Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo |
|
| A2 | Experimental | Apixaban: 5 mg, BID PLUS Enoxaparin Placebo |
|
| A3 | Experimental | Apixaban: 10 mg, BID PLUS Enoxaparin Placebo |
|
| A4 | Experimental | Apixaban: 5 mg, QD PLUS Enoxaparin Placebo |
|
| A5 | Experimental | Apixaban: 10 mg, QD PLUS Enoxaparin Placebo |
|
| A6 | Experimental | Apixaban: 20 mg, QD PLUS Enoxaparin Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Tablets, Oral, 12 +/- 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Birmingham | Alabama | United States | |||
| Local Institution |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| E1 | Active Comparator | Enoxaparin: 30 mg PLUS Apixaban Placebo |
|
| W1 | Active Comparator | Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0 |
|
| Enoxaparin | Drug | Injection, SQ, Q12H, 12 +/- 2 days |
|
| Warfarin | Drug | Tablets, Oral, QD, 12 +/- 2 days |
|
| Enoxaparin Placebo | Drug | Injection, SQ, BID, 12 +/- 2 days |
|
| Apixaban Placebo | Drug | Tablets, Oral, BID, 12 +/- 2 days |
|
| 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 | throughout the study |
| To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule | throughout the study |
| Mobile |
| Alabama |
| United States |
| Local Institution | Northport | Alabama | United States |
| Local Institution | Phoenix | Arizona | United States |
| Local Institution | Scottsdale | Arizona | United States |
| Local Institution | Tucson | Arizona | United States |
| Local Institution | Little Rock | Arkansas | United States |
| Local Institution | Beverly Hills | California | United States |
| Local Institution | Encinitas | California | United States |
| Local Institution | Fountain Valley | California | United States |
| Local Institution | La Jolla | California | United States |
| Local Institution | La Mesa | California | United States |
| Local Institution | Long Beach | California | United States |
| Local Institution | Montclair | California | United States |
| Local Institution | Oakland | California | United States |
| Local Institution | Pasadena | California | United States |
| Local Institution | Sacramento | California | United States |
| Local Institution | San Bernardino | California | United States |
| Local Institution | San Diego | California | United States |
| Local Institution | Santa Monica | California | United States |
| Local Institution | Torrance | California | United States |
| Local Institution | Wildomar | California | United States |
| Local Institution | Yuba City | California | United States |
| Local Institution | Aurora | Colorado | United States |
| Local Institution | Denver | Colorado | United States |
| Local Institution | Hartford | Connecticut | United States |
| Local Institution | Bay Pines | Florida | United States |
| Local Institution | Brandon | Florida | United States |
| Local Institution | Clearwater | Florida | United States |
| Local Institution | DeLand | Florida | United States |
| Local Institution | Fort Myers | Florida | United States |
| Local Institution | Hollywood | Florida | United States |
| Local Institution | Melbourne | Florida | United States |
| Local Institution | Pensacola | Florida | United States |
| Local Institution | Sarasota | Florida | United States |
| Local Institution | St. Petersburg | Florida | United States |
| Local Institution | Tallahassee | Florida | United States |
| Local Institution | Winter Park | Florida | United States |
| Local Institution | Atlanta | Georgia | United States |
| Local Institution | Cumming | Georgia | United States |
| Local Institution | Decatur | Georgia | United States |
| Local Institution | Suwanee | Georgia | United States |
| Local Institution | Boise | Idaho | United States |
| Local Institution | Meridian | Idaho | United States |
| Local Institution | Galesburg | Illinois | United States |
| Local Institution | Springfield | Illinois | United States |
| Local Institution | Wichita | Kansas | United States |
| Local Institution | Lexington | Kentucky | United States |
| Local Institution | Madisonville | Kentucky | United States |
| Local Institution | Covington | Louisiana | United States |
| Local Institution | Baltimore | Maryland | United States |
| Local Institution | Newton | Massachusetts | United States |
| Local Institution | Port Huron | Michigan | United States |
| Local Institution | Jackson | Mississippi | United States |
| Local Institution | Buffalo | New York | United States |
| Local Institution | Charlotte | North Carolina | United States |
| Local Institution | Monroe | North Carolina | United States |
| Local Institution | Cincinnati | Ohio | United States |
| Local Institution | Youngstown | Ohio | United States |
| Local Institution | Tulsa | Oklahoma | United States |
| Local Institution | Havertown | Pennsylvania | United States |
| Local Institution | Philadelphia | Pennsylvania | United States |
| Local Institution | Pittsburgh | Pennsylvania | United States |
| Local Institution | Charleston | South Carolina | United States |
| Local Institution | Austin | Texas | United States |
| Local Institution | Dallas | Texas | United States |
| Local Institution | Houston | Texas | United States |
| Local Institution | Lubbock | Texas | United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Newport News | Virginia | United States |
| Local Institution | Seattle | Washington | United States |
| Local Institution | Marshfield | Wisconsin | United States |
| Local Institution | Buenos Aires | Buenos Aires | Argentina |
| Local Institution | Capital fEDERAL | Buenos Aires | Argentina |
| Local Institution | Prov. Buenos Aires | Buenos Aires | Argentina |
| Local Institution | Godoy Cruz | Mendoza Province | Argentina |
| Local Institution | Mendoza | Mendoza Province | Argentina |
| Local Institution | Camperdown | New South Wales | Australia |
| Local Institution | Chermside | Queensland | Australia |
| Local Institution | Gold Coast | Queensland | Australia |
| Local Institution | Herston | Queensland | Australia |
| Local Institution | Bedford Park | South Australia | Australia |
| Local Institution | Box Hill | Victoria | Australia |
| Local Institution | Clayton | Victoria | Australia |
| Local Institution | East Ringwood | Victoria | Australia |
| Local Institution | Geelong | Victoria | Australia |
| Local Institution | Windsor | Victoria | Australia |
| Local Institution | Calgary | Alberta | Canada |
| Local Institution | Edmonton | Alberta | Canada |
| Local Institution | Red Deer | Alberta | Canada |
| Local Institution | Kelowna | British Columbia | Canada |
| Local Institution | Vancouver | British Columbia | Canada |
| Local Institution | Dartmouth | Nova Scotia | Canada |
| Local Institution | Ajax | Ontario | Canada |
| Local Institution | Burlington | Ontario | Canada |
| Local Institution | Greater Sudbury | Ontario | Canada |
| Local Institution | Newmarket | Ontario | Canada |
| Local Institution | Niagara Falls | Ontario | Canada |
| Local Institution | Oakville | Ontario | Canada |
| Local Institution | Richmond Hill | Ontario | Canada |
| Local Institution | St. Catharines | Ontario | Canada |
| Local Institution | Thunder Bay | Ontario | Canada |
| Local Institution | Toronto | Ontario | Canada |
| Local Institution | Waterloo | Ontario | Canada |
| Local Institution | Welland | Ontario | Canada |
| Local Institution | Weston | Ontario | Canada |
| Local Institution | Windsor | Ontario | Canada |
| Local Institution | Montreal | Quebec | Canada |
| Local Institution | Ste-foy | Quebec | Canada |
| Local Institution | Victoriaville | Quebec | Canada |
| Local Institution | Frederiksberg | Denmark |
| Local Institution | Herlev | Denmark |
| Local Institution | Hørsholm | Denmark |
| Local Institution | Silkeborg | Denmark |
| Local Institution | Slagelse | Denmark |
| Local Institution | Haifa | Israel |
| Local Institution | Holon | Israel |
| Local Institution | Kfar Saba | Israel |
| Local Institution | Petah Tikva | Israel |
| Local Institution | Ramat Gan | Israel |
| Local Institution | Rehovot | Israel |
| Local Institution | Tel Aviv | Israel |
| Local Institution | Ẕerifin | Israel |
| Local Institution | Aguascalientes | Aguascalientes | Mexico |
| Local Institution | Tijuana | Baja California Sur | Mexico |
| Local Institution | Chihuahua City | Chihuahua | Mexico |
| Local Institution | Guadalajara | Jalisco | Mexico |
| Local Institution | Mexico City | Mexico City | Mexico |
| Local Institution | Monterrey | Nuevo León | Mexico |
| Local Institution | Culiacán | Sinaloa | Mexico |
| Local Institution | Hermosillo | Sonora | Mexico |
| Local Institution | México | State of Mexico | Mexico |
| Local Institution | Tampico, Tamps | Tamaulipas | Mexico |
| Local Institution | Jalapa | Veracruz | Mexico |
| Local Institution | Veracruz | Veracruz | Mexico |
| Local Institution | Mérida | Yucatán | Mexico |
| Local Institution | Bialystock | Poland |
| Local Institution | Gdansk | Poland |
| Local Institution | Lodz | Poland |
| Local Institution | Lublin | Poland |
| Local Institution | Piekary Śląskie | Poland |
| Local Institution | Radom | Poland |
| Local Institution | Sosnowiec | Poland |
| Local Institution | Szczecin | Poland |
| Local Institution | Szczecin Zdunowo | Poland |
| Local Institution | Warsaw | Poland |
| Local Institution | Ponce | Puerto Rico |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
| D017984 | Enoxaparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided