Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism


Tracking Information

Start Date  ICMJEAugust 2008
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2008)		Venous thromboembolic recurrence or death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJE 
 (submitted: March 20, 2008)		Venous thromboembolic recurrence or death [ Time Frame: upon occurrence during study treatment ]
Change HistoryComplete list of historical versions of study NCT00643201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 25, 2008)		Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: March 20, 2008)		Bleeding [ Time Frame: upon occurrence during study treatment ]

Descriptive Information

Brief Title  ICMJEEfficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Official Title  ICMJEA Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEVenous Thrombosis
Intervention  ICMJE
  • Drug: Enoxaparin
    solution, subcutaneous, 1 mg/kg Q12h until INR ≥2, twice daily
  • Drug: warfarin
    tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
    Other Names:
    • Coumadin
    • BMS-565793
  • Drug: Placebo for apixaban
    tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
  • Drug: Placebo for enoxaparin
    solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2, twice daily
  • Drug: Placebo for warfarin
    tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
  • Drug: apixaban
    tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
    Other Name: BMS-562247
Study Arms / Comparison Groups
  • 1: Active Comparator
    Interventions:
    • Drug: Enoxaparin
    • Drug: warfarin
    • Drug: Placebo for apixaban
  • 2: Experimental
    Interventions:
    • Drug: Placebo for enoxaparin
    • Drug: Placebo for warfarin
    • Drug: apixaban

Recruitment Information

Estimated Enrollment  ICMJE4816
Estimated Completion DateDecember 2012
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women ≥ 18 years of age
  • Clinical diagnosis of DVT or PE

Exclusion Criteria:

  • Contraindications for enoxaparin or warfarin
  • Active bleeding or high risk for serious bleeding
  • Short life expectancy
  • Uncontrolled high blood pressure
  • Significantly impaired kidney or liver function
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Norway,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   South 

Administrative Information

NCT ID  ICMJENCT00643201
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECV185-056, EUDRACT: 2007-007867-25
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJEPfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb


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