NCT00375609

Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)

Evaluation of the Factor Xa Inhibitor, PRT054021, Against Enoxaparin in a Randomized Trial for the Prevention of Venous Thromboembolic Events After Unilateral Total Knee Replacement (EXPERT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.

Detailed description

Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	Betrixaban	Capsule
DRUG	Enoxaparin	Administered subcutaneously

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-01-01
• Completion: 2007-02-01
• First posted: 2006-09-13
• Last updated: 2023-08-07
• Results posted: 2017-12-15

Locations

1 site across 1 country: Canada