Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for cardiovascular conditions, specifically for arrhythmia prophylaxis and atrial fibrillation. It has been studied for the conversion of atrial fibrillation or flutter and for the maintenance of sinus rhythm in patients with recent atrial fibrillation or flutter.
CELIVARONE is being developed by Sanofi, a multinational pharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The drug is currently in Phase 2 clinical development.
CELIVARONE is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for CELIVARONE are Phase 2 studies, and the drug remains under investigation for its safety and efficacy.
CELIVARONE has completed three Phase 2 clinical trials. These include NCT00232310, a dose-ranging study for conversion of atrial fibrillation or flutter; NCT00233441, a study for maintenance of sinus rhythm; and NCT00993382, a study for prevention of implantable cardioverter defibrillator interventions or death.
CELIVARONE is a small molecule drug candidate. Its specific molecular target has not been disclosed in available information. It is being studied for its potential to treat arrhythmias, including atrial fibrillation and ventricular arrhythmias.
CELIVARONE is also known as SSR149744C. In clinical trial records, the drug is referred to by both names. For example, NCT00232310 and NCT00233441 use the designation SSR149744C in their titles, while NCT00993382 uses the name Celivarone.