NCT00232310|CompletedPhase 2

Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr

CORYFEE

Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter

Sanofi ClinicalTrials.gov

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1 other identifier

DRI5760

Study Type

interventional

Target

150

Locations

9 countries

Sites

Timeline

RegisteredOct 2005

StartedOct 2005

CompletionApr 2006

Brief Summary

Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.

Trial Health

On Track

Trial Health Score

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

Enrollment

150

participants targeted

Target at P50-P75 for phase_2 atrial-fibrillation

Timeline

Completed

Started Oct 2005

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach

9 countries

9 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

6 months study duration

Study Start

First participant enrolled

October 1, 2005

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed

Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

October 3, 2005

Last Update Submit

May 7, 2012

Conditions

Atrial Fibrillation Atrial Flutter

Keywords

Atrial FibrillationAtrial FlutterElectric Countershock

Outcome Measures

Primary Outcomes (1)

The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.

Secondary Outcomes (1)

The secondary efficacy endpoint will be the mean ventricular rate during AF/AFL on the 12-lead ECG performed just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.

Interventions

CELIVARONE (SSR149744C)DRUG

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

AF/AFL for \>72 hours and documented by 2 12-lead ECGs separated by at least 72 hours and indication for electrical cardioversion of the current AF/AFL episode as judged by the investigator.

You may not qualify if:

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

Contact the study team to confirm eligibility.