NCT02454283

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

RESTORE SR: A 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 or Flutter to Normal Sinus Rhythm

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Laguna Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation or Flutter

Interventions

Type	Name	Description
DRUG	Vanoxerine HCl
DRUG	Placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-05-27
• Last updated: 2016-10-17
• Results posted: 2016-10-17

Locations

16 sites across 5 countries: United States, Bulgaria, Hungary, Israel, Russia