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NCT00097357

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00452530
CompletedInterventionalPhase 3Updated Jul 9, 2014
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT00371683
CompletedInterventionalPhase 3Updated Dec 30, 2015
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
NCT03891524
CompletedInterventionalPhase 2Updated Mar 30, 2025
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
NCT00423319
CompletedInterventionalPhase 3Updated May 14, 2014
FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty
NCT03276143
CompletedInterventionalPhase 2Updated Mar 3, 2020
Prevention of Thromboembolic Events in Total Knee Replacement Patients
NCT03393481
WithdrawnInterventionalPhase 2Updated Oct 8, 2020

BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery | NCT00097357 | Trialant

CompletedInterventionalPhase 2Phase 3Updated Mar 2, 2010

BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

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

ClinicalTrials.gov ID: NCT00097357
Lead Sponsor: Bristol-Myers SquibbINDUSTRY
Overall Status: Completed
Study Type: Interventional
Phase: Phase 2Phase 3
Enrollment: 1,238Actual
Last Update Posted: Mar 2, 2010Estimated
Start Date: Oct 2004
Primary Completion Date: Dec 2005Actual
Completion Date: Dec 2005Actual

Official Title: 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.

Venous Thrombosis
Pulmonary Embolism

Apixaban
Enoxaparin
Warfarin
Enoxaparin Placebo
Apixaban Placebo

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

No central contacts

There are no central contacts for this study.

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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

Lead Sponsor: Bristol-Myers SquibbINDUSTRY