BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

February 27, 2010 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1238

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
    • Buenos Aires
      • CAPITAL fEDERAL, Buenos Aires, Argentina
        • Local Institution
      • Prov. Buenos Aires, Buenos Aires, Argentina
        • Local Institution
    • Mendoza
      • Ciudad De Mendoza, Mendoza, Argentina
        • Local Institution
      • Godoy Cruz, Mendoza, Argentina
        • Local Institution
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Local Institution
    • Queensland
      • Chermside, Queensland, Australia
        • Local Institution
      • Gold Coast, Queensland, Australia
        • Local Institution
      • Herston, Queensland, Australia
        • Local Institution
    • South Australia
      • Bedford Park, South Australia, Australia
        • Local Institution
    • Victoria
      • 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
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Local Institution
      • Edmonton, Alberta, Canada
        • Local Institution
      • Red Deer, Alberta, Canada
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Local Institution
      • Vancouver, British Columbia, Canada
        • Local Institution
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada
        • Local Institution
    • Ontario
      • Ajax, Ontario, Canada
        • Local Institution
      • Burlington, 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
      • Sudbury, 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
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
      • Ste-foy, Quebec, Canada
        • Local Institution
      • Victoriaville, Quebec, Canada
        • Local Institution
  • Denmark
      • Frederiksberg, Denmark
        • Local Institution
      • Herlev, Denmark
        • Local Institution
      • Horsholm, Denmark
        • Local Institution
      • Silkeborg, Denmark
        • Local Institution
      • Slagelse, Denmark
        • Local Institution
  • Israel
      • Haifa, Israel
        • Local Institution
      • Holon, Israel
        • Local Institution
      • Kfar Saba, Israel
        • Local Institution
      • Petach-tikva, Israel
        • Local Institution
      • Ramat Gan, Israel
        • Local Institution
      • Rehovot, Israel
        • Local Institution
      • Tel Aviv, Israel
        • Local Institution
      • Zerifin, Israel
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico
        • Local Institution
      • Chihuahua, Mexico
        • Local Institution
      • Veracruz, Mexico
        • Local Institution
    • Baja California Sur
      • Tijuana, Baja California Sur, Mexico
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Local Institution
      • Mexico City, Distrito Federal, Mexico
        • Local Institution
    • Estado De Mexico
      • Mexico, Estado De Mexico, Mexico
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Local Institution
    • Sinaloa
      • Culiacan, Sinaloa, Mexico
        • Local Institution
    • Sonora
      • Hermosillo, Sonora, Mexico
        • Local Institution
    • Tamaulipas
      • Tampico, Tamps, Tamaulipas, Mexico
        • Local Institution
    • Veracruz
      • Jalapa, Veracruz, Mexico
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico
        • Local Institution
  • Poland
      • Bialystock, Poland
        • Local Institution
      • Gdansk, Poland
        • Local Institution
      • Lodz, Poland
        • Local Institution
      • Lublin, Poland
        • Local Institution
      • Piekary Slaskie, Poland
        • Local Institution
      • Radom, Poland
        • Local Institution
      • Sosnowiec, Poland
        • Local Institution
      • Szczecin, Poland
        • Local Institution
      • Szczecin Zdunowo, Poland
        • Local Institution
      • Warszawa, Poland
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Local Institution
      • Mobile, Alabama, United States
        • Local Institution
      • Northport, Alabama, United States
        • Local Institution
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
      • Scottsdale, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • 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
    • Colorado
      • Aurora, Colorado, United States
        • Local Institution
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Hartford, Connecticut, United States
        • Local Institution
    • Florida
      • 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
      • Ft. 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
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Cumming, Georgia, United States
        • Local Institution
      • Decatur, Georgia, United States
        • Local Institution
      • Suwanee, Georgia, United States
        • Local Institution
    • Idaho
      • Boise, Idaho, United States
        • Local Institution
      • Meridian, Idaho, United States
        • Local Institution
    • Illinois
      • Galesburg, Illinois, United States
        • Local Institution
      • Springfield, Illinois, United States
        • Local Institution
    • Kansas
      • Wichita, Kansas, United States
        • Local Institution
    • Kentucky
      • Lexington, Kentucky, United States
        • Local Institution
      • Madisonville, Kentucky, United States
        • Local Institution
    • Louisiana
      • Covington, Louisiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Massachusetts
      • Newton, Massachusetts, United States
        • Local Institution
    • Michigan
      • Port Huron, Michigan, United States
        • Local Institution
    • Mississippi
      • Jackson, Mississippi, United States
        • Local Institution
    • New York
      • Buffalo, New York, United States
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States
        • Local Institution
      • Monroe, North Carolina, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
      • Youngstown, Ohio, United States
        • Local Institution
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Local Institution
    • Pennsylvania
      • Havertown, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Texas
      • 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
    • Virginia
      • Newport News, Virginia, United States
        • Local Institution
    • Washington
      • Seattle, Washington, United States
        • Local Institution
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1

Apixaban: 2.5 mg, BID

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A2

Apixaban: 5 mg, BID

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A3

Apixaban: 10 mg, BID

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A4

Apixaban: 5 mg, QD

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A5

Apixaban: 10 mg, QD

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A6

Apixaban: 20 mg, QD

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Active Comparator: E1

Enoxaparin: 30 mg

PLUS

Apixaban Placebo
Drug: Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days
Drug: Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
Active Comparator: W1
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
Drug: Warfarin
Tablets, Oral, QD, 12 +/- 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
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
Time Frame: throughout the study
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
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
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
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 22, 2004

First Submitted That Met QC Criteria

November 22, 2004

First Posted (Estimate)

November 23, 2004

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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