Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00993382

Purpose

The Primary Objective is to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.

Secondary Objectives:

To assess the tolerability and safety of the different dose regimens of celivarone in the selected population.
To document SSR149744 plasma levels during the study.

Condition	Intervention	Phase
Arrhythmia Prophylaxis	Drug: Celivarone (SSR149744) Drug: amiodarone Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to ICD shocks or deaths [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]
Time to Cardiovascular hospitalization or death [ Time Frame: up to 20 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	486
Study Start Date:	September 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
celivarone 50 mg od: Experimental Celivarone 50 mg once daily taken with a meal	Drug: Celivarone (SSR149744) Pharmaceutical form:capsules oral administration
celivarone 100 mg od: Experimental Celivarone 100 mg once daily taken with a meal	Drug: Celivarone (SSR149744) Pharmaceutical form:capsules oral administration
celivarone 300 mg od: Experimental Celivarone 300 mg once daily taken with a meal	Drug: Celivarone (SSR149744) Pharmaceutical form:capsules oral administration
amiodarone 600 mg/200 mg od: Active Comparator 600 mg once daily for 10 days (calibrator loading dose period) then 200 mg once daily taken with a meal	Drug: amiodarone Pharmaceutical form:capsules oral administration
placebo: Placebo Comparator undistinguishable with the experimental drug or the calibrator placebo capsules taken with a meal	Drug: placebo Pharmaceutical form:capsules oral administration

Detailed Description:

The study includes a one week screening period, followed by a treatment period scheduled for a minimum duration of 6 months for the last patient recruited.

The treatment period is going from the first day of treatment to the End of Treatment visit to be done 10-15 days prior to the Scheduled Study End Date (SSED). The SSED is expected to be about 190 days after the last patient randomization date.

The expected recruitment duration is about 14 months and thus the total duration of the study about 20 months. Visits are planned to be performed at baseline, after 5 days, after 14 days, every month for 6 months and then, every three months after 6 months until the end of the study.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria :

Implantable Cardioverter Defibrillator (ICD) patients with a Left Ventricular Ejection Fraction (LVEF) of 40% or less AND one of the following criteria:
- at least one ICD therapy for Ventricular Tachycardia (VT) OR
- Ventricular Fibrillation (VF) in the previous month OR
- ICD implantation in the previous month for documented VT/VF

Exclusion criteria :

Patients of either sex aged below 21 years (or the age of legal consent of the country),
Women of childbearing potential without adequate birth control or pregnant or breastfeeding women
Patients with known ICD lead problem (lead dislodgement)
ICD without the following characteristics :
- data logging function with cumulative counting of device intervention (shocks and antitachycardia pacing [ATP])
- electrogram storage capabilities
- ventricular demand pacing.
Recent unstable angina pectoris or myocardial infarction (< 4 weeks),
History of torsades de pointes,
Genetic channelopathies including congenital long QT syndrome,
Wolff-Parkinson-White syndrome,
Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intravenous pressor agents; patients on respirator; congestive heart failure of stage New York Heart Association (NYHA) IV within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization,
Incessant sustained VT/VF (VT/VF that recurs promptly despite termination attempts) during the three days preceding randomization.
Patients with inappropriate (not triggered by VT nor VF) shocks during the month preceding randomization.
Clinically relevant haematologic, hepatobiliary (ALT, AST > 3 times the upper limit of normal at randomization), gastro-intestinal, renal (serum creatinine > 221 µmol/l (2.5 mg/dl) at randomization), pulmonary, endocrinologic or psychiatric disease.
Patients treated with oral amiodarone (more than 20 tablets during the 2 months preceding randomization)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993382

Contacts

Contact: For site information, send an email with site number to

GV-Contact-us@sanofi-aventis.com

Show 146 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:

Peter KOWEY, Pr

Steering Committee Chair Person

More Information

No publications provided

Responsible Party:	sanofi-aventis ( International Clinical Development Study Director )
Study ID Numbers:	DRI10936, EudraCT:2008-008412-47
Study First Received:	October 9, 2009
Last Updated:	January 22, 2010
ClinicalTrials.gov Identifier:	NCT00993382 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Vasodilator Agents
Pathologic Processes
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Pharmacologic Actions
Amiodarone
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010