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:
Information provided by (Responsible Party):
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT01174160
First received: July 30, 2010
Last updated: August 23, 2013
Last verified: August 2013
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to conversion of Atrial Fibrillation to sinus rhythm [ Time Frame: Up to 24 hours after first exposure ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Cardiome Pharma
ClinicalTrials.gov Identifier: NCT01174160     History of Changes
Other Study ID Numbers: 6621-010
Study First Received: July 30, 2010
Last Updated: August 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Cardiome Pharma:
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on July 31, 2014