LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and 200 placebo subjects receive study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Unnamed facility
Littleton, Colorado, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Iowa City, Iowa, United States
Conversion to Sinus Rhythm
Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
Time frame: 24 hours
Length of Stay (From Time of Study Drug Administration)
Time frame: 8 days
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Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Plovdiv, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Budapest, Hungary
Unnamed facility
Hódmezővásárhely, Hungary
Unnamed facility
Pécs, Hungary
Unnamed facility
Rókus, Hungary
...and 6 more locations