Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 3 for:    hokusai
Previous Study | Return to List | Next Study

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).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00986154
First received: September 25, 2009
Last updated: March 13, 2015
Last verified: March 2015
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Venous Thromboembolism
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Thromboembolism
Venous Thrombosis
Interventions: Drug: edoxaban tosylate(DU-176b)
Drug: low molecular weight heparin/unfractionated heparin
Drug: warfarin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Heparin/Edoxaban Tosylate

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

Heparin/Warfarin

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


Participant Flow:   Overall Study
    Heparin/Edoxaban Tosylate   Heparin/Warfarin
STARTED   4143   4149 
Safety Analysis Set (Received Drug)   4118   4122 
COMPLETED   3937   3955 
NOT COMPLETED   206   194 
Death                136                127 
Lost to Follow-up                7                4 
Withdrawal by Subject                32                33 
investigator/subject decide not continue                6                3 
never received study drug                25                27 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Heparin/Edoxaban Tosylate

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

Heparin/Warfarin

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

Total Total of all reporting groups

Baseline Measures
   Heparin/Edoxaban Tosylate   Heparin/Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 4118   4122   8240 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (16.3)   55.9  (16.2)   55.8  (16.2) 
Gender 
[Units: Participants]
     
Female   1758   1766   3524 
Male   2360   2356   4716 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   866   861   1727 
Native Hawaiian or Other Pacific Islander   0   4   4 
Black or African American   156   144   300 
White   2867   2895   5762 
More than one race   0   0   0 
Unknown or Not Reported   229   218   447 
Region of Enrollment 
[Units: Participants]
     
Belarus   40   44   84 
United States   307   311   618 
Philippines   17   15   32 
Taiwan   74   64   138 
Estonia   40   36   76 
Thailand   18   24   42 
Spain   19   8   27 
Ukraine   143   148   291 
Russian Federation   260   257   517 
Israel   106   125   231 
Switzerland   27   20   47 
Italy   70   83   153 
India   245   266   511 
France   364   350   714 
Denmark   123   143   266 
Australia   90   89   179 
South Africa   185   180   365 
Netherlands   188   197   385 
China   243   241   484 
Korea, Republic of   140   130   270 
Turkey   27   24   51 
Austria   80   86   166 
United Kingdom   44   67   111 
Czech Republic   216   211   427 
Hungary   230   232   462 
Mexico   59   67   126 
Canada   109   109   218 
Argentina   26   21   47 
Poland   22   21   43 
Brazil   46   44   90 
Belgium   98   79   177 
Singapore   7   4   11 
Norway   15   15   30 
Germany   243   230   473 
Japan   106   103   209 
New Zealand   55   56   111 
Sweden   36   22   58 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE   [ Time Frame: 12 months from time of randomization ]

2.  Secondary:   The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality   [ Time Frame: 12 months from time of randomization ]

3.  Secondary:   Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment   [ Time Frame: 12 months from time of randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Lee Schwocho, Sr. Director
Organization: Daiichi Sankyo, Inc.
phone: 732-590-5000
e-mail: lschwocho@dsi.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00986154     History of Changes
Other Study ID Numbers: DU176b-D-U305
The Edoxaban Hokusai VTE Study
Study First Received: September 25, 2009
Results First Received: February 5, 2015
Last Updated: March 13, 2015
Health Authority: United States: Food and Drug Administration