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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174160
• Other study ID #: 6621-010
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2010
• Last updated: November 9, 2015
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2015
• Source: Cardiome Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardiome Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No