CLINICAL TRIALS PROFILE FOR DRONEDARONE HYDROCHLORIDE
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All Clinical Trials for Dronedarone Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00174785 ↗ | A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial Fibrillation | Completed | Sanofi | Phase 3 | 2005-06-01 | To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL). To assess that dronedarone is well tolerated in this population. |
| NCT00259376 ↗ | American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm | Completed | Sanofi | Phase 3 | 2001-11-01 | To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence. To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms. |
| NCT00259428 ↗ | EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS) | Completed | Sanofi | Phase 3 | 2001-11-01 | To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms. To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence. |
| NCT00489736 ↗ | Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation | Completed | Sanofi | Phase 3 | 2007-06-01 | The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation. |
| NCT00696631 ↗ | European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure | Terminated | Sanofi | Phase 3 | 2002-06-01 | The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular dysfunction (LVD) when added to evidence based treatments for CHF. |
| NCT00697086 ↗ | European Study of Dronedarone in Atrial Fibrillation | Completed | Sanofi | Phase 3 | 2002-08-01 | The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerability of dronedarone in the target population. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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