Status:
COMPLETED
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Lead Sponsor:
Bayer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute ...
Detailed Description
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.
Eligibility Criteria
Inclusion
- Confirmed acute symptomatic proximal PE with or without symptomatic DVT
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 and/or PE
- Other indication for VKA than DVT and/or PE
- The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
4833 Patients enrolled
Trial Details
Trial ID
NCT00439777
Start Date
March 1 2007
End Date
December 1 2011
Last Update
February 27 2014
Active Locations (305)
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1
Little Rock, Arkansas, United States, 72205
2
Redlands, California, United States, 92373
3
Bay Pines, Florida, United States, 33744
4
Miami, Florida, United States, 33136-1096