Venous Thrombosis Clinical Trial
Official title:
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
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 symptomatic DVT without symptomatic PE (Einstein-DVT).
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 intake of study medication, regardless of the actual duration of study drug
administration. Participants who did not complete the treatment period also entered the
observational period. It was also possible that participants did not enter the observational
period, e.g. due to withdrawal of consent or termination of study participation.
Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study
11899 (NCT00439725) did not enter the observational period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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