search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
vernakalant hydrochloride
Placebo to vernakalent hydrochloride
Sponsored by
Advanz Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    vernakalant HCl

    placebo

    Arm Description

    vernakalant hydrochloride

    placebo

    Outcomes

    Primary Outcome Measures

    Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
    The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2010
    Last Updated
    November 9, 2015
    Sponsor
    Advanz Pharma
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01174160
    Brief Title
    A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    September 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Advanz Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    123 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vernakalant HCl
    Arm Type
    Experimental
    Arm Description
    vernakalant hydrochloride
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    vernakalant hydrochloride
    Other Intervention Name(s)
    MK-6621
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to vernakalent hydrochloride
    Other Intervention Name(s)
    Saline
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
    Description
    The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute
    Time Frame
    Within 90 minutes after first exposure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs