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

Not Applicable

• Conditions: -I87; I87

• Registration Number: PER-056-04
• Lead Sponsor: BAYER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients with acute symptomatic proximal deep vein thrombosis.
Men or women over 18 years of age.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Response to treatment as determined by a Complete Compression Ultra sound<br>Measure:Response to treatment as determined by a Complete Compression Ultra sound<br>Timepoints:21 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Response to treatment as determined by a complete compression ultrasound (CCUS) and a pulmonary perfusion scan<br>Measure:Response to treatment as determined by a complete compression ultrasound (CCUS) and a pulmonary perfusion scan<br>Timepoints:21 days<br>