- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01691313
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
Conditions
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
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Ashkelon, Israel
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Haifa, Israel
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Nazareth, Israel
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Safed, Israel
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Moscow, Russian Federation
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St Petersburg, Russian Federation
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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)
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single oral dose
Other Names:
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Placebo Comparator: placebo
placebo to match vanoxerine oral capsule
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single oral dose
Other Names:
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Experimental: vanoxerine 300mg
vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
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single oral dose
Other Names:
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Experimental: vanoxerine 400mg
vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
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single oral dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion to Sinus Rhythm
Time Frame: baseline through 4 hours
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proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
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baseline through 4 hours
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Conversion to Sinus Rhythm
Time Frame: baseline through 24 hours
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proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
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baseline through 24 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Atrial Flutter
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Vanoxerine
Other Study ID Numbers
- CRX-VN-002
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.
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