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Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm (COR-ART)

Primary Purpose

Symptomatic Atrial Fibrillation, Atrial Flutter

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Vanoxerine

Placebo

About this trial

This is an interventional treatment trial for Symptomatic Atrial Fibrillation focused on measuring vanoxerine, atrial fibrillation, atrial flutter, a-fib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

vanoxerine 200mg

placebo

vanoxerine 300mg

vanoxerine 400mg

Arm Description

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

placebo to match vanoxerine oral capsule

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

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

Outcomes

Primary Outcome Measures

Conversion to Sinus Rhythm

proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug

Conversion to Sinus Rhythm

proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug

Secondary Outcome Measures

Full Information

NCT ID

NCT01691313

First Posted

September 20, 2012

Last Updated

November 18, 2015

Sponsor

Laguna Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01691313

Brief Title

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

Acronym

COR-ART

Official Title

Randomized, Double-blind, Placebo-controlled Dose Modification Study to Evaluate the Safety and Efficacy of Single Doses of Vanoxerine for Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

October 2013 (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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Atrial Fibrillation, Atrial Flutter

Keywords

vanoxerine, atrial fibrillation, atrial flutter, a-fib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vanoxerine 200mg

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo to match vanoxerine oral capsule

Arm Title

vanoxerine 300mg

Arm Type

Experimental

Arm Description

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

Arm Title

vanoxerine 400mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vanoxerine

Other Intervention Name(s)

GBR12909

Intervention Description

single oral dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo to match vanoxerine

Intervention Description

single oral dose

Primary Outcome Measure Information:

Title

Conversion to Sinus Rhythm

Description

proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug

Time Frame

baseline through 4 hours

Title

Conversion to Sinus Rhythm

Description

proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug

Time Frame

baseline through 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Howard C Dittrich, MD

Organizational Affiliation

ChanRx Corp.

Official's Role

Study Director

Facility Information:

City

Ashkelon

Country

Israel

City

Haifa

Country

Israel

City

Nazareth

Country

Israel

City

Safed

Country

Israel

City

Moscow

Country

Russian Federation

City

St Petersburg

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

25684233

Citation

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.

Results Reference

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

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