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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laguna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01691313
First received: September 20, 2012
Last updated: November 18, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Symptomatic Atrial Fibrillation
Atrial Flutter
Drug: Vanoxerine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laguna Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Conversion to Sinus Rhythm [ Time Frame: baseline through 4 hours ] [ Designated as safety issue: No ]
    proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug

  • Conversion to Sinus Rhythm [ Time Frame: baseline through 24 hours ] [ Designated as safety issue: No ]
    proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug


Enrollment: 104
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vanoxerine 200mg
vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)
Drug: Vanoxerine
single oral dose
Other Name: GBR12909
Placebo Comparator: placebo
placebo to match vanoxerine oral capsule
Drug: Placebo
single oral dose
Other Name: Placebo to match vanoxerine
Experimental: vanoxerine 300mg
vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
Drug: Vanoxerine
single oral dose
Other Name: GBR12909
Experimental: vanoxerine 400mg
vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
Drug: Vanoxerine
single oral dose
Other Name: GBR12909

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691313

Locations
Israel
Ashkelon, Israel
Haifa, Israel
Nazareth, Israel
Safed, Israel
Russian Federation
Moscow, Russian Federation
St Petersburg, Russian Federation
Sponsors and Collaborators
Laguna Pharmaceuticals, Inc.
Investigators
Study Director: Howard C Dittrich, MD ChanRx Corp.
  More Information

Publications:
Responsible Party: Laguna Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01691313     History of Changes
Other Study ID Numbers: CRX-VN-002 
Study First Received: September 20, 2012
Results First Received: October 15, 2015
Last Updated: November 18, 2015
Health Authority: Israel: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Laguna Pharmaceuticals, Inc.:
vanoxerine
atrial fibrillation
atrial flutter
a-fib

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vanoxerine
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016