Status:
COMPLETED
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Lead Sponsor:
Advanz Pharma
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 c...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01174160
Start Date
August 1 2010
End Date
October 1 2012
Last Update
December 15 2015
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