Status:
COMPLETED
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation
Lead Sponsor:
Advanz Pharma
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to demonstrate the superiority of vernakalant injection over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) within 90 min...
Detailed Description
This is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in subjects with symptomatic AF of 3 to 48 hours duration. Subjects will be randomized to receive vernakalant i...
Eligibility Criteria
Inclusion
- Key
- Have symptomatic AF of 3 to 48 hours duration at baseline.
- Be eligible for cardioversion.
- Have adequate anticoagulation therapy for cardioversion in accordance with standard of practice as recommended by ACC/AHA/ESC guidelines \[1\].
- Be hemodynamically stable and have systolic blood pressure (BP) above 100 mmHg and less than 160 mmHg and diastolic BP less than 95 mmHg at screening and baseline.
- Key
Exclusion
- Known or suspected prolonged QT or uncorrected QT interval of \>440 msec as measured at screening on a 12 lead ECG, familial long QT syndrome, or previous torsades de pointes, ventricular fibrillation; or sustained ventricular tachycardia (VT).
- Symptomatic bradycardia, sick sinus syndrome, or ventricular rate less than 50 beats per minute (bpm) as documented by 12-lead ECG at screening.
- A QRS interval \>140 msec.
- Atrial flutter.
- Significant valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis.
- Documented previous episodes of second or third degree atrioventricular (AV) block.
- Had a myocardial infarction (MI), acute coronary syndrome or cardiac surgery within 30 days prior to entry into the study.
- Uncorrected electrolyte imbalance of serum potassium or magnesium. Both K+ and Mg2+ must be corrected prior to dosing.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00668759
Start Date
April 1 2008
End Date
November 1 2009
Last Update
December 15 2009
Active Locations (100)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Royal Hobart Hospital Cardiology Research
Hobart, Tasmania, Australia, 7000
3
Launceston General Hospital Cardiac Research Unit
Launceston, Tasmania, Australia
4
Royal Perth Hospital Emergency Research
Perth, Western Australia, Australia, 6000