BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
NCT ID: NCT00097357
Last Updated: 2010-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
1238 participants
INTERVENTIONAL
2004-10-31
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A1
Apixaban: 2.5 mg, BID
PLUS
Enoxaparin Placebo
Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
A2
Apixaban: 5 mg, BID
PLUS
Enoxaparin Placebo
Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
A3
Apixaban: 10 mg, BID
PLUS
Enoxaparin Placebo
Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
A4
Apixaban: 5 mg, QD
PLUS
Enoxaparin Placebo
Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
A5
Apixaban: 10 mg, QD
PLUS
Enoxaparin Placebo
Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
A6
Apixaban: 20 mg, QD
PLUS
Enoxaparin Placebo
Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
E1
Enoxaparin: 30 mg
PLUS
Apixaban Placebo
Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days
Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
W1
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
Warfarin
Tablets, Oral, QD, 12 +/- 2 days
Interventions
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Apixaban
Tablets, Oral, 12 +/- 2 days
Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days
Warfarin
Tablets, Oral, QD, 12 +/- 2 days
Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to undergo bilateral ascending contrast venography.
* Able to inject (by self or caregiver) study medication subcutaneously.
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Locations
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Local Institution
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Northport, Alabama, United States
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Phoenix, Arizona, United States
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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
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Fountain Valley, California, United States
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La Jolla, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Montclair, California, United States
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Oakland, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Wildomar, California, United States
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Yuba City, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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Bay Pines, Florida, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Hollywood, Florida, United States
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Melbourne, Florida, United States
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Pensacola, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Cumming, Georgia, United States
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Decatur, Georgia, United States
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Suwanee, Georgia, United States
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Boise, Idaho, United States
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Meridian, Idaho, United States
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Galesburg, Illinois, United States
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Springfield, Illinois, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Madisonville, Kentucky, United States
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Covington, Louisiana, United States
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Baltimore, Maryland, United States
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Newton, Massachusetts, United States
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Port Huron, Michigan, United States
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Jackson, Mississippi, United States
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Buffalo, New York, United States
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Charlotte, North Carolina, United States
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Monroe, North Carolina, United States
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Cincinnati, Ohio, United States
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Youngstown, Ohio, United States
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Tulsa, Oklahoma, United States
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Havertown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Newport News, Virginia, United States
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Seattle, Washington, United States
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Marshfield, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Capital fEDERAL, Buenos Aires, Argentina
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Prov. Buenos Aires, Buenos Aires, Argentina
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Godoy Cruz, Mendoza Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Camperdown, New South Wales, Australia
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Chermside, Queensland, Australia
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Gold Coast, Queensland, Australia
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Herston, Queensland, Australia
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Clayton, Victoria, Australia
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East Ringwood, Victoria, Australia
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Geelong, Victoria, Australia
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Windsor, Victoria, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Red Deer, Alberta, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Dartmouth, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Newmarket, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Oakville, Ontario, Canada
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Richmond Hill, Ontario, Canada
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St. Catharines, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Welland, Ontario, Canada
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Weston, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Ste-foy, Quebec, Canada
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Victoriaville, Quebec, Canada
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Frederiksberg, , Denmark
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Herlev, , Denmark
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Hørsholm, , Denmark
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Silkeborg, , Denmark
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Slagelse, , Denmark
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Haifa, , Israel
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Holon, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Aguascalientes, Aguascalientes, Mexico
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Tijuana, Baja California Sur, Mexico
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Chihuahua City, Chihuahua, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Culiacán, Sinaloa, Mexico
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Hermosillo, Sonora, Mexico
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México, State of Mexico, Mexico
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Tampico, Tamps, Tamaulipas, Mexico
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Jalapa, Veracruz, Mexico
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Veracruz, Veracruz, Mexico
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Mérida, Yucatán, Mexico
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Bialystock, , Poland
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Gdansk, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Piekary Śląskie, , Poland
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Radom, , Poland
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Sosnowiec, , Poland
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Szczecin, , Poland
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Szczecin Zdunowo, , Poland
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Warsaw, , Poland
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Ponce, , Puerto Rico
Countries
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Other Identifiers
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CV185-010
Identifier Type: -
Identifier Source: org_study_id
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