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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

September 20, 2012
October 29, 2013
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: 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
subject symptom score [ Time Frame: baseline through 4 hours ] [ Designated as safety issue: No ]
change in subject symptom score from baseline
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 Single Oral Doses of Vanoxerine for Conversion of Atrial Fibrillation or Flutter of Recent Onset to Normal Sinus Rhythm
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

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 and to obtain pharmacokinetic data for vanoxerine and its metabolite 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
  • Experimental: vanoxerine
    vanoxerine oral capsule
    Intervention: Drug: Vanoxerine
  • Placebo Comparator: placebo
    placebo to match vanoxerine oral capsule
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
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
ChanRx Corporation
ChanRx Corporation
Not Provided
Study Director: Howard C Dittrich, MD ChanRx Corp.
ChanRx Corporation
October 2013

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