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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ChanRx Corporation
ClinicalTrials.gov Identifier:
NCT01691313
First received: September 20, 2012
Last updated: October 29, 2013
Last verified: October 2013
  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: Multi-center, Randomized, Double-blind, Placebo-controlled Dose Modification Study to Evaluate the Safety and Efficacy of Single Oral Doses of Vanoxerine for Conversion of Subjects With Atrial Fibrillation or Flutter of Recent Onset to Normal Sinus Rhythm

Resource links provided by NLM:


Further study details as provided by ChanRx Corporation:

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


Secondary Outcome Measures:
  • subject symptom score [ Time Frame: baseline through 4 hours ] [ Designated as safety issue: No ]
    change in subject symptom score from baseline


Enrollment: 105
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
vanoxerine oral capsule
Drug: Vanoxerine
single oral dose
Other Name: GBR12909
Placebo Comparator: placebo
placebo to match vanoxerine oral capsule
Drug: Placebo
single oral dose

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 and to obtain pharmacokinetic data for vanoxerine and its metabolite following oral administration.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
ChanRx Corporation
Investigators
Study Director: Howard C Dittrich, MD ChanRx Corp.
  More Information

No publications provided

Responsible Party: ChanRx Corporation
ClinicalTrials.gov Identifier: NCT01691313     History of Changes
Other Study ID Numbers: CRX-VN-002
Study First Received: September 20, 2012
Last Updated: October 29, 2013
Health Authority: Israel: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by ChanRx Corporation:
vanoxerine
atrial fibrillation
atrial flutter
a-fib

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

ClinicalTrials.gov processed this record on October 21, 2014