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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00633893
First received: March 5, 2008
Last updated: November 6, 2012
Last verified: November 2012
History of Changes

March 5, 2008
November 6, 2012
May 2008
September 2012   (final data collection date for primary outcome measure)
Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]
Venous Thromboembolic Recurrence or Death [ Time Frame: upon occurrence during study treatment ]
Complete list of historical versions of study NCT00633893 on ClinicalTrials.gov Archive Site
Bleeding [ Time Frame: upon occurrence during study treatment ] [ Designated as safety issue: Yes ]
Bleeding [ Time Frame: upon occurrence during study treatment ]
Not Provided
Not Provided
 
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

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)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Venous Thrombosis
  • Drug: Apixaban
    Tablets, Oral, twice daily, 12 months
    Other Name: BMS-562247
  • Drug: Placebo
    Tablets, Oral, twice daily, 12 months
  • Experimental: 1
    2.5 mg
    Intervention: Drug: Apixaban
  • Experimental: 2
    5.0 mg
    Intervention: Drug: Apixaban
  • Active Comparator: 3
    0 mg
    Intervention: Drug: Placebo
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; PLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United 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,   Ukraine,   United Kingdom
 
NCT00633893
CV185-057, EUDRACT: 2007-004953-27
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Pfizer
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2012

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