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OpenTrials
Completed

NCT Number: NCT00232297

Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

SSR149744C

Drug

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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Acronym: ICARIOS

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 4, 2005
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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