NCT00252005

Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study

Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (planned)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.

Conditions

• Deep-Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Apixaban

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-11-11
• Last updated: 2010-03-02

Locations

72 sites across 11 countries: United States, Australia, Austria, Czechia, France, Israel, Italy, Netherlands, Poland, South Africa, Sweden