drugset / Trial / NCT00668759

A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation

NCT00668759

Phase 3 Completed 254 enrolled Advanz Pharma
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of drug administration. The secondary objective is to compare the safety of vernakalant to amiodarone.

Timeline

Start
2008-04
Primary completion
2009-10
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amiodarone Small molecule 50 mg Intravenous
Subject Vernakalant Other / unclassified 3 mg/kg Intravenous

Indications