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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,238
Tablets, Oral, 12 +/- 2 days
Injection, SQ, Q12H, 12 +/- 2 days
Tablets, Oral, QD, 12 +/- 2 days
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
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
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Injection, SQ, BID, 12 +/- 2 days
Tablets, Oral, BID, 12 +/- 2 days
Local Institution
Birmingham, Alabama, United States
Local Institution
Mobile, Alabama, United States
Local Institution
Northport, Alabama, United States
Local Institution
Phoenix, Arizona, United States
Local Institution
Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Encinitas, California, United States
Local Institution
Fountain Valley, California, United States
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