Condition category
Circulatory System
Date applied
27/04/2010
Date assigned
21/05/2010
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof J Camm

ORCID ID

Contact details

St. Georges' University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

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.

As of 15/03/2011 the anticipated end date for this trial has been increased from 31/07/2011 to 31/12/2011.

Please note that as of 29/11/2012, the following changes were made to the record:
1. Argentina, Belgium, Netherlands, Taiwan, Korea and Singapore were added to the countries of recruitment
2. The anticipated end date for this trial was updated from 31/12/2011 to 28/02/2013

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 below 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 measures

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

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

Participant exclusion criteria

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

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

http://www.servier.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/09/2016: Internal review