Исследования / № 00668759
|Краткое название||A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation|
|Полное название||A Phase III Prospective, Randomized, Double-Blind, Active-Controlled, Multi-Center, Superiority Study of Vernakalant Injection Versus Amiodarone in Subjects With Recent Onset Atrial Fibrillation|
|Под контролем||Australia: Department of Health and Ageing Therapeutic Goods Administration|
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - French Health Products Safety Agency
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Sweden: Medical Products Agency
Ukraine: Ministry of Health
|Краткое описание||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 minutes of the start of drug administration. The secondary objective
is to compare the safety of vernakalant to amiodarone.
|Дата начала||April 2008|
|Подробное описание||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 injection or amiodarone injection in a
Safety will be assessed through the monitoring of adverse events, vital signs, continuous
telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.
At 2 hours after the start of infusion, electrical cardioversion may be performed or rate
control medication may be administered. Class I and Class III antiarrhythmics are not to be
administered for 24 hours after the start of infusion.
Subjects are to remain in the clinic for at least 6 hours after the start of infusion.
Subjects will attend a follow-up visit at 7 (?±2) days after treatment and will receive a
follow-up telephone call at 30 (?±3) days for assessment of serious adverse events,
concomitant medications related to serious adverse events, and recurrence of AF.
All roles were blinded with the exception of each site's designated unblinded personnel who
were responsible for randomization and preparation, dispensation and accountability of the
Expanded Access was not available through this protocol.
|Вид исследования||Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment|
|Критерии||Key Inclusion Criteria:|
- 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 .
- 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 Criteria:
- 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.
|Минимальный возраст||18 Years|
|Максимальный возраст||85 Years|
|Контакты и расположение|
|Donetsk||Donetsk Regional Clinical Hospital|
|Kharkiv||City Clinical Hospital #8|
|Kiev||Kiev City Clinical Hospital No 5, Coronary Care Unit|
|Kiev||City Clinical Hospital #1 Intensive Care Unit|
|Kiev||N.D. Strazhesko Institute of Cardiology Intensive Care Unit|
|Lugansk||Lugansk First Clinical Multiprofile Hospital #1, Cardiology|
|Lviv||Lviv Reg St Clinical Treat-and-Diagn Cardio. Centre Dept of Myocardial Infarction|
|Odessa||City Clinical Hospital #9 Dept of Arrhythmia|