Atrial Fibrillation or FlutterPhase 3RESTORE SRNCT02454283
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
A Phase 3 study testing Vanoxerine HCl in people with Atrial Fibrillation or Flutter, run by Laguna Pharmaceuticals, Inc. at 16 sites in 5 countries.
Trial summary
LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation or Flutter
- What is being tested?
- Vanoxerine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Sep 2015to Nov 2015
- Phase
- Phase 3
- 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
- Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
- Able to return for Day 8 follow up.
- Male or female 18 years of age or greater.
- Onset of AF/AFL within the 7 calendar days preceding randomization, based on symptoms.
- AF/AFL documented by ECG during the screening period.
- Adherence to local clinical standards or the ACC/AHA or ESC practice guidelines for AF/AFL regarding thromboembolic event prevention and treatment.
Who cannot join
- Previous exposure to vanoxerine HCl.
- Women of childbearing potential (neither surgically sterilized nor post-menopausal defined as cessation of menses for over one year)
- Systolic blood pressure <110 mmHg (unless documented to be usual value).
- Average heart rate <60 bpm documented by screening ECG.
- Average QTc >440 msec documented by screening ECG.
- QRS interval >140 msec documented by screening ECG.
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- Paced atrial rhythm on screening ECG.
- History of receiving another Class I or Class III antiarrhythmic drug within 3 days prior to randomization. Excluded Class I antiarrhythmic drugs include quinidine, procainamide, disopyramide, lignocaine, mexilitine, flecainide, and propafenone. Excluded Class III drugs include dofetilide, sotalol, dronedarone, and ranolazine.
- History of amiodarone (oral or IV) within the 90 days prior to randomization.
- Native or prosthetic aortic or mitral stenosis with aortic valve area ≤1.0 cm2 or mitral valve area of <1.5 cm2 or any other valvular diseases for which surgery is indicated.
- Treatment with any loop diuretic (e.g., furosemide, bumetanide, torsemide, ethacrynic acid, etc.) in the 30 days prior to randomization.
- Ejection fraction of <35% within the 3 months prior to randomization (most recent measure if more than one).
- AF/AFL as a result of surgery (postoperative AF/AFL) within 30 days prior to randomization.
- History of electrical cardioversion within the 7 calendar days prior to randomization.
- History of any polymorphic ventricular tachycardia including torsades de pointes.
- History or family history of long QT syndrome or other inherited arrhythmia syndrome.
- History of ventricular tachycardia requiring drug or device therapy.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Hungary5 sites
Study site
Budapest
Study site
Hódmezővásárhely
Study site
Pécs
Study site
Rókus
Study site
Zalaegerszeg
United States4 sites
Study site
Iowa City, Iowa
Study site
Littleton, Colorado
Study site
St Louis, Missouri
Study site
Washington D.C., District of Columbia
About this study
Official title: RESTORE SR: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Single Oral Dose of Vanoxerine for The Conversion Of Subjects With REcent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and 200 placebo subjects receive study drug.
- Conditions
- Atrial Fibrillation or Flutter
- Being tested
- Vanoxerine HCl, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vanoxerine HClDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vanoxerine HCl | Experimental | Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose Receives: Drug: Vanoxerine HCl |
| Placebo | Placebo comparator | identically matching placebo capsules, orally, single-dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to Sinus Rhythm
Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
Measured: 24 hours
Secondary outcomes (1)
Length of Stay (From Time of Study Drug Administration)
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Cardiac safety finding
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.
- Other trials for Atrial Fibrillation or FlutterStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laguna Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454283
- Sponsor's protocol ID
- LGN-VN-003
- Acronym
- RESTORE SR
- Status last verified
- Jun 2016
- First submitted
- 20 May 2015
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE SR: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Single Oral Dose of Vanoxerine for The Conversion Of Subjects With REcent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
- ClinicalTrials.gov ID
- NCT02454283
- Acronym / sponsor ID
- RESTORE SR / LGN-VN-003
- Conditions
- Atrial Fibrillation or Flutter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cardiac safety finding
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Laguna Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 17 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and 200 placebo subjects receive study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanoxerine HCl | Experimental | Drug: Vanoxerine HClVanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose |
| Placebo | Placebo comparator | Drug: Placeboidentically matching placebo capsules, orally, single-dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
- Able to return for Day 8 follow up.
- Male or female 18 years of age or greater.
- Onset of AF/AFL within the 7 calendar days preceding randomization, based on symptoms.
- AF/AFL documented by ECG during the screening period.
Key exclusion criteria (17 listed)
- Previous exposure to vanoxerine HCl.
- Women of childbearing potential (neither surgically sterilized nor post-menopausal defined as cessation of menses for over one year)
- Systolic blood pressure <110 mmHg (unless documented to be usual value).
- Average heart rate <60 bpm documented by screening ECG.
- Average QTc >440 msec documented by screening 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 |
|---|---|---|
| Vanoxerine HCl | Drug | Vanoxerine HCl |
| Placebo | Drug | Placebo |
Primary outcome
Conversion to Sinus Rhythm
Time frame: 24 hours
Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.
1 secondary outcome
Length of Stay (From Time of Study Drug Administration)
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vanoxerine HCl in people with Atrial Fibrillation or Flutter, run by Laguna Pharmaceuticals, Inc. at 16 sites in 5 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Hungary, United States, Russia, Bulgaria, Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Oct 2016). 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: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2016.