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

Arrhythmia Clinical Trial

— ICARIOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232297
• Other study ID #: DRI5349
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: May 7, 2012
• Start date: June 2005
• Est. completion date: February 2007

Study information

• Verified date: May 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

Intervention

Drug:
• SSR149744C

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Switzerland	Sanofi-Aventis Administrative Office	Geneva
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Germany,  Italy,  Netherlands,  Switzerland, 

References & Publications (1)

Gojkovic O, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Singh BN, Kowey PR. Celivarone in patients with an implantable cardioverter-defibrillator: adjunctive therapy for the reduction of ventricular arrhythmia- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock).
Secondary	Time to all arrhythmia episodes leading to at least one documented ICD shock.

External Links

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