NCT00668759

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

A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Advanz Pharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in subjects with symptomatic AF of 3 to 48 hours duration. Subjects will be randomized to receive vernakalant injection or amiodarone injection in a 1:1 ratio. Safety will be assessed through the monitoring of adverse events, vital signs, continuous telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests. At 2 hours after the start of infusion, electrical cardioversion may be performed or rate control medication may be administered. Class I and Class III antiarrhythmics are not to be administered for 24 hours after the start of infusion. Subjects are to remain in the clinic for at least 6 hours after the start of infusion. Subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a follow-up telephone call at 30 (±3) days for assessment of serious adverse events, concomitant medications related to serious adverse events, and recurrence of AF. All roles were blinded with the exception of each site's designated unblinded personnel who were responsible for randomization and preparation, dispensation and accountability of the study medication. Expanded Access was not available through this protocol.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Vernakalant Injection	10-minute infusion of 3 mg/kg vernakalant injection followed by a 15-minute observation period, followed by an additional 10-minute infusion of 2 mg/kg of vernakalant if required (if the subject is still in AF).
DRUG	Amiodarone Injection:	60-minute infusion of 5 mg/kg amiodarone followed by a maintenance infusion of 50 mg amiodarone over an additional 60 minutes (equivalent to approximately 15 mg/kg over 24 hrs).

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2008-04-29
• Last updated: 2009-12-15

Locations

100 sites across 16 countries: Australia, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Latvia, Lithuania, Netherlands, Poland, Serbia, Slovakia, Sweden, Ukraine