Trial · NCT02454283
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
NCT02454283, Phase 3, Terminated, Laguna Pharmaceuticals, Inc.; results first posted 2016-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm. Trials, record NCT02454283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02454283
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
- NCT number
- NCT02454283
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Laguna Pharmaceuticals, Inc.
- Conditions
- Atrial Fibrillation or Flutter
- Interventions
- Vanoxerine HCl, Placebo
- First posted
- 2015-05-27
- Last updated
- 2016-10-17
- Results first posted
- 2016-10-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Conversion to Sinus Rhythm | 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. |
| Secondary | Length of Stay (From Time of Study Drug Administration) | 8 days |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Conversion to Sinus Rhythm | 24 hours | participants | NUMBER | |
| SECONDARY | Length of Stay (From Time of Study Drug Administration) | 8 days | days | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Conversion to Sinus Rhythm | Vanoxerine HCl | 18 | participants | ||
| Conversion to Sinus Rhythm | Placebo | 3 | participants | ||
| Length of Stay (From Time of Study Drug Administration) | Vanoxerine HCl | 4.7 | Standard Deviation 3.2 | days | |
| Length of Stay (From Time of Study Drug Administration) | Placebo | 4.2 | Standard Deviation 2.9 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vanoxerine HCl | 26 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Vanoxerine HCl | 26 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Vanoxerine HCl | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | polymorphic ventricular tachycardia | Cardiac disorders | Vanoxerine HCl | 3 | 26 | 3 |
| serious | polymorphic ventricular tachycardia | Cardiac disorders | Placebo | 0 | 15 | 0 |
| serious | torsades de pointes | Cardiac disorders | Vanoxerine HCl | 1 | 26 | 1 |
| serious | torsades de pointes | Cardiac disorders | Placebo | 0 | 15 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vanoxerine HCl | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vanoxerine HCl | 0 | 26 |
| Total, other adverse events | Placebo | 0 | 15 |
| Total, serious adverse events | Vanoxerine HCl | 4 | 26 |
| Total, serious adverse events | Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vanoxerine HCl vs Placebo: Conversion to Sinus Rhythm | Trial comparisons |
| Vanoxerine HCl vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02454283
GET https://conductscience.org/api/trials/v1/NCT02454283/registered