Brief Summary

Primary objective:

to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions. Secondary objectives:
to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population.
to document SSR149744C plasma level during the study.

Trial Health

On Track

Trial Health Score

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

Enrollment

153

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2005

Geographic Reach

8 countries

8 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

1.7 years study duration

Study Start

First participant enrolled

June 1, 2005

Completed

4 months 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

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed

Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1.7 years

First QC Date

October 3, 2005

Last Update Submit

May 7, 2012

Conditions

Arrhythmia Tachycardia, Ventricular Ventricular Fibrillation

Keywords

Tachycardia, VentricularVentricular FibrillationDefibrillators ImplantableArrhythmiaAnti-arrhythmia agents

Outcome Measures

Primary Outcomes (1)

Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock).

Secondary Outcomes (1)

Time to all arrhythmia episodes leading to at least one documented ICD shock.

Interventions

SSR149744CDRUG

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patient with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia OR implanted with an ICD and with at least one appropriate ICD therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year.
Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months.

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, severe associated conditions.

Contact the study team to confirm eligibility.