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


Tracking Information

Start Date  ICMJEMay 2008
Estimated Primary Completion DateMay 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 5, 2008)		Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ]
Change HistoryComplete list of historical versions of study NCT00633893 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 5, 2008)		Bleeding [ Time Frame: upon occurrence during study treatment ]

Descriptive Information

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

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEVenous Thrombosis
Intervention  ICMJE
  • Drug: Apixaban
    Tablets, Oral, twice daily, 12 months
    Other Name: BMS-562247
  • Drug: Placebo
    Tablets, Oral, twice daily, 12 months
Study Arms / Comparison Groups
  • 1: Experimental
    2.5 mg
    Intervention: Drug: Apixaban
  • 2: Experimental
    5.0 mg
    Intervention: Drug: Apixaban
  • 3: Active Comparator
    0 mg
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE2430
Estimated Completion DateApril 2013
Estimated Primary Completion DateMay 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;
  • Anticoagulant treatment completed
  • No recurrence of VTE

Exclusion Criteria:

  • Subjects with indications for long-term treatment with a vitamin K antagonist
  • Active bleeding or high risk for serious bleeding
  • Short life expectancy
  • Uncontrolled high blood pressure
  • 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,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Norway,   Philippines,   Poland,   Portugal,   Puerto Rico,   Romania,  Russian Federation,   Singapore,   South Africa,   Spain,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00633893
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECV185-057, EUDRACT: 2007-004953-27
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJEPfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb