Status:
COMPLETED
Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death
Lead Sponsor:
Sanofi
Conditions:
Arrhythmia Prophylaxis
Ventricular Arrhythmia
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary objectives were: * To assess the t...
Detailed Description
The study included a one week screening period, followed by a treatment period ranging between 6 and 19 months. The treatment was to be continued until the End of Treatment visit scheduled 10-15 days...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Implantable Cardioverter Defibrillator (ICD) patients with a Left Ventricular Ejection Fraction (LVEF) of 40% or less AND one of the following criteria:
- at least one ICD therapy for Ventricular Tachycardia (VT) OR
- Ventricular Fibrillation (VF) in the previous month OR
- ICD implantation in the previous month for documented VT/VF
- Exclusion criteria :
- Patients of either sex aged below 21 years (or the age of legal consent of the country),
- Women of childbearing potential without adequate birth control or pregnant or breastfeeding women
- Patients with known ICD lead problem (lead dislodgement)
- ICD without the following characteristics :
- data logging function with cumulative counting of device intervention (shocks and anti-tachycardia pacing \[ATP\])
- electrogram storage capabilities
- ventricular demand pacing.
- Recent unstable angina pectoris or myocardial infarction (\< 4 weeks),
- History of torsades de pointes,
- Genetic channelopathies including congenital long QT syndrome,
- Wolff-Parkinson-White syndrome,
- Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intravenous pressor agents; patients on respirator; congestive heart failure of stage New York Heart Association (NYHA) IV within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization,
- Incessant sustained VT/VF (VT/VF that recurs promptly despite termination attempts) during the three days preceding randomization.
- Patients with inappropriate (not triggered by VT nor VF) shocks during the month preceding randomization.
- Clinically relevant haematologic, hepatobiliary (ALT, AST \> 3 times the upper limit of normal at randomization), gastro-intestinal, renal (serum creatinine \> 221 µmol/l (2.5 mg/dl) at randomization), pulmonary, endocrinologic or psychiatric disease.
- Patients treated with oral amiodarone (more than 20 tablets during the 2 months preceding randomization)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT00993382
Start Date
September 1 2009
End Date
May 1 2011
Last Update
May 30 2016
Active Locations (151)
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1
Investigational Site Number 840006
Huntsville, Alabama, United States, 35801
2
Investigational Site Number 840042
Mobile, Alabama, United States, 36608
3
Investigational Site Number 840014
Mesa, Arizona, United States, 85206
4
Investigational Site Number 840032
Phoenix, Arizona, United States, 85006