NCT00989001

A Phase 3b Study of Vernakalant Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation (AF)(MK-6621-045)

A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Advanz Pharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF \> 3 hours to \<= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.

Detailed description

Participants received a 10-minute intravenous (IV) infusion of vernakalant (3 mg/kg) or an equivalent amount of normal saline (placebo), followed by a 15-minute observation period. If the participant was still in atrial fibrillation or atrial flutter, a second 10-minute IV infusion of vernakalant (2 mg/kg) or an equivalent amount of placebo was administered unless the participant experienced any dose-stopping criteria after the start of the first infusion. If a participant converted to sinus rhythm during the first or second infusion, that infusion was completed.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Vernakalant	Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes
DRUG	Placebo	Injection

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-10-02
• Last updated: 2014-03-10