Status:
COMPLETED
Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)
Lead Sponsor:
Bayer
Conditions:
Venous Thrombosis
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 opti...
Eligibility Criteria
Inclusion
- \- Patients with acute symptomatic proximal deep vein thrombosis
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT00839163
Start Date
March 1 2004
End Date
October 1 2005
Last Update
September 7 2023
Active Locations (110)
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1
Sydney, New South Wales, Australia, 2217
2
Adelaide, South Australia, Australia, 5011
3
Adelaide, South Australia, Australia, 5042
4
Melbourne, Victoria, Australia, 3128