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A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM2)
This study is currently recruiting participants.
Verified May 2012 by Merck

First Received on July 30, 2010.   Last Updated on May 11, 2012   History of Changes
Sponsor: Merck
Information provided by (Responsible Party): Merck
ClinicalTrials.gov Identifier: NCT01174160
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Merck:

Primary Outcome Measures:
  • 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:
  • Time to conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Within 90 minutes after first exposure ] [ Designated as safety issue: No ]

Estimated Enrollment: 615
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174160

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Hong Kong
Merck Sharp & Dohme (Asia) Ltd. Recruiting
Hong Kong, Hong Kong
Contact: VACANT (cc: Michael Leung)     (852) 3971 2942        
Korea, Republic of
MSD Korea Ltd. Recruiting
Seoul, Korea, Republic of, 121-705
Contact: Yong Soo Kim     82263630241        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01174160     History of Changes
Other Study ID Numbers: 6621-010
Study First Received: July 30, 2010
Last Updated: May 11, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Merck:
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on May 23, 2012