NCT00233441|CompletedPhase 2

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

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

Sanofi ClinicalTrials.gov

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1 other identifier

DRI5165

Study Type

interventional

Target

673

Locations

17 countries

Sites

Timeline

RegisteredOct 2005

StartedDec 2004

CompletionMay 2006

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

673

participants targeted

Target at P75+ for phase_2 atrial-fibrillation

Timeline

Completed

Started Dec 2004

Geographic Reach

17 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

December 1, 2004

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed

Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

October 4, 2005

Last Update Submit

May 7, 2012

Conditions

Atrial Fibrillation Atrial Flutter

Keywords

Atrial FibrillationAtrial FlutterArrhythmiaAnti-Arrhythmia Agents

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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.

Interventions

CELIVARONE (SSR149744C)DRUG

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.