A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01203072
First received: September 14, 2010
Last updated: January 15, 2015
Last verified: January 2015
Results First Received: January 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Total Knee Arthroplasty
Interventions: Drug: DU-176b
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
DU-176b 5 mg DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176b 15 mg DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176b 30 mg DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176b 60 mg DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
Placebo Placebo: Matching placebo oral tablets, once daily for 2 weeks

Participant Flow:   Overall Study
    DU-176b 5 mg     DU-176b 15 mg     DU-176b 30 mg     DU-176b 60 mg     Placebo  
STARTED     105     106     104     106     102  
COMPLETED     95     100     101     100     96  
NOT COMPLETED     10     6     3     6     6  
Adverse Event                 5                 3                 2                 4                 2  
Lack of Efficacy                 1                 0                 0                 0                 0  
Lost to Follow-up                 0                 1                 0                 0                 0  
Protocol Violation                 2                 0                 0                 0                 1  
Withdrawal by Subject                 2                 2                 1                 2                 3  



  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.
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Reporting Groups
  Description
DU-176b 5 mg DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176b 15 mg DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176b 30 mg DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176b 60 mg DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
Placebo Placebo: Matching placebo oral tablets, once daily for 2 weeks
Total Total of all reporting groups

Baseline Measures
    DU-176b 5 mg     DU-176b 15 mg     DU-176b 30 mg     DU-176b 60 mg     Placebo     Total  
Number of Participants  
[units: participants]
  88     92     88     88     89     445  
Age  
[units: years]
Mean (Standard Deviation)
  70.2  (7.7)     71.7  (7.0)     71.6  (8.1)     72.1  (7.0)     70.3  (6.5)     71.2  (7.3)  
Gender  
[units: participants]
           
Female     67     74     69     69     68     347  
Male     21     18     19     19     21     98  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native     0     0     0     0     0     0  
Asian     88     92     88     88     89     445  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0  
Black or African American     0     0     0     0     0     0  
White     0     0     0     0     0     0  
More than one race     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
           
Japan     88     92     88     88     89     445  



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


No publications provided


Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01203072     History of Changes
Other Study ID Numbers: DU176b-04
Study First Received: September 14, 2010
Results First Received: January 15, 2015
Last Updated: January 15, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency