BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00097357

First received: November 22, 2004

Last updated: February 27, 2010

Last verified: November 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	November 22, 2004
Last Updated Date	February 27, 2010
Start Date ^ICMJE	October 2004
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 17, 2008)	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 (submitted: November 17, 2008)	Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery [ Time Frame: throughout the study ] Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery [ Time Frame: throughout the study ] Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery [ Time Frame: throughout the study ] To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule [ Time Frame: throughout the study ]
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
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Venous Thrombosis Pulmonary Embolism
Intervention ^ICMJE	Drug: Apixaban Tablets, Oral, 12 +/- 2 days Other Name: BMS-562247 Drug: Enoxaparin Injection, SQ, Q12H, 12 +/- 2 days Drug: Warfarin Tablets, Oral, QD, 12 +/- 2 days Drug: Enoxaparin Placebo Injection, SQ, BID, 12 +/- 2 days Drug: Apixaban Placebo Tablets, Oral, BID, 12 +/- 2 days
Study Arm (s)	Experimental: A1 Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo Interventions: Drug: Apixaban Drug: Enoxaparin Placebo Experimental: A2 Apixaban: 5 mg, BID PLUS Enoxaparin Placebo Interventions: Drug: Apixaban Drug: Enoxaparin Placebo Experimental: A3 Apixaban: 10 mg, BID PLUS Enoxaparin Placebo Interventions: Drug: Apixaban Drug: Enoxaparin Placebo Experimental: A4 Apixaban: 5 mg, QD PLUS Enoxaparin Placebo Interventions: Drug: Apixaban Drug: Enoxaparin Placebo Experimental: A5 Apixaban: 10 mg, QD PLUS Enoxaparin Placebo Interventions: Drug: Apixaban Drug: Enoxaparin Placebo Experimental: A6 Apixaban: 20 mg, QD PLUS Enoxaparin Placebo Interventions: Drug: Apixaban Drug: Enoxaparin Placebo Active Comparator: E1 Enoxaparin: 30 mg PLUS Apixaban Placebo Interventions: Drug: Enoxaparin Drug: Apixaban Placebo Active Comparator: W1 Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0 Intervention: Drug: Warfarin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1238
Completion Date	December 2005
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Undergoing elective unilateral total knee replacement surgery. Willing and able to undergo bilateral ascending contrast venography. Able to inject (by self or caregiver) study medication subcutaneously. Exclusion Criteria: Women of childbearing potential. Women who are pregnant or breastfeeding. Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) >=35 kg/m2
Gender	Both
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	United States, Argentina, Australia, Canada, Denmark, Israel, Mexico, Poland, Puerto Rico
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00097357
Other Study ID Numbers ^ICMJE	CV185-010
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Study Director, Bristol-Myers Squibb
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

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