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

September 20, 2012
November 18, 2015
November 2012
September 2013   (final data collection date for primary outcome measure)
  • 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
Conversion to Sinus Rhythm [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
Complete list of historical versions of study NCT01691313 on ClinicalTrials.gov Archive Site
Not Provided
subject symptom score [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
change in subject symptom score from baseline
Not Provided
Not Provided
 
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Symptomatic Atrial Fibrillation
  • Atrial Flutter
  • Drug: Vanoxerine
    single oral dose
    Other Name: GBR12909
  • Drug: Placebo
    single oral dose
    Other Name: Placebo to match vanoxerine
  • Experimental: vanoxerine 200mg
    vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)
    Intervention: Drug: Vanoxerine
  • Placebo Comparator: placebo
    placebo to match vanoxerine oral capsule
    Intervention: Drug: Placebo
  • Experimental: vanoxerine 300mg
    vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
    Intervention: Drug: Vanoxerine
  • Experimental: vanoxerine 400mg
    vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
    Intervention: Drug: Vanoxerine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
October 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   Russian Federation
 
NCT01691313
CRX-VN-002
Yes
Not Provided
Not Provided
Laguna Pharmaceuticals, Inc.
Laguna Pharmaceuticals, Inc.
Not Provided
Study Director: Howard C Dittrich, MD ChanRx Corp.
Laguna Pharmaceuticals, Inc.
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP