Status:
COMPLETED
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
Lead Sponsor:
Bayer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Venous Thrombosis
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a ...
Detailed Description
The following laboratory variables were determined at baseline at the local laboratories: Hemoglobin, platelets, activated partial thromboplastin time (aPTT), international normalized ratio (INR), ala...
Eligibility Criteria
Inclusion
- Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism
- Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin)
Exclusion
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep -vein thrombosis and/or pulmonary embolism
- Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or pulmonary embolism
- Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
- Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00786422
Start Date
May 1 2009
End Date
June 1 2011
Last Update
November 18 2015
Active Locations (16)
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1
Redcliffe, Queensland, Australia, 4020
2
Vienna, Vienna, Austria, 1090
3
São Paulo, São Paulo, Brazil, 01323-001
4
München, Bavaria, Germany, 80331