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A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Phase 3
40 Years
Not Enrolling
Venous Thrombosis, Pulmonary Embolism

Thank you

Trial Information

A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.

Inclusion Criteria:

- men and non-pregnant, non-breastfeeding women

- 40 years or older

- hospitalized with congestive heart failure or acute respiratory failure

- infection (without septic shock)

- acute rheumatic disorder

- inflammatory bowel disease

Exclusion Criteria:

- patients with VTE

- active bleeding or at high risk of bleeding

- unable to take oral medication

- with diseases requiring ongoing treatment with anticoagulants or antiplatelets other
than aspirin at a dose ≤ 165 mg/day.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Composite of venous thromboembolism (VTE) and VTE-related death

Outcome Time Frame:

during 30 days of double-blind treatment

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

May 2011

Related Keywords:

  • Venous Thrombosis
  • Pulmonary Embolism
  • Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients
  • Embolism
  • Pulmonary Embolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism



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