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

NCT ID: NCT01691313

Last Updated: 2015-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-10-31

Brief 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.

Detailed Description

Vanoxerine has important antiarrhythmic properties and may prove effective in converting AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized, double-blinded, placebo-controlled, dose-modifying study in subjects who have been in symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral administration.

Conditions

Symptomatic Atrial Fibrillation; Atrial Flutter

Keywords

vanoxerine; atrial fibrillation; atrial flutter; a-fib

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vanoxerine 200mg

vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)

Group Type: EXPERIMENTAL

Vanoxerine

Intervention Type: DRUG

single oral dose

placebo

placebo to match vanoxerine oral capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single oral dose

vanoxerine 300mg

vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)

Group Type: EXPERIMENTAL

Vanoxerine

Intervention Type: DRUG

single oral dose

vanoxerine 400mg

vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)

Group Type: EXPERIMENTAL

Vanoxerine

Intervention Type: DRUG

single oral dose

Interventions

Vanoxerine

single oral dose

Intervention Type: DRUG

Placebo

single oral dose

Intervention Type: DRUG

Other Intervention Names

GBR12909; Placebo to match vanoxerine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laguna Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard C Dittrich, MD

Role: STUDY_DIRECTOR

ChanRx Corp.

Locations

Ashkelon, , Israel

Haifa, , Israel

Nazareth, , Israel

Safed, , Israel

Moscow, , Russia

Saint Petersburg, , Russia

Countries

Israel; Russia

References

Dittrich HC, Feld GK, Bahnson TD, Camm AJ, Golitsyn S, Katz A, Koontz JI, Kowey PR, Waldo AL, Brown AM. COR-ART: A multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate single oral doses of vanoxerine for conversion of recent-onset atrial fibrillation or flutter to normal sinus rhythm. Heart Rhythm. 2015 Jun;12(6):1105-12. doi: 10.1016/j.hrthm.2015.02.014. Epub 2015 Feb 12.

Reference Type: RESULT

PMID: 25684233 (View on PubMed)

Other Identifiers

CRX-VN-002

Identifier Type: -

Identifier Source: org_study_id