A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
vernakalant hydrochloride
Placebo to vernakalent hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
vernakalant HCl
placebo
Arm Description
vernakalant hydrochloride
placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01174160
Brief Title
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanz Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vernakalant HCl
Arm Type
Experimental
Arm Description
vernakalant hydrochloride
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
vernakalant hydrochloride
Other Intervention Name(s)
MK-6621
Intervention Description
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
Intervention Name(s)
Placebo to vernakalent hydrochloride
Other Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
Description
The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute
Time Frame
Within 90 minutes after first exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
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