Clinical trial NCT02454283: Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation or Flutter
Lead sponsor: Laguna Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Conversion to Sinus Rhythm
timeFrame: 24 hours
Secondary outcomes:
measure: Length of Stay (From Time of Study Drug Administration)
timeFrame: 8 days
Other outcomes:
Locations:
city: Littleton
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Iowa City
country: United States
state: Iowa
city: Saint Louis
country: United States
state: Missouri
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Budapest
country: Hungary
city: Hodmezovasarhely
country: Hungary
city: Pecs
country: Hungary
city: Rokus
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Ashkelon
country: Israel
city: Safed
country: Israel
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Vladimir
country: Russian Federation
Study officials:
References: