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 Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01225822

First received: October 20, 2010

Last updated: May 23, 2012

Last verified: May 2012

History of Changes

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
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Reporting Groups

	Description
BIBR 1048 50 mg Bid	bid (twice daily) oral
BIBR 1048 150 mg Bid	bid (twice daily) oral
BIBR 1048 225 mg Bid	bid (twice daily) oral
BIBR 1048 300 mg qd	qd (once daily) oral
Enoxaparin 40 mg qd	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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Reporting Groups

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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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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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:	May 23, 2012
Health Authority:	Austria: Belgium: Czech Republic: Denmark: Finland: France: Hungary: Italy: Ethics Committee Netherlands: Norway: South Africa: Sweden:

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