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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiome Pharma; Correvio International Sarl

Criteria

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