Status:
COMPLETED
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
Lead Sponsor:
Bayer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (hepar...
Detailed Description
Within the U.S., Johnson \& Johnson is sponsor.
Eligibility Criteria
Inclusion
- Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
- Written informed consent
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 DVT
- Other indication for VKA than PE/DVT
- More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
- Participation in another pharmacotherapeutic study within the prior 30 days
- Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis
- Life expectancy \< 3 months
- Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin
- Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg
- Pregnancy or childbearing potential without proper contraceptive measures
- Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
- Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT00395772
Start Date
December 1 2004
End Date
December 1 2005
Last Update
October 28 2014
Active Locations (78)
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1
Albuquerque, New Mexico, United States, 87108-4763
2
Albuquerque, New Mexico, United States, 87131
3
Chapel Hill, North Carolina, United States, 27599-7065
4
Fredericksburg, Virginia, United States, 22401