Symptomatic Atrial FibrillationPhase 2COR-ARTNCT01691313
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
A Phase 2 study testing Vanoxerine in people with Symptomatic Atrial Fibrillation and Atrial Flutter, run by Laguna Pharmaceuticals, Inc. at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Vanoxerine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 20Show fewer
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Israel4 sites
Study site
Ashkelon
Study site
Haifa
Study site
Nazareth
Study site
Safed
About this study
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
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.
Read the 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.
- Conditions
- Symptomatic Atrial Fibrillation, Atrial Flutter
- Being tested
- Vanoxerine, Placebo
- Keywords
- vanoxerine, atrial fibrillation, atrial flutter, a-fib
- Medical subject headings
- Atrial Flutter, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VanoxerineDrug
Also called GBR12909
single oral dose
PlaceboDrug
Also called Placebo to match vanoxerine
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| vanoxerine 200mg | Experimental | vanoxerine HCl 200mg single dose (2x 100 mg oral capsule) Receives: Drug: Vanoxerine |
| placebo | Placebo comparator | placebo to match vanoxerine oral capsule Receives: Drug: Placebo |
| vanoxerine 300mg | Experimental | vanoxerine HCl 300 mg single dose (3x 100mg oral capsules) Receives: Drug: Vanoxerine |
| vanoxerine 400mg | Experimental | vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules) Receives: Drug: Vanoxerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to Sinus Rhythm
proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
Measured: baseline through 4 hours
Conversion to Sinus Rhythm
proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
Measured: baseline through 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laguna Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard C Dittrich, MD, Study director, ChanRx Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691313
- Sponsor's protocol ID
- CRX-VN-002
- Acronym
- COR-ART
- Status last verified
- Nov 2015
- First submitted
- 20 Sep 2012
- Last updated
- 22 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25684233
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01691313
- Acronym / sponsor ID
- COR-ART / CRX-VN-002
- Conditions
- Symptomatic Atrial Fibrillation, Atrial Flutter
- Keywords
- vanoxerine, atrial fibrillation, atrial flutter, a-fib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Laguna Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 22 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vanoxerine 200mg | Experimental | Drug: Vanoxerinevanoxerine HCl 200mg single dose (2x 100 mg oral capsule) |
| placebo | Placebo comparator | Drug: Placeboplacebo to match vanoxerine oral capsule |
| vanoxerine 300mg | Experimental | Drug: Vanoxerinevanoxerine HCl 300 mg single dose (3x 100mg oral capsules) |
| vanoxerine 400mg | Experimental | Drug: Vanoxerinevanoxerine HCl 400 mg single dose (4x 100 mg oral capsules) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VanoxerineAlso: GBR12909single oral dose | Drug | vanoxerine 200mg, vanoxerine 300mg, vanoxerine 400mg |
| PlaceboAlso: Placebo to match vanoxerinesingle oral dose | Drug | placebo |
Primary outcome
Conversion to Sinus Rhythm
Time frame: baseline through 4 hours
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
proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25684233Dittrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard C Dittrich, MD study director
ChanRx Corp.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vanoxerine in people with Symptomatic Atrial Fibrillation and Atrial Flutter, run by Laguna Pharmaceuticals, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to Sinus Rhythm (time frame: baseline through 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.