Phase 3
N=123
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01174160 ↗Enrolled (actual)
123
Serious AEs
10.8%
Results posted
Dec 2015
Primary outcome: Primary: Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm — 29; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- vernakalant hydrochloride (Drug); Placebo to vernakalent hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanz Pharma
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm |
29; 7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01174160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.