Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

Completed · Phase 2 · Has a placebo group

Conditions studied: Arrhythmia Prophylaxis, Ventricular Arrhythmia

In brief

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 tolerability and safety of the different dose regimens of Celivarone in the selected population. * To document Celivarone plasma levels during the study.

Key facts

Study ID

NCT00993382

Run by

Sanofi

People needed

486

Starts

2009-09-01

Expected to finish

2011-05-01

Last updated by the study team

2016-05-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840042 — Mobile, Alabama, United States
• Investigational Site Number 840014 — Mesa, Arizona, United States
• Investigational Site Number 840032 — Phoenix, Arizona, United States
• Investigational Site Number 840033 — Tucson, Arizona, United States
• Investigational Site Number 840054 — Redondo Beach, California, United States
• Investigational Site Number 840007 — Redwood City, California, United States
• Investigational Site Number 840039 — Colorado Springs, Colorado, United States
• Investigational Site Number 840002 — Fort Myers, Florida, United States
• Investigational Site Number 840010 — Orlando, Florida, United States
• Investigational Site Number 840005 — Port Charlotte, Florida, United States
• Investigational Site Number 840013 — St. Petersburg, Florida, United States
• Investigational Site Number 840043 — St. Petersburg, Florida, United States
• Investigational Site Number 840004 — Augusta, Georgia, United States
• Investigational Site Number 840045 — Chicago, Illinois, United States
• Investigational Site Number 840035 — Lombard, Illinois, United States
• Investigational Site Number 840017 — Kansas City, Kansas, United States
• Investigational Site Number 840022 — Scarborough, Maine, United States
• Investigational Site Number 840009 — Ann Arbor, Michigan, United States
• Investigational Site Number 840026 — Detroit, Michigan, United States
• Investigational Site Number 840003 — Petoskey, Michigan, United States
• Investigational Site Number 840015 — Ypsilanti, Michigan, United States
• Investigational Site Number 840049 — Columbia, Missouri, United States
• Investigational Site Number 840019 — Kansas City, Missouri, United States
• Investigational Site Number 840031 — New York, New York, United States
• Investigational Site Number 840006 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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