Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT01213368
Brief Summary:
Primary Objective:
\- To assess the efficacy of dronedarone versus placebo for the control of ventricular rate in patients with permanent Atrial Fibrillation (AF).
Secondary Objective:
* To assess the safety and tolerability of dronedarone after repeated oral doses of 300 mg, 400 mg, or 600 mg twice daily in the selected population.
* To document SR33589 and SR35021 trough plasma levels at steady state.
Detailed Description:
The study period per patient is approximatively 1 month broken down as follows:
* Screening period up to 7 days,
* Treatment period of 14 days,
* Follow-up period of 10 days.
Study:
NCT01213368
Study Brief:
Protocol Section:
NCT01213368