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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01174160
First Posted: August 3, 2010
Last Update Posted: December 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cardiome Pharma
  Purpose
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.

Condition Intervention Phase
Atrial Fibrillation Drug: vernakalant hydrochloride Drug: Placebo to vernakalent hydrochloride Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cardiome Pharma:

Primary Outcome Measures:
  • Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm [ Time Frame: Within 90 minutes after first exposure ]
    The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute


Enrollment: 123
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vernakalant HCl
vernakalant hydrochloride
Drug: vernakalant hydrochloride
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.
Other Name: MK-6621
Placebo Comparator: placebo
placebo
Drug: Placebo to vernakalent hydrochloride
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.
Other Name: Saline

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT01174160     History of Changes
Other Study ID Numbers: 6621-010
First Submitted: July 30, 2010
First Posted: August 3, 2010
Results First Submitted: October 9, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015
Last Verified: November 2015

Keywords provided by Cardiome Pharma:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes