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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
| 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 | |
More Information
| 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) |
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Atrial Fibrillation |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |