Additional identifiers
EudraCT number
2009-014940-12
ClinicalTrials.gov number
Protocol/serial number
CL2-44121-006
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind parallel-group placebo-controlled international multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cardiac arrhythmia in chronic heart failure
Intervention
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.
Intervention type
Drug
Phase
Phase II
Drug names
S 44121
Primary outcome measure
Efficacy measurements recorded on the Holter ECG, measured at at inclusion visit and 1 week, 4 weeks and 12 weeks of treatment
Secondary outcome measures
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
Overall trial start date
01/03/2010
Overall trial end date
28/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Total final enrolment
149
Participant exclusion criteria
1. Women who are pregnant, breast-feeding or not using 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
Recruitment start date
01/03/2010
Recruitment end date
28/02/2013
Locations
Countries of recruitment
Argentina, Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Korea, South, Netherlands, Poland, Portugal, Singapore, Slovakia, Spain, Taiwan, United Kingdom
Trial participating centre
St. Georges' University of London
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL2-44121-006_synopsis_report.pdf
https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-014940-12/results (added 20/04/2020)
Publication list