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 (MAIA)

Sanofi

Status and phase

Completed

Phase 3

Phase 2

Conditions

Atrial Flutter

Atrial Fibrillation

Treatments

Drug: CELIVARONE (SSR149744C)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233441

DRI5165

Details and patient eligibility

About

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.

Full description

This is a dose-ranging multicenter, multinational, randomized, double-blind, placebo-controlled, parallel arm study with 4 SSR149744C dose regimens and amiodarone as a calibrator.To be eligible, patients must be in normal sinus rhythm for at least one hour at randomization and must have an electrocardiogram documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.

Enrollment

673 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 21 years or more of either sex with documented sinus rhythm for at least 1 hour at the time of randomization with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion criteria

MAIN CRITERIA (non-exhaustive list):Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, contraindications to amiodarone, conditions which increase the risk of severe antiarrhythmic drug side effects, severe left ventricular dysfunction, severe associated conditions.