Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00423319
First received: January 17, 2007
Last updated: March 18, 2014
Last verified: March 2014

January 17, 2007
March 18, 2014
March 2007
September 2009   (final data collection date for primary outcome measure)
A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [ Time Frame: after 35 days of treatment ] [ Designated as safety issue: No ]
A combination of asymptomatic and symptomatic DVT, non-fatal PE and all-cause death after 35 days of treatment
Complete list of historical versions of study NCT00423319 on ClinicalTrials.gov Archive Site
  • Combined endpoints: Proximal DVT, non-fatal PE, and VTE-related death [ Time Frame: after 35 days of treatment ] [ Designated as safety issue: No ]
  • Major & non-major bleeding events [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]
  • Combined endpoints after 35 days of treatment: Proximal DVT, non-fatal PE, and VTE-related death and
  • Major & non-major bleeding events
Not Provided
Not Provided
 
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery
A Phase 3 Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery

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 hip 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: Prevention
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Drug: Enoxaparin + Placebo
    Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 5 weeks
    Other Name: Lovenox®
  • Drug: Apixaban + Placebo
    Tablet + Syringes, Oral + Subcutaneous, 2.5 mg, twice daily, 5weeks
    Other Names:
    • BMS-562247
    • Lovenox®
  • 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
5407
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and non-pregnant, non breastfeeding women
  • 18 years or older
  • scheduled for hip 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
United States,   Argentina,   Australia,   Belgium,   Canada,   China,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Mexico,   Norway,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT00423319
CV185-035
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2014

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