Trial · NCT01174160

A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)

NCT01174160, Phase 3, Completed, Advanz Pharma; results first posted 2015-12-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4). Trials, record NCT01174160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01174160

On this page

Trial

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

Title: A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)
NCT number: NCT01174160
Status: Completed
Phases: Phase 3
Enrollment: 123 participants, actual
Lead sponsor: Advanz Pharma
Conditions: Atrial Fibrillation
Interventions: vernakalant hydrochloride, Placebo to vernakalent hydrochloride
First posted: 2010-08-03
Last updated: 2015-12-15
Results first posted: 2015-12-15

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm	Within 90 minutes after first exposure	The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm	Within 90 minutes after first exposure		participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm	Vernakalant IV		29		participants
Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm	Placebo		7		participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vernakalant IV	61
Overall Study	STARTED	Placebo	62
Overall Study	Discontinued Pre Dose	Vernakalant IV	6
Overall Study	Discontinued Pre Dose	Placebo	6
Overall Study	Dosed	Vernakalant IV	55
Overall Study	Dosed	Placebo	56
Overall Study	Discontinued Post Dose	Vernakalant IV	2
Overall Study	Discontinued Post Dose	Placebo	0
Overall Study	COMPLETED	Vernakalant IV	53
Overall Study	COMPLETED	Placebo	56

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events130

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
other	Bradycardia	Cardiac disorders	Vernakalant IV	4	55
other	Bradycardia	Cardiac disorders	Placebo	2	56
other	Ventricular tachycardia	Cardiac disorders	Vernakalant IV	1	55
other	Ventricular tachycardia	Cardiac disorders	Placebo	4	56
other	Sick sinus syndrom	Cardiac disorders	Vernakalant IV	2	55
other	Sick sinus syndrom	Cardiac disorders	Placebo	0	56
other	Hypertensive heart disease	Cardiac disorders	Vernakalant IV	1	55
other	Hypertensive heart disease	Cardiac disorders	Placebo	0	56
other	Palpitations	Cardiac disorders	Vernakalant IV	1	55
other	Palpitations	Cardiac disorders	Placebo	0	56

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vernakalant IV
Total, all-cause mortality	Placebo
Total, other adverse events	Vernakalant IV	23	55
Total, other adverse events	Placebo	23	56
Total, serious adverse events	Vernakalant IV	6	55
Total, serious adverse events	Placebo	6	56

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
Vernakalant IV vs Placebo: Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm	Trial comparisons
Vernakalant IV 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.

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/NCT01174160

GET https://conductscience.org/api/trials/v1/NCT01174160/events?page=2

API reference For AI assistants