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

November 18, 2015 updated by: Laguna Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ashkelon, Israel
      • Haifa, Israel
      • Nazareth, Israel
      • Safed, Israel
      • Moscow, Russian Federation
      • St Petersburg, Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vanoxerine 200mg
vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)
single oral dose
Other Names:
  • GBR12909
Placebo Comparator: placebo
placebo to match vanoxerine oral capsule
single oral dose
Other Names:
  • Placebo to match vanoxerine
Experimental: vanoxerine 300mg
vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
single oral dose
Other Names:
  • GBR12909
Experimental: vanoxerine 400mg
vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
single oral dose
Other Names:
  • GBR12909

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to Sinus Rhythm
Time Frame: baseline through 4 hours
proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
baseline through 4 hours
Conversion to Sinus Rhythm
Time Frame: baseline through 24 hours
proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
baseline through 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Howard C Dittrich, MD, ChanRx Corp.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Flutter

Clinical Trials on Placebo

3
Subscribe