A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010)
- Conditions
- Health Condition 1: null- Atrial FibrillationHealth Condition 2: I489- Unspecified atrial fibrillation and atrial flutterHealth Condition 3: I489- Unspecified atrial fibrillation and atrial flutter
- Registration Number
- CTRI/2012/07/002823
- Lead Sponsor
- Merck Sharp and Dohme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 615
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.
- 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
-Ejection Fraction 35%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: No ]Timepoint: Proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method Time to conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: No ]Timepoint: Within 90 minutes after first exposure