A Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation (AF) (MK-6621-055)
NCT ID: NCT01627106
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2012-09-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vernakalant
Vernakalant
Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered.
Amiodarone
Amiodarone
Administered IV as per product label
Interventions
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Vernakalant
Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered.
Amiodarone
Administered IV as per product label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
* Weigh at least 45 kg
* Receiving adequate anticoagulant therapy
Exclusion Criteria
* Severe aortic stenosis
* Systolic blood pressure \<100 mmHg
* New York Heart Association (NYHA) Class III or IV heart failure
* Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
* Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration
* Acute coronary syndrome (including myocardial infarction) within previous 30 days
* History of thyroid dysfunction
* Severe acute respiratory failure or cardiovascular collapse
* Participating in another drug study or has received an investigational drug within 30 days prior to enrollment
* Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
18 Years
ALL
No
Sponsors
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Advanz Pharma
INDUSTRY
Responsible Party
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Other Identifiers
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6621-055
Identifier Type: -
Identifier Source: org_study_id