NCT00839163

Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 613 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.

Conditions

• Venous Thrombosis
• Deep Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Xarelto (Rivaroxaban, BAY59-7939)	10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
DRUG	Xarelto (Rivaroxaban, BAY59-7939)	20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
DRUG	Xarelto (Rivaroxaban, BAY59-7939)	30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
DRUG	Xarelto (Rivaroxaban, BAY59-7939)	40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
DRUG	Enoxaparin/Vitamin K-Antagonist	Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2009-02-09
• Last updated: 2023-09-07

Locations

110 sites across 19 countries: Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Peru, Poland, South Africa, Spain, Sweden, Switzerland