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)
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation; Atrial Flutter
Intervention: SSR149744C (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL.
Secondary outcome: The secondary endpoints will be the following:time from randomization to first symptomatic AF/AFL recurrence - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence.
Detailed 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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Chilly 91380, France
Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: December 2004
Last updated: September 29, 2006
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