BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00097357
First received: November 22, 2004
Last updated: February 27, 2010
Last verified: November 2008

November 22, 2004
February 27, 2010
October 2004
December 2005   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00097357 on ClinicalTrials.gov Archive Site
  • 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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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

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Venous Thrombosis
  • Pulmonary Embolism
  • Drug: Apixaban
    Tablets, Oral, 12 +/- 2 days
    Other Name: BMS-562247
  • Drug: Enoxaparin
    Injection, SQ, Q12H, 12 +/- 2 days
  • Drug: Warfarin
    Tablets, Oral, QD, 12 +/- 2 days
  • Drug: Enoxaparin Placebo
    Injection, SQ, BID, 12 +/- 2 days
  • Drug: Apixaban Placebo
    Tablets, Oral, BID, 12 +/- 2 days
  • Experimental: A1

    Apixaban: 2.5 mg, BID

    PLUS

    Enoxaparin Placebo

    Interventions:
    • Drug: Apixaban
    • Drug: Enoxaparin Placebo
  • Experimental: A2

    Apixaban: 5 mg, BID

    PLUS

    Enoxaparin Placebo

    Interventions:
    • Drug: Apixaban
    • Drug: Enoxaparin Placebo
  • Experimental: A3

    Apixaban: 10 mg, BID

    PLUS

    Enoxaparin Placebo

    Interventions:
    • Drug: Apixaban
    • Drug: Enoxaparin Placebo
  • Experimental: A4

    Apixaban: 5 mg, QD

    PLUS

    Enoxaparin Placebo

    Interventions:
    • Drug: Apixaban
    • Drug: Enoxaparin Placebo
  • Experimental: A5

    Apixaban: 10 mg, QD

    PLUS

    Enoxaparin Placebo

    Interventions:
    • Drug: Apixaban
    • Drug: Enoxaparin Placebo
  • Experimental: A6

    Apixaban: 20 mg, QD

    PLUS

    Enoxaparin Placebo

    Interventions:
    • Drug: Apixaban
    • Drug: Enoxaparin Placebo
  • Active Comparator: E1

    Enoxaparin: 30 mg

    PLUS

    Apixaban Placebo

    Interventions:
    • Drug: Enoxaparin
    • Drug: Apixaban Placebo
  • Active Comparator: W1
    Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1238
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   Denmark,   Israel,   Mexico,   Poland,   Puerto Rico
 
NCT00097357
CV185-010
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP