Clinical trial

An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of…

NCT00403767 · Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry · Completed

Key facts

NCT number NCT00403767
Title An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Official title A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
Lead sponsor Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Industry
Collaborators Bayer Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Atrial Fibrillation, Stroke, Embolism
Intervention type Drug
Interventions Rivaroxaban, Warfarin, Matching placebo for Rivaroxaban arm (Warfarin placebo), Matching placebo for Warfarin arm (Rivaroxaban placebo)
Enrollment 14,269
Start date Dec 1, 2006
Primary completion Sep 1, 2010
Completion Sep 1, 2010
First posted Nov 27, 2006
Last update posted Apr 29, 2014
Countries Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark and 32 more

At a glance

  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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