Status:
COMPLETED
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
Lead Sponsor:
Bayer
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embol...
Detailed Description
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor. The treatment period was followed by an observational period of 30 days starting the day after the last i...
Eligibility Criteria
Inclusion
- Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
Exclusion
- Legal lower age limitations (country specific)
- Indication for VKA other than DVT and/or PE
- Patients in whom anticoagulant treatment for their index PE or DVT should be continued
- Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate \< 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP \[Committee for Proprietary Medicinal Products\]/ICH \[International Conference on Harmonization\]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
1197 Patients enrolled
Trial Details
Trial ID
NCT00439725
Start Date
February 1 2007
End Date
September 1 2009
Last Update
November 4 2014
Active Locations (322)
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1
Little Rock, Arkansas, United States, 72205
2
Los Angeles, California, United States, 90095
3
Redlands, California, United States, 92373
4
Bay Pines, Florida, United States, 33744