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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)

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: October 4, 2005
Last updated: May 7, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Enrollment: 673
Study Start Date: December 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00233441

  Show 17 Study Locations
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00233441     History of Changes
Other Study ID Numbers: DRI5165
Study First Received: October 4, 2005
Last Updated: May 7, 2012

Keywords provided by Sanofi:
Atrial Fibrillation
Atrial Flutter
Anti-Arrhythmia Agents

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors processed this record on April 28, 2017