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A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (eTRIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT01662908
First received: August 2, 2012
Last updated: May 11, 2017
Last verified: May 2017
Results First Received: September 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Deep Vein Thrombosis
Venous Thrombosis
Interventions: Drug: edoxaban tosylate
Drug: enoxaparin/unfractionated heparin
Drug: warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From September 2012 through January 2014, a total of 85 patients were enrolled at 26 centers in North America (US and Canada). One subject was not included in either the full analysis set or the safety analysis set because of major protocol violation - he did not take any dose of study drug.

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
Edoxaban Participants treated with edoxaban
Warfarin Participants treated with warfarin

Participant Flow:   Overall Study
    Edoxaban   Warfarin
STARTED   56   28 
COMPLETED   50   23 
NOT COMPLETED   6   5 



  Baseline Characteristics
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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
Edoxaban Participants treated with edoxaban
Warfarin Participants treated with warfarin
Total Total of all reporting groups

Baseline Measures
   Edoxaban   Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   28   84 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      41  73.2%      22  78.6%      63  75.0% 
>=65 years      15  26.8%      6  21.4%      21  25.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  26.8%      7  25.0%      22  26.2% 
Male      41  73.2%      21  75.0%      62  73.8% 
Region of Enrollment 
[Units: Participants]
     
Canada   16   6   22 
United States   40   22   62 


  Outcome Measures
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1.  Primary:   Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]   [ Time Frame: Baseline to final visit (Day 14-21) ]

2.  Secondary:   Number of Participants With Clinically Relevant Bleeding   [ Time Frame: Initial dose of study drug up to 3 days after last dose ]

3.  Secondary:   Number of Participants With Recurrence of Venous Thromboembolism (VTE)   [ Time Frame: Baseline to final visit (Day 14-21) ]

4.  Secondary:   Number of Participants With Major Adverse Cardiovascular Events (MACE)   [ Time Frame: Initial dose of study drug up to 3 days after last dose ]

5.  Secondary:   Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel   [ Time Frame: Baseline to final visit (Day 14-21) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Senior Director, CVM TA Development
Organization: Daiichi Sankyo, Inc.
phone: 732-590-5000


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

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01662908     History of Changes
Other Study ID Numbers: DU176b-D-U211
Study First Received: August 2, 2012
Results First Received: September 28, 2016
Last Updated: May 11, 2017