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.
First Posted: August 3, 2010
Last Update Posted: December 15, 2015
Information provided by (Responsible Party):
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.
|Atrial Fibrillation||Drug: vernakalant hydrochloride Drug: Placebo to vernakalent hydrochloride||Phase 3|
|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:
U.S. FDA Resources
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
|Study Start Date:||August 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: vernakalant HCl
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
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
Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.
Contacts and Locations
No Contacts or Locations Provided