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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation or Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vanoxerine HCl

Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose

Group Type EXPERIMENTAL

Vanoxerine HCl

Intervention Type DRUG

Placebo

identically matching placebo capsules, orally, single-dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vanoxerine HCl

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
* Able to return for Day 8 follow up.
* Male or female 18 years of age or greater.
* Onset of AF/AFL within the 7 calendar days preceding randomization, based on symptoms.
* AF/AFL documented by ECG during the screening period.
* Adherence to local clinical standards or the ACC/AHA or ESC practice guidelines for AF/AFL regarding thromboembolic event prevention and treatment.

Exclusion Criteria

* Previous exposure to vanoxerine HCl.
* Women of childbearing potential (neither surgically sterilized nor post-menopausal defined as cessation of menses for over one year)
* Systolic blood pressure \<110 mmHg (unless documented to be usual value).
* Average heart rate \<60 bpm documented by screening ECG.
* Average QTc \>440 msec documented by screening ECG.
* QRS interval \>140 msec documented by screening ECG.
* Paced atrial rhythm on screening ECG.
* History of receiving another Class I or Class III antiarrhythmic drug within 3 days prior to randomization. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexilitine, flecainide, and propafenone. Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.
* History of amiodarone (oral or IV) within the 90 days prior to randomization.
* Native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2 or mitral valve area of \<1.5 cm2 or any other valvular diseases for which surgery is indicated.
* Treatment with any loop diuretic (e.g., furosemide, bumetanide, torsemide, ethacrynic acid, etc.) in the 30 days prior to randomization.
* Ejection fraction of \<35% within the 3 months prior to randomization (most recent measure if more than one).
* AF/AFL as a result of surgery (postoperative AF/AFL) within 30 days prior to randomization.
* History of electrical cardioversion within the 7 calendar days prior to randomization.
* History of any polymorphic ventricular tachycardia including torsades de pointes.
* History or family history of long QT syndrome or other inherited arrhythmia syndrome.
* History of ventricular tachycardia requiring drug or device therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No