Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or flutter of recent onset to normal sinus rhythm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laguna Pharmaceuticals, Inc.
• Treatments: Vanoxerine

Criteria

Inclusion Criteria:

• provide written informed consent,

• male or female 18 years of age or greater; women of child bearing potential must use adequate contraception

• symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by symptoms

• AF/AFL documented by ECG at the start of study drug administration

Exclusion Criteria:

• Systolic blood pressure <100 mmHg.

• Average heart rate <50 bpm.

• Average QTcF (Fridericia correction) >440 ms.

• Average QRS interval >140 ms.

• Paced atrial or ventricular rhythm on ECG.

• Serum potassium <3.5 meq/L (may be corrected prior to randomization).

• Received another intravenous Class I or Class III antiarrhythmic drug within prior 3 days.

• received amiodarone (oral or IV) in prior 3 months.

• Clinical evidence or history of acute coronary syndrome within 30 days prior to randomization.

• Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.

• Rheumatic mitral stenosis with valve area of <1.5 cm2.

• Untreated hyperthyroidism.

• Acute pericarditis.

• AF/AFL as a result of surgery within the last 7 days

• History of failed electrical cardioversion

• History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).

• History or family history of long QT syndrome.

• History of ventricular tachycardia requiring drug or device therapy.

• History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart failure not related to rapid ventricular response AF.

• Ejection fraction (EF) of 35% or less.