NCT00457002

Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,758 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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 within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Conditions

• Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Apixaban	Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days
DRUG	Enoxaparin	Enoxaparin: Once daily, 6-14 days Placebo: Twice daily, 30 days

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-04-05
• Last updated: 2015-12-08
• Results posted: 2014-05-20

Locations

296 sites across 35 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom