Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm (RESTORE SR)
Primary Purpose
Atrial Fibrillation or Flutter
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vanoxerine HCl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation or Flutter
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vanoxerine HCl
Placebo
Arm Description
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
identically matching placebo capsules, orally, single-dose
Outcomes
Primary Outcome Measures
Conversion to Sinus Rhythm
Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
Secondary Outcome Measures
Length of Stay (From Time of Study Drug Administration)
Full Information
NCT ID
NCT02454283
First Posted
May 20, 2015
Last Updated
August 23, 2016
Sponsor
Laguna Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02454283
Brief Title
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Acronym
RESTORE SR
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
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Cardiac safety finding
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laguna Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation or Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vanoxerine HCl
Arm Type
Experimental
Arm Description
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
identically matching placebo capsules, orally, single-dose
Intervention Type
Drug
Intervention Name(s)
Vanoxerine HCl
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Conversion to Sinus Rhythm
Description
Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Length of Stay (From Time of Study Drug Administration)
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Littleton
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
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
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
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