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A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01181102
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: edoxaban
Drug: enoxaparin sodium

  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
DU-176b

DU-176b oral tablets, 30 mg., taken once daily for 2 weeks

edoxaban

Enoxaparin Sodium

enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks

enoxaparin sodium


Participant Flow:   Overall Study
    DU-176b   Enoxaparin Sodium
STARTED   360   356 
Safety Analysis Set   354   349 
Efficacy Analysis Population   299   295 
COMPLETED   309   310 
NOT COMPLETED   51   46 
Adverse Event                28                26 
Lack of Efficacy                3                1 
Lost to Follow-up                2                0 
Physician Decision                3                1 
Protocol Violation                5                6 
Withdrawal by Subject                10                12 



  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.
Number of baseline participants reflects the efficacy analysis population

Reporting Groups
  Description
DU-176b

DU-176b oral tablets, 30 mg., taken once daily for 2 weeks

edoxaban

Enoxaparin Sodium

enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks

enoxaparin sodium

Total Total of all reporting groups

Baseline Measures
   DU-176b   Enoxaparin Sodium   Total 
Overall Participants Analyzed 
[Units: Participants]
 299   295   594 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.6  (7.5)   72.1  (7.8)   72.4  (7.6) 
Gender 
[Units: Participants]
     
Female   245   229   474 
Male   54   66   120 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   299   295   594 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   0   0   0 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Taiwan   26   25   51 
Japan   273   270   543 


  Outcome Measures

1.  Primary:   Incidence of Subjects With Venous Thromboembolism Events.   [ Time Frame: 2 weeks ]

2.  Secondary:   Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
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  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: Kei Ibusuki, Associate Director
Organization: Daiichi Sankyo.,LTD
phone: 81-90-2732-9505
e-mail: ibusuki.kei.tx@daiichisankyo.co.jp


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

Responsible Party: Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01181102     History of Changes
Other Study ID Numbers: DU176b-B-J302
First Submitted: August 12, 2010
First Posted: August 13, 2010
Results First Submitted: January 15, 2015
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015