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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02454283
Recruitment Status : Terminated (Cardiac safety finding)
First Posted : May 27, 2015
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
Laguna Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation or Flutter Drug: Vanoxerine HCl Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vanoxerine HCl
Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose
Drug: Vanoxerine HCl
Placebo Comparator: Placebo
identically matching placebo capsules, orally, single-dose
Drug: Placebo

Primary Outcome Measures :
  1. Conversion to Sinus Rhythm [ Time Frame: 24 hours ]
    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 :
  1. Length of Stay (From Time of Study Drug Administration) [ Time Frame: 8 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02454283

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United States, Colorado
Littleton, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Missouri
Saint Louis, Missouri, United States
Plovdiv, Bulgaria
Sofia, Bulgaria
Budapest, Hungary
Hodmezovasarhely, Hungary
Pecs, Hungary
Rokus, Hungary
Zalaegerszeg, Hungary
Ashkelon, Israel
Safed, Israel
Russian Federation
Moscow, Russian Federation
Saint Petersburg, Russian Federation
Vladimir, Russian Federation
Sponsors and Collaborators
Laguna Pharmaceuticals, Inc.
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Responsible Party: Laguna Pharmaceuticals, Inc. Identifier: NCT02454283    
Other Study ID Numbers: LGN-VN-003
First Posted: May 27, 2015    Key Record Dates
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs