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

Advanz Pharma

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: vernakalant hydrochloride

Drug: Placebo to vernakalent hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01174160

6621-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

123 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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