drugset / Trial / NCT00668759
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amiodarone | Small molecule | 50 mg | Intravenous |
| Subject | Vernakalant | Other / unclassified | 3 mg/kg | Intravenous |