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Also known as CELIVARONE (SSR149744C), SSR149744
CELIVARONE · 3 trials · 4 indications
The presence of VT or VF was documented by ICD interrogation leading to any ICD interventions (shocks or anti-tachycardia pacing). The 10 first ICD interventions for each patient were centrally and blindly adjudicated by an Adjudication Committee.
| Arm | Type | Description |
|---|---|---|
| Celivarone 50 mg | EXPERIMENTAL | Celivarone, 50 mg once daily up to 10-15 days before the common study end date |
| Celivarone 100 mg | EXPERIMENTAL | Celivarone, 100 mg once daily up to 10-15 days before the common study end date |
| Celivarone 300 mg | EXPERIMENTAL | Celivarone, 300 mg once daily up to 10-15 days before the common study end date |
| Amiodarone | ACTIVE_COMPARATOR | Amiodarone, 600 mg once daily for 10 days (loading dose) then 200 mg once daily up to 10-15 days before the common study end date |
| Placebo | PLACEBO_COMPARATOR | Matching placebo once daily up to 10-15 days before the common study end date |
| Name | Type | Description |
|---|---|---|
| Celivarone | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| Amiodarone | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| Matching placebo | DRUG | Pharmaceutical form: capsule Route of administration: oral Matching placebo added to active drug if any for a total of 3 capsules per intake |
| CELIVARONE (SSR149744C) | DRUG | - |
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 O...
Celivarone is an investigational small molecule developed by Sanofi for cardiovascular conditions, specifically arrhythmia prophylaxis and atrial fibrillation. It has been studied in Phase 2 clinical trials as a potential treatment to prevent arrhythmias and maintain normal heart rhythm. It is not approved for any indication.
Celivarone has been studied for arrhythmia prophylaxis and atrial fibrillation. Clinical trials evaluated its use for preventing implantable cardioverter defibrillator interventions or death, maintaining sinus rhythm in patients with recent atrial fibrillation or flutter, and converting atrial fibrillation or flutter to normal rhythm.
Celivarone is being developed by Sanofi, a global pharmaceutical company. Sanofi's ticker symbol is SNY. The company sponsored the Phase 2 clinical trials of celivarone.
Celivarone is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency. All trials of celivarone have been completed, and there are currently no active trials.
Celivarone has been studied in three completed Phase 2 trials: NCT00993382, a dose-ranging study for prevention of ICD interventions or death; NCT00233441, a placebo-controlled dose-ranging study for maintenance of sinus rhythm in atrial fibrillation/flutter; and NCT00232310, a dose-ranging study for conversion of atrial fibrillation/flutter.
Yes, celivarone is also known as SSR149744C. Both names refer to the same investigational drug developed by Sanofi. The alternative name SSR149744C appears in the clinical trial identifiers and study titles.