Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01181141
First received: August 12, 2010
Last updated: February 3, 2015
Last verified: February 2015
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: DU-176b (edoxaban)
Drug: Enoxaparin sodium 20mg

  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
DU-176b

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

DU-176b (edoxaban)

Enoxaparin Sodium

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

Enoxaparin sodium 20mg


Participant Flow:   Overall Study
    DU-176b     Enoxaparin Sodium  
STARTED     62     30  
Safety Analysis Population     59     29  
COMPLETED     50     26  
NOT COMPLETED     12     4  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 1                 1  
Physician Decision                 2                 0  
Protocol Violation                 3                 1  
Withdrawal by Subject                 3                 1  



  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.
Number of baseline participants reflects the safety analysis population

Reporting Groups
  Description
DU-176b

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

DU-176b (edoxaban)

Enoxaparin Sodium

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

Enoxaparin sodium 20mg

Total Total of all reporting groups

Baseline Measures
    DU-176b     Enoxaparin Sodium     Total  
Number of Participants  
[units: participants]
  59     29     88  
Age  
[units: years]
Mean (Standard Deviation)
  76.5  (11.0)     75.6  (12.0)     76.3  (11.2)  
Gender  
[units: participants]
     
Female     48     22     70  
Male     11     7     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     59     29     88  
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]
     
Japan     59     29     88  



  Outcome Measures

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

2.  Secondary:   Proportion of Subjects With Venous Thromboembolism Events.   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Kenichi Sakakura, Manager
Organization: Daiichi Sankyo.,LTD
phone: 81-90-1885-0271
e-mail: sakakura.kenichi.ef@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: NCT01181141     History of Changes
Other Study ID Numbers: DU176b-B-J303
Study First Received: August 12, 2010
Results First Received: January 15, 2015
Last Updated: February 3, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency