Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

Phase 2/3 Completed 673 enrolled Sanofi

RandomizedParallel-groupDouble-blindTreatment

Summary

Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

Timeline

Start: 2004-12
Primary completion: 2006-05
Completion: 2006-05

Publications

Results Khitri AR, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Kowey PR. Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter. J Cardiovasc Electrophysiol. 2012 May;23(5):462-72. doi: 10.1111/j.1540-8167.2011.02234.x. Epub 2011 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celivarone	Small molecule	50 mg	—
Subject	Celivarone	Small molecule	100 mg	—
Subject	Celivarone	Small molecule	200 mg	—
Subject	Celivarone	Small molecule	300 mg	—

Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

Summary

Timeline

Publications

Drugs

Indications