Conditions: Atrial Fibrillation or Flutter
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose arm 2: identically matching placebo capsules, orally, single-dose

Interventions: intervention 1: Vanoxerine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: