Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00489736 | Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation | PHASE3 | COMPLETED | 504 | — | — | Jun 1, 2007 | Oct 1, 2008 | Feb 18, 2010 | 23 | United States, Argentina +21 |
| NCT00174785 | A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation | PHASE3 | COMPLETED | 4,628 | — | — | Jun 1, 2005 | Mar 1, 2008 | Jan 12, 2010 | 37 | United States, Argentina +35 |
| NCT00697086 | European Study of Dronedarone in Atrial Fibrillation | PHASE3 | COMPLETED | 174 | — | — | Aug 1, 2002 | Jun 1, 2004 | Jul 30, 2009 | 9 | Belgium, Czechia +7 |
| NCT00259376 | American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm | PHASE3 | COMPLETED | 629 | — | — | Nov 1, 2001 | Sep 1, 2003 | Feb 15, 2010 | 5 | United States, Argentina +3 |
| NCT00259428 | EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS) | PHASE3 | COMPLETED | 615 | — | — | Nov 1, 2001 | Aug 1, 2003 | Feb 9, 2010 | 12 | Belgium, Czechia +10 |
| NCT01213368 | Dose Ranging Study of Dronedarone for the Control of Ventricular Rate in Japanese Patients With Permanent Atrial Fibrillation | PHASE2 | COMPLETED | 181 | — | — | Sep 1, 2010 | Apr 1, 2011 | Oct 16, 2013 | 25 | Japan |
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 |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | matching placebo 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 (SR33589) | DRUG | oral administration |
| amiodarone | DRUG | oral administration |
| placebo | DRUG | oral administration (tablets) |
Inclusion Criteria: * Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation Exclusion Criteria: * Contraindication to oral anticoagulation * Patient hav...