CLINICAL TRIALS PROFILE FOR MULTAQ
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All Clinical Trials for MULTAQ
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01026090 ↗ | Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA) | Terminated | Sanofi | Phase 4 | 2009-11-01 | Primary Objective: To determine whether daily administration of dronedarone started 5-7 days before cardioversion is superior to dronedarone started only after cardioversion with respect to the absence of symptomatic, ECG confirmed, atrial fibrillation (AF) recurrence over 6 months in adult patients with persistent AF, for whom cardioversion is clinically indicated and planned to reduce symptoms and antiarrhythmic treatment is clinically indicated to reduce the risk of cardiovascular hospitalization due to AF. Secondary Objectives: Main Secondary : - To assess the number of symptomatic AF recurrences/patient/6 months with and without ECG confirmation; - To assess characteristics of symptomatic AF recurrence in the two treatment arms (frequency, duration of episodes, type, number, and severity of AF symptoms per patient); - To compare the rates of early recurrences of AF between the two treatment strategies; Other secondary: - To assess whether there is a difference in proportion of patients with symptomatic AF recurrences (with and without ECG confirmation) between the two treatment strategies; - To assess whether there is a difference in number of electrical cardioversions per patient between the two treatment strategies; - To assess the impact of the two strategies on number of shocks, cumulative amount of energy delivered, shock failure, and immediate success of cardioversion; - To assess whether there is a difference in rate of cardiovascular (CV) hospitalizations and length of hospital stay between the two treatment strategies; - To assess whether there is a difference in quality of life between the two treatment strategies. |
| NCT01047566 ↗ | Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE) | Completed | Sanofi | Phase 4 | 2010-04-01 | The primary objective of this study is to: Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy. The secondary objectives of this study are to compare both study arms with regard to: - Ventricular rate after 3 months - Number of registered AF episodes - Number of symptomatic AF episodes - Severity of AF and AF-like symptoms - Rate of premature study discontinuation - Number of symptomatic episodes of bradycardia - Incidence of low heart rate (<60 bpm) |
| NCT01070667 ↗ | Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation | Unknown status | Eastbourne General Hospital | Phase 4 | 2010-03-01 | The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months. |
| NCT01151137 ↗ | Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy | Terminated | Sanofi | Phase 3 | 2010-07-01 | Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death). |
| NCT01182376 ↗ | SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI | Completed | Sanofi | Phase 3 | 2010-11-01 | The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging. |
| NCT01182376 ↗ | SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI | Completed | University of Utah | Phase 3 | 2010-11-01 | The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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