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

A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: vernakalant hydrochloride; Drug: Placebo to vernakalent hydrochloride

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo to vernakalent hydrochloride; Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.; Other Names: Saline
Experimental: vernakalant HCl; vernakalant hydrochloride	Drug: vernakalant hydrochloride; Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.; Other Names: MK-6621

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Advanz Pharma

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: July 30, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 6621-010