Status:
COMPLETED
Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the oc...
Eligibility Criteria
Inclusion
- Men and women \>/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
Exclusion
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of PE to randomization
- Calculated creatinine clearance (CLCR) \< 30 mL/min
- Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
- Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01516814
Start Date
February 1 2012
End Date
November 1 2013
Last Update
January 23 2017
Active Locations (31)
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1
Nagoya, Aichi-ken, Japan, 457-8510
2
Toyoake, Aichi-ken, Japan, 470-1192
3
Aomori, Aomori, Japan, 030-8553
4
Chiba, Chiba, Japan, 260-8677