0
Yaroslavl
Query!
Country [258]
0
0
Singapore
Query!
State/province [258]
0
0
Outram Road
Query!
Country [259]
0
0
Singapore
Query!
State/province [259]
0
0
Singapore
Query!
Country [260]
0
0
South Africa
Query!
State/province [260]
0
0
Cape Town
Query!
Country [261]
0
0
South Africa
Query!
State/province [261]
0
0
Centurion
Query!
Country [262]
0
0
South Africa
Query!
State/province [262]
0
0
Johannesburg
Query!
Country [263]
0
0
South Africa
Query!
State/province [263]
0
0
Lyttleton
Query!
Country [264]
0
0
South Africa
Query!
State/province [264]
0
0
Pretoria
Query!
Country [265]
0
0
South Africa
Query!
State/province [265]
0
0
Somerset West
Query!
Country [266]
0
0
South Africa
Query!
State/province [266]
0
0
Worcester
Query!
Country [267]
0
0
Spain
Query!
State/province [267]
0
0
Barcelona
Query!
Country [268]
0
0
Spain
Query!
State/province [268]
0
0
Cabra
Query!
Country [269]
0
0
Sweden
Query!
State/province [269]
0
0
Hallingsjo
Query!
Country [270]
0
0
Sweden
Query!
State/province [270]
0
0
Kristianstad
Query!
Country [271]
0
0
Sweden
Query!
State/province [271]
0
0
Stockholm
Query!
Country [272]
0
0
Sweden
Query!
State/province [272]
0
0
Sundsvall
Query!
Country [273]
0
0
Switzerland
Query!
State/province [273]
0
0
Aarau
Query!
Country [274]
0
0
Switzerland
Query!
State/province [274]
0
0
Basel
Query!
Country [275]
0
0
Switzerland
Query!
State/province [275]
0
0
Bellinzona
Query!
Country [276]
0
0
Switzerland
Query!
State/province [276]
0
0
Chur
Query!
Country [277]
0
0
Switzerland
Query!
State/province [277]
0
0
Lausanne
Query!
Country [278]
0
0
Switzerland
Query!
State/province [278]
0
0
Luzern
Query!
Country [279]
0
0
Taiwan
Query!
State/province [279]
0
0
Hualien City
Query!
Country [280]
0
0
Taiwan
Query!
State/province [280]
0
0
Kaohsiung
Query!
Country [281]
0
0
Taiwan
Query!
State/province [281]
0
0
Taichung
Query!
Country [282]
0
0
Taiwan
Query!
State/province [282]
0
0
Taipei
Query!
Country [283]
0
0
Thailand
Query!
State/province [283]
0
0
Bangkok
Query!
Country [284]
0
0
Thailand
Query!
State/province [284]
0
0
Nakhorn Nayok
Query!
Country [285]
0
0
Turkey
Query!
State/province [285]
0
0
Ankara
Query!
Country [286]
0
0
Turkey
Query!
State/province [286]
0
0
Istanbul
Query!
Country [287]
0
0
Ukraine
Query!
State/province [287]
0
0
Chernigiv
Query!
Country [288]
0
0
Ukraine
Query!
State/province [288]
0
0
Dnipropetrovsk
Query!
Country [289]
0
0
Ukraine
Query!
State/province [289]
0
0
Donetsk
Query!
Country [290]
0
0
Ukraine
Query!
State/province [290]
0
0
Ivano-Frankivsk
Query!
Country [291]
0
0
Ukraine
Query!
State/province [291]
0
0
Kharkiv
Query!
Country [292]
0
0
Ukraine
Query!
State/province [292]
0
0
Kiev
Query!
Country [293]
0
0
Ukraine
Query!
State/province [293]
0
0
Ternopil
Query!
Country [294]
0
0
Ukraine
Query!
State/province [294]
0
0
Uzhgorod
Query!
Country [295]
0
0
Ukraine
Query!
State/province [295]
0
0
Vinnitsya
Query!
Country [296]
0
0
Ukraine
Query!
State/province [296]
0
0
Zaporizhzhia
Query!
Country [297]
0
0
United Kingdom
Query!
State/province [297]
0
0
Coventry
Query!
Country [298]
0
0
United Kingdom
Query!
State/province [298]
0
0
Hull
Query!
Country [299]
0
0
United Kingdom
Query!
State/province [299]
0
0
London
Query!
Country [300]
0
0
United Kingdom
Query!
State/province [300]
0
0
Newcastle
Query!
Country [301]
0
0
United Kingdom
Query!
State/province [301]
0
0
Plymouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Daiichi Sankyo
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00986154
Query!
Trial related presentations / publications
Vanassche T, Verhamme P, Wells PS, Segers A, Ageno W, Brekelmans MPA, Chen CZ, Cohen AT, Grosso MA, Medina AP, Mercuri MF, Winters SM, Zhang G, Weitz JI, Raskob GE, Buller HR. Impact of age, comorbidity, and polypharmacy on the efficacy and safety of edoxaban for the treatment of venous thromboembolism: An analysis of the randomized, double-blind Hokusai-VTE trial. Thromb Res. 2018 Feb;162:7-14. doi: 10.1016/j.thromres.2017.12.005. Epub 2017 Dec 13. Vandell AG, Walker J, Brown KS, Zhang G, Lin M, Grosso MA, Mercuri MF. Genetics and clinical response to warfarin and edoxaban in patients with venous thromboembolism. Heart. 2017 Nov;103(22):1800-1805. doi: 10.1136/heartjnl-2016-310901. Epub 2017 Jul 8. Brekelmans MP, Ageno W, Beenen LF, Brenner B, Buller HR, Chen CZ, Cohen AT, Grosso MA, Meyer G, Raskob G, Segers A, Vanassche T, Verhamme P, Wells PS, Zhang G, Weitz JI. Recurrent venous thromboembolism in patients with pulmonary embolism and right ventricular dysfunction: a post-hoc analysis of the Hokusai-VTE study. Lancet Haematol. 2016 Sep;3(9):e437-45. doi: 10.1016/S2352-3026(16)30080-1. Raskob GE, van Es N, Segers A, Angchaisuksiri P, Oh D, Boda Z, Lyons RM, Meijer K, Gudz I, Weitz JI, Zhang G, Lanz H, Mercuri MF, Buller HR; Hokusai-VTE investigators. Edoxaban for venous thromboembolism in patients with cancer: results from a non-inferiority subgroup analysis of the Hokusai-VTE randomised, double-blind, double-dummy trial. Lancet Haematol. 2016 Aug;3(8):e379-87. doi: 10.1016/S2352-3026(16)30057-6. Epub 2016 Jul 1. Nakamura M, Wang YQ, Wang C, Oh D, Yin WH, Kimura T, Miyazaki K, Abe K, Mercuri M, Lee LH, Segers A, Buller H. Efficacy and safety of edoxaban for treatment of venous thromboembolism: a subanalysis of East Asian patients in the Hokusai-VTE trial. J Thromb Haemost. 2015 Sep;13(9):1606-14. doi: 10.1111/jth.13055. Epub 2015 Aug 27. Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum In: N Engl J Med. 2014 Jan 23;370(4):390. Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26. doi: 10.2165/11595540-000000000-00000.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Query!
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00986154