NCT00839826

ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 641 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

Conditions

• Thromboembolism
• Prevention

Interventions

Type	Name	Description
DRUG	Rivaroxaban (BAY59-7939)	2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial
DRUG	Enoxaparin	40 mg bid

Timeline

• Start date: 2002-12-01
• Primary completion: 2003-11-01
• Completion: 2003-11-01
• First posted: 2009-02-10
• Last updated: 2014-12-17

Locations

41 sites across 11 countries: Austria, Belgium, Denmark, France, Germany, Israel, Netherlands, Norway, Poland, Sweden, United Kingdom