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

NCT01174160 | Completed Phase 3 Results

• 1 other identifier: 6621-010
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

vernakalant HCl

EXPERIMENTAL

vernakalant hydrochloride

Drug: vernakalant hydrochloride

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo to vernakalent hydrochloride

Interventions

vernakalant hydrochloride 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.

Also known as: MK-6621

vernakalant HCl

Placebo to vernakalent hydrochloride 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.

Also known as: Saline

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanz Pharma: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jonathan Mather, Director, Head of Regulatory Affairs
• Organization: Cardiome Pharma

jmather@cardiome.com

+44 (0)7581148916

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2010
• First Posted: August 3, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-11