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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Enoxaparin; Factor Xa Inhibitors; Rivaroxaban; Vitamin K; Vitamins

Criteria

Inclusion Criteria:

• Patients with acute symptomatic proximal deep vein thrombosis

Exclusion Criteria:

• Contraindication to comparator drugs

• Symptomatic Pulmonary embolism

• Conditions with increased bleeding risk

• Unstable patients with reduced life expectancy

• Severe renal impairment

• Impaired liver function

• Strong CYP 3A4 inhibitors

• Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics

• NSAIDs with half-life > 17 hours