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

NCT ID: NCT01174160

Last Updated: 2015-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-10-31

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

vernakalant HCl

vernakalant hydrochloride

Group Type: EXPERIMENTAL

vernakalant hydrochloride

Intervention Type: DRUG

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.

placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo to vernakalent hydrochloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MK-6621; Saline

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanz Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

Hong Kong; India; South Korea; Taiwan

Other Identifiers

6621-010

Identifier Type: -

Identifier Source: org_study_id