Overview

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Amiodarone
Dronedarone