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Trial · NCT01691313

Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm

NCT01691313, Phase 2, Completed, Laguna Pharmaceuticals, Inc.; results first posted 2015-12-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm. Trials, record NCT01691313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01691313

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm
NCT number
NCT01691313
Status
Completed
Phases
Phase 2
Enrollment
104 participants, actual
Lead sponsor
Laguna Pharmaceuticals, Inc.
Conditions
Symptomatic Atrial Fibrillation, Atrial Flutter
Interventions
Vanoxerine, Placebo
First posted
2012-09-24
Last updated
2015-12-22
Results first posted
2015-12-22

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryConversion to Sinus Rhythmbaseline through 4 hoursproportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
PrimaryConversion to Sinus Rhythmbaseline through 24 hoursproportion of subjects who convert to sinus rhythm through 24 hours after start of study drug

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYConversion to Sinus Rhythmbaseline through 4 hoursparticipantsNUMBER
PRIMARYConversion to Sinus Rhythmbaseline through 24 hoursparticipantsNUMBER

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Conversion to Sinus RhythmPlacebo4participants
Conversion to Sinus RhythmVanoxerine 200mg4participants
Conversion to Sinus RhythmVanoxerine 300mg11participants
Conversion to Sinus RhythmVanoxerine 400mg13participants
Conversion to Sinus RhythmPlacebo10participants
Conversion to Sinus RhythmVanoxerine 200mg13participants
Conversion to Sinus RhythmVanoxerine 300mg16participants
Conversion to Sinus RhythmVanoxerine 400mg21participants

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDVanoxerine 200mg22
Overall StudySTARTEDPlacebo32
Overall StudySTARTEDVanoxerine 300mg25
Overall StudySTARTEDVanoxerine 400mg25
Overall StudyCOMPLETEDVanoxerine 200mg22
Overall StudyCOMPLETEDPlacebo32
Overall StudyCOMPLETEDVanoxerine 300mg25
Overall StudyCOMPLETEDVanoxerine 400mg25
Overall StudyNOT COMPLETEDVanoxerine 200mg0
Overall StudyNOT COMPLETEDPlacebo0

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherSinus bradycardiaCardiac disordersPlacebo0320
otherSinus bradycardiaCardiac disordersVanoxerine 200mg0220
otherSinus bradycardiaCardiac disordersVanoxerine 300mg1251
otherSinus bradycardiaCardiac disordersVanoxerine 400mg2252
otherSupraventricular extrasystolesCardiac disordersPlacebo0320
otherSupraventricular extrasystolesCardiac disordersVanoxerine 200mg0220
otherSupraventricular extrasystolesCardiac disordersVanoxerine 300mg1251
otherSupraventricular extrasystolesCardiac disordersVanoxerine 400mg2252
otherVentricular extrasystolesCardiac disordersPlacebo1321
otherVentricular extrasystolesCardiac disordersVanoxerine 200mg0220

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo
Total, all-cause mortalityVanoxerine 200mg
Total, all-cause mortalityVanoxerine 300mg
Total, all-cause mortalityVanoxerine 400mg
Total, other adverse eventsPlacebo332
Total, other adverse eventsVanoxerine 200mg322
Total, other adverse eventsVanoxerine 300mg825
Total, other adverse eventsVanoxerine 400mg1725
Total, serious adverse eventsPlacebo032
Total, serious adverse eventsVanoxerine 200mg122

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
25684233RESULT

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT01691313

GET https://conductscience.org/api/trials/v1/NCT01691313/events?page=2