NCT00643201

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

A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,614 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Enoxaparin	solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
DRUG	warfarin	tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
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.
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-03-26
• Last updated: 2014-04-21
• Results posted: 2014-04-10

Locations

381 sites across 31 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, South Korea, Spain, Ukraine, United Kingdom