Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery (ADVANCE-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00452530
First received: March 23, 2007
Last updated: February 28, 2012
Last verified: February 2012

March 23, 2007
February 28, 2012
June 2007
January 2009   (final data collection date for primary outcome measure)
A combination of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]
A combination of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death after 12 days of treatment
Complete list of historical versions of study NCT00452530 on ClinicalTrials.gov Archive Site
A combination of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal PE, & VTE-related death [ Time Frame: after 12 days of treatment ] [ Designated as safety issue: No ]
A combination of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal PE, & VTE-related death after 12 days of treatment
Not Provided
Not Provided
 
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots.

The safety of apixaban will also be studied.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Drug: Enoxaparin + Placebo
    Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 12 days
    Other Name: Lovenox®
  • Drug: Apixaban + Placebo
    Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days
    Other Name: BMS-562247
  • Active Comparator: A1
    + placebo
    Intervention: Drug: Enoxaparin + Placebo
  • Experimental: A2
    + placebo
    Intervention: Drug: Apixaban + Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3054
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women
  • 18 years or older
  • scheduled for total knee replacement surgery

Exclusion Criteria:

  • hereditary or acquired bleeding disorders
  • clotting disorders
  • bleeding or high risk for bleeding
  • drugs that affect bleeding or coagulation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Brazil,   Chile,   China,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Norway,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT00452530
CV185-047, EUdraCT: 2006-006896-19
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

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