Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Within the U.S., Johnson \& Johnson is sponsor.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Clareo Health | Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
