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ISRCTN
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ISRCTN14227980
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ClinicalTrials.gov identifier
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Public title
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Evaluation of the anti-arrhythmic effects of 3 dosages of S 44121 versus placebo in patients with chronic heart failure at risk for ventricular arrhythmia
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Scientific title
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Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia: a 12-week, randomised, double-blind, parallel-group, placebo controlled, international multicentre study
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Acronym
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N/A
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Serial number at source
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CL2-44121-006
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Study hypothesis
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To evaluate the anti-arrhythmic efficacy of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction for prevention of ventricular arrhythmia.
As of 15/03/2011 the anticipated end date for this trial has been increased from 31/07/2011 to 31/12/2011.
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Lay summary
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Ethics approval
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Ethic approval was obtained before recruitment of the first participants
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Study design
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Randomised double-blind parallel-group placebo controlled international multicentre study
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Countries of recruitment
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Australia, Canada, Czech Republic, France, Germany, Hungary, Poland, Portugal, Slovakia, Spain, United Kingdom
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Disease/condition/study domain
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Cardiac arrhythmia in chronic heart failure
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Participants - inclusion criteria
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1. Both genders patients between 18 years or legal age and 80 years
2. Symptomatic chronic heart failure for at least 6 months
3. Ischaemic disease or idiopathic dilated cardiomyopathy as main cause for chronic heart failure
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Participants - exclusion criteria
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1. Woman who are pregnant, breast-feeding or not using a contraception
2. Recent myocardial infarction, unstable angina or coronary revascularisation less than 3 months before selection
3. History of stroke or cerebral transient ischemic attack within the previous 3 months before selection
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Anticipated start date
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01/03/2010
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Anticipated end date
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31/12/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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160
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Interventions
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A 2-week run-in period followed by 12-week randomised double-blind period of S 44121 versus placebo, and a 2-week follow-up period.
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Primary outcome measure(s)
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Efficacy measurements recorded on the Holter ECG, measured at at inclusion visit and 1 week, 4 weeks and 12 weeks of treatment
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Secondary outcome measure(s)
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1. Safety profile measured by 12-lead resting ECG, measured at each visit
2. Physical examination, measured at each visit
3. Adverse events, recorded throughout the study
4. Blood clinical laboratory parameters, measured at at inclusion visit and after 12 weeks of treatment
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Sources of funding
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Institut de Recherches Internationales Servier (France)
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Trial website
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Publications
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Contact name
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Prof
J
Camm
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Address
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St. Georges' University of London
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Sponsor
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Institut de Recherches Internationales Servier (France)
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Address
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Valérie Fautrier
6, place des Pléiades
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City/town
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Courbevoie
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Zip/Postcode
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92415
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Country
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France
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Date applied
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27/04/2010
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Last edited
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15/03/2011
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Date ISRCTN assigned
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21/05/2010
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