Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DRONEDARONE · 7 trials · 2 indications
The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
The primary event is the first hospitalization for cardiovascular reason or death from any cause, whichever is earlier, as assessed by the investigator. The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Half of the patients will be assigned placebo. |
| Multaq® (dronedarone) | EXPERIMENTAL | Half of the patients will be prescribed dronedarone. |
| Dronedarone 400mg bid | EXPERIMENTAL | dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg |
| Amiodarone 600mg/200mg od | ACTIVE_COMPARATOR | over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| dronedarone 300 mg | EXPERIMENTAL | Dronedarone, 100mg + 200mg tablets twice daily, administered with food. |
| dronedarone 400 mg | EXPERIMENTAL | Dronedarone, 400mg tablets twice daily, administered with food. |
| dronedarone 600 mg | EXPERIMENTAL | Dronedarone, 400mg + 200mg tablets twice daily, administered with food. |
| Name | Type | Description |
|---|---|---|
| dronedarone | DRUG | Dronedarone will be prescribed by the patient's team according to established guidelines. |
| Placebo | DRUG | Placebo will be administered by the patient's team according to established guidelines. |
| dronedarone (SR33589) | DRUG | oral administration |
| amiodarone | DRUG | oral administration |
Inclusion Criteria: * Patients age 18 and older * Must carry a diagnosis of Paroxysmal Atrial Fibrillation for 1 months or longer prior to being enrolled. * AAD: Multaq® (dronedarone) candidate * Patients have given informed consent Exclusion Criteria: * Patients who are unavailable to continue f...
Dronedarone is a small molecule cardiovascular drug being developed by Sanofi for the treatment of atrial fibrillation and atrial flutter. It is currently in Phase 3 clinical development and is being studied to prevent hospitalization or death in patients with these conditions.
Dronedarone is a small molecule antiarrhythmic agent. Its mechanism of action involves multiple ion channel and receptor targets, though the specific molecular target is not detailed here. It is being studied for its effects on heart rhythm in patients with atrial fibrillation.
Dronedarone is being developed by Sanofi, a global pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in treating atrial fibrillation and atrial flutter.
Dronedarone is currently in Phase 3 clinical development. It has completed seven clinical trials with a total enrollment of 6,764 participants. All completed trials were randomized, double-blind, and placebo-controlled, though the drug is still investigational and not yet approved.
Dronedarone has been studied in several completed clinical trials. Notable ones include NCT00174785, a Phase 3 trial with 4,628 patients evaluating prevention of hospitalization or death in atrial fibrillation, and NCT00259428, a Phase 3 trial with 615 patients studying maintenance of sinus rhythm. Both trials were completed.
Dronedarone is also known by the brand name Multaq. It is a small molecule drug developed by Sanofi for the treatment of atrial fibrillation and atrial flutter. The drug has been studied in multiple Phase 3 clinical trials to assess its ability to reduce cardiovascular hospitalization and maintain normal heart rhythm.