NCT00902928

A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,992 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

Conditions

• Venous Thromboembolism
• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DRUG	YM150	oral
DRUG	enoxaparin	SC injection

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2009-05-15
• Last updated: 2015-10-27

Locations

156 sites across 28 countries: United States, Australia, Austria, Bosnia and Herzegovina, Brazil, Canada, Colombia, Czechia, Denmark, Estonia, Finland, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Norway, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom