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

A Phase 3 study testing vernakalant hydrochloride in people with Atrial Fibrillation, run by Advanz Pharma.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: vernakalant hydrochloride
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 123 participants
Where: No sites listed yet
Study dates: Aug 2010to Oct 2012
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Abstinent or willing to use 2 acceptable methods of birth control
Patient has an atrial arrhythmia with dysrhythmic symptoms
Patient is receiving adequate anticoagulant therapy
Patient has stable blood pressure
Patient weighs between 45 and 136 kg (99 and 300 lbs)
Patient is adequately hydrated

Who cannot join

Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
Patient routinely consumes more than 2 alcoholic drinks per day
Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
Patient has severe aortic stenosis
Patient has atrial flutter

Show all 17Show fewer

Patient has Class IV congestive heart failure (CHF)
Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS)
Patient has had cardiac surgery within 30 days
Patient has known atrial thrombus
Patient has reversible causes of Atrial Fibrillation
Patient has failed electrical cardioversion during current episode of Atrial Fibrillation
Patient has uncorrected electrolyte imbalance
Patient has clinical evidence of digoxin toxicity
Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days
Patient is known to be HIV positive
Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers

About this study

Official title: A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation

Read the detailed description

Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Conditions: Atrial Fibrillation
Being tested: vernakalant hydrochloride, Placebo to vernakalent hydrochloride
Keywords: Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vernakalant hydrochlorideDrug
Also called MK-6621
Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.
Placebo to vernakalent hydrochlorideDrug
Also called Saline
Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.

Study groups in NCT01174160
Study group	Role	What they receive
vernakalant HCl	Experimental	vernakalant hydrochloride Receives: Drug: vernakalant hydrochloride
placebo	Placebo comparator	placebo Receives: Drug: Placebo to vernakalent hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Oct 2012

First posted3 Aug 2010 (estimated)
Study startAug 2010
Primary completionSep 2012
Study completionOct 2012

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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01174160
Sponsor's protocol ID: 6621-010
Status last verified: Nov 2015
First submitted: 30 Jul 2010
Last updated: 15 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT01174160
Acronym / sponsor ID: 6621-010
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Advanz PharmaIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 3 Aug 2010 (estimated)
Results: Posted 15 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
vernakalant HCl	Experimental	Drug: vernakalant hydrochloridevernakalant hydrochloride
placebo	Placebo comparator	Drug: Placebo to vernakalent hydrochlorideplacebo

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Abstinent or willing to use 2 acceptable methods of birth control
Patient has an atrial arrhythmia with dysrhythmic symptoms
Patient is receiving adequate anticoagulant therapy
Patient has stable blood pressure
Patient weighs between 45 and 136 kg (99 and 300 lbs)

Key exclusion criteria (17 listed)

Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
Patient routinely consumes more than 2 alcoholic drinks per day
Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
Patient has severe aortic stenosis

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
vernakalant hydrochlorideAlso: MK-6621Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.	Drug	vernakalant HCl
Placebo to vernakalent hydrochlorideAlso: SalinePatients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.	Drug	placebo

Primary outcome

Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
Time frame: 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

Results and safety

Results posted to the registry on 15 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vernakalant IV	61	53
Placebo	62	56

Primary outcome: Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm

Time frame: Within 90 minutes after first exposure. Number. Unit: participants

Measure	Vernakalant IV n = 55	Placebo n = 56
Value	29	7

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vernakalant IV	6 of 55 (10.9%)	23 of 55 (41.8%)	Not reported
Placebo	6 of 56 (10.7%)	23 of 56 (41.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vernakalant hydrochloride in people with Atrial Fibrillation, run by Advanz Pharma.

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: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

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 15 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?

Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm (time frame: Within 90 minutes after first exposure). 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 NCT01174160.

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 15 Dec 2015.