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Phase 3 N=123 Randomized Double-blind Treatment

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

Atrial Fibrillation

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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