A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo to vernakalent hydrochloride; Drug: vernakalant hydrochloride

• Registration Number: NCT01174160
• Lead Sponsor: Advanz Pharma

Brief Summary

This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.

Detailed Description

Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Study Timeline

• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-07-30
• Study Start: 2010-08
• Study First Posted: 2010-08-03
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Results First Submitted: 2015-10-09
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-09
• Last Update Submitted: 2015-11-09
• Results First Posted: 2015-12-15
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Abstinent or willing to use 2 acceptable methods of birth control
• Patient has an atrial arrhythmia with dysrhythmic symptoms
• Patient is receiving adequate anticoagulant therapy
• Patient has stable blood pressure
• Patient weighs between 45 and 136 kg (99 and 300 lbs)
• Patient is adequately hydrated

Exclusion Criteria

• Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
• Patient routinely consumes more than 2 alcoholic drinks per day
• Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
• Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
• Patient has severe aortic stenosis
• Patient has atrial flutter
• Patient has Class IV congestive heart failure (CHF)
• Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS)
• Patient has had cardiac surgery within 30 days
• Patient has known atrial thrombus
• Patient has reversible causes of Atrial Fibrillation
• Patient has failed electrical cardioversion during current episode of Atrial Fibrillation
• Patient has uncorrected electrolyte imbalance
• Patient has clinical evidence of digoxin toxicity
• Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days
• Patient is known to be HIV positive
• Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo to vernakalent hydrochloride	placebo
vernakalant HCl	vernakalant hydrochloride	vernakalant hydrochloride

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm	Within 90 minutes after first exposure	The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute