BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00097357 |
Recruitment Status
:
Completed
First Posted
: November 23, 2004
Last Update Posted
: March 2, 2010
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Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
Tracking Information | |||
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First Submitted Date ICMJE | November 22, 2004 | ||
First Posted Date ICMJE | November 23, 2004 | ||
Last Update Posted Date | March 2, 2010 | ||
Study Start Date ICMJE | October 2004 | ||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery [ Time Frame: throughout the study ] | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00097357 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery | ||
Official Title ICMJE | A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery | ||
Brief Summary | The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
1238 | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date | December 2005 | ||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Argentina, Australia, Canada, Denmark, Israel, Mexico, Poland, Puerto Rico, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00097357 | ||
Other Study ID Numbers ICMJE | CV185-010 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Study Director, Bristol-Myers Squibb | ||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Bristol-Myers Squibb | ||
Verification Date | November 2008 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |