Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-29 @ 12:50 AM
Study NCT ID:
NCT01174160
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2010-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
Sponsor:
Advanz Pharma
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: