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Last Updated: February 7, 2023

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 >Phase >Start Date >Summary

Clinical Trial Conditions for Multaq

Condition Name

Condition Name for Multaq
Intervention Trials
Atrial Fibrillation 5
Paroxysmal Atrial Fibrillation 1
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Condition MeSH

Condition MeSH for Multaq
Intervention Trials
Atrial Fibrillation 6
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Clinical Trial Locations for Multaq

Trials by Country

Trials by Country for Multaq
Location Trials
Netherlands 2
Canada 2
United Kingdom 2
Finland 1
Italy 1
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Trials by US State

Trials by US State for Multaq
Location Trials
New Jersey 1
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Clinical Trial Progress for Multaq

Clinical Trial Phase

Clinical Trial Phase for Multaq
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Multaq
Clinical Trial Phase Trials
Terminated 2
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for Multaq

Sponsor Name

Sponsor Name for Multaq
Sponsor Trials
Sanofi 5
Eastbourne General Hospital 1
University of Utah 1
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Sponsor Type

Sponsor Type for Multaq
Sponsor Trials
Industry 5
Other 4
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