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| ID | Type | Description | Link |
|---|---|---|---|
| SR33589B |
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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.
This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study.
To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronedarone 400mg bid | Experimental | dronedarone 400mg tablets |
|
| Placebo | Experimental | matching placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronedarone (SR33589) | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence |
| Measure | Description | Time Frame |
|---|---|---|
| - AF/AFL related symptoms collected at the time of ECG/TTEM recording, | ||
| - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM) | ||
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Inclusion Criteria:
Exclusion Criteria:
Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17804843 | Result | Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99. doi: 10.1056/NEJMoa054686. | |
| 35717354 | Derived | Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8. |
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| placebo | Drug | oral administration |
|
| - time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording. |
| Buenos Aires |
| Argentina |
| sanofi-aventis Australia administrative office | Macquarie Park | Australia |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077764 | Dronedarone |
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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