drugset / Trial / NCT02454283

Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm

NCT02454283 ↗

Phase 3 Terminated 41 enrolled Laguna Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-09
Primary completion
2015-11
Completion
2015-11

Outcome

Outcome not reported

Stopped: “Cardiac safety finding”

Drugs

EvaluationDrugModalityDoseRoute
Subject vanoxerine Small molecule 400 mg Oral

Indications