NCT01627106

A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)

A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Advanz Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Vernakalant	Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered.
DRUG	Amiodarone	Administered IV as per product label

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2012-06-25
• Last updated: 2013-08-26