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

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.

Conditions

• Atrial Fibrillation

Interventions

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).

Sponsors & Collaborators

• Advanz Pharma

  lead INDUSTRY

Principal Investigators

• Tomas Janota, MD · VFN III. interní klinika

• Christian Torp-Pedersen, MD · Gentofte Amtssygehus - Kardiologisk afdeling

• Rein Kolk, MD · Tartu University Hospital Heart Clinic

• Etienne Aliot, MD · CHU de Nancy - Hopital Brabois, Service de Cardiologie

• Stefan Hohnloser, MD · Johann Wolfgang Goethe Universitaet Med Klinik III - Kardiologie

• Heikki Huikuri, MD · Oulu University Hospital - Dept of Internal Medicine

• Piotr Ponikowski, MD · Osrodek Chorob Serca, Klinika Kardiologii, IV Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej we Wroclawiu

• Steen Juul-Moller, MD · Universitetssjukhuset MAS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2009-10-31

Completion

2009-11-30

Countries

• Australia
• Canada
• Czechia
• Denmark
• Estonia
• Finland
• France
• Germany
• Latvia
• Lithuania
• Netherlands
• Poland
• Serbia
• Slovakia
• Sweden
• Ukraine

Study Locations