BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01225822
First received: October 20, 2010
Last updated: February 18, 2014
Last verified: February 2014
Results First Received: November 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: Enoxaparin
Drug: BIBR 1048

  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
There were 1973 patients enrolled/randomised in this trial but only 1949 started treatment

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
BIBR 1048 50 mg Bid Dabigatran 50 mg bid(twice daily) oral
BIBR 1048 150 mg Bid Dabigatran 150 mg bid(twice daily) oral
BIBR 1048 225 mg Bid Dabigatran 225 mg bid(twice daily) oral
BIBR 1048 300 mg qd Dabigatran 300 mg qd(once daily) oral
Enoxaparin 40 mg qd Enoxaparin 40 qd (once daily) subcutaneous injection

Participant Flow:   Overall Study
    BIBR 1048 50 mg Bid     BIBR 1048 150 mg Bid     BIBR 1048 225 mg Bid     BIBR 1048 300 mg qd     Enoxaparin 40 mg qd  
STARTED     389     390     393     385     392  
COMPLETED     351     334     355     333     361  
NOT COMPLETED     38     56     38     52     31  
Adverse Event                 13                 31                 18                 23                 14  
Protocol Violation                 6                 8                 6                 7                 4  
Lost to Follow-up                 0                 0                 0                 1                 0  
Withdrawal by Subject                 6                 7                 7                 11                 6  
Not Specified                 13                 10                 7                 10                 7  



  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
BIBR 1048 50 mg Bid Dabigatran 50 mg bid (twice daily) oral
BIBR 1048 150 mg Bid Dabigatran 150 mg bid (twice daily) oral
BIBR 1048 225 mg Bid Dabigatran 225 mg bid (twice daily) oral
BIBR 1048 300 mg qd Dabigatran 300 mg qd (once daily) oral
Enoxaparin 40 mg qd Enoxaparin 40 mg qd (once daily) subcutaneous injection
Total Total of all reporting groups

Baseline Measures
    BIBR 1048 50 mg Bid     BIBR 1048 150 mg Bid     BIBR 1048 225 mg Bid     BIBR 1048 300 mg qd     Enoxaparin 40 mg qd     Total  
Number of Participants  
[units: participants]
  389     390     393     385     392     1949  
Age, Customized [1]
[units: years]
Mean ± Standard Deviation
  66.07  ± 10.23     65.86  ± 10.77     65.87  ± 10.63     66.47  ± 10.37     65.03  ± 11.03     65.86  ± 10.61  
Gender [1]
[units: participants]
           
Female     223     252     229     246     241     1191  
Male     166     138     164     139     151     758  
[1] Safety set population



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Venous Thromboembolic (VTE) Events   [ Time Frame: Treatment period (up to day 8+/-2 days visit) ]

2.  Primary:   Number of Participants With Major Bleeding Events (MBE)   [ Time Frame: From approximately 14 days prior to surgery to 4-6 weeks post surgery ]

3.  Secondary:   Number of Participants With VTE Events and All Cause Mortality   [ Time Frame: Treatment period (up to day 8+/-2 days visit) ]

4.  Secondary:   Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality   [ Time Frame: Treatment period (up to day 10) ]

5.  Secondary:   Number of Participants With Proximal DVT   [ Time Frame: Treatment period (up to day 8+/-2 days visit) ]

6.  Secondary:   Volume of Blood Loss   [ Time Frame: Day 1 (Day of surgery) ]

7.  Secondary:   Rate of Transfusions Due to Bleedings   [ Time Frame: Day 1 (Day of surgery) ]

8.  Secondary:   Number of Participants With Clinically Significant, Minor or Any Bleeding Events   [ Time Frame: Treatment period (up to day 8+/-2 days visit) ]

9.  Secondary:   Laboratory Analyses   [ Time Frame: Screening to end of treatment ]

10.  Secondary:   Plasma Concentration (Cmax) of Dabigatran   [ Time Frame: Day 1 to end of treatment ]

11.  Secondary:   Area Under the Plasma Concentration-time Curve During a Dosing Interval   [ Time Frame: up to day 8+/-2 days visit ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01225822     History of Changes
Other Study ID Numbers: 1160.19
Study First Received: October 20, 2010
Results First Received: November 18, 2010
Last Updated: February 18, 2014
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