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  
Number of Participants  
[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


No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:

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