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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01174160
First received: July 30, 2010
Last updated: May 28, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
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: 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
No Contacts or Locations Provided
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 28, 2013 |
| 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 June 18, 2013