Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CL3-06795-008
Study information
Scientific title
Clinical acceptability of trimetazidine 80 mg once daily compared to trimetazidine 35 mg twice daily in patients with chronic stable angina pectoris: a multicentre randomised double blind study
Acronym
Study hypothesis
To compare the clinical acceptability of trimetazidine 80mg once daily with trimetazidine 35 mg twice daily
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
International multicentre randomised double-blind parallel-group 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
Angina pectoris attacks
Intervention
A randomised, double-blind, parallel-group study in patients treated for 12 weeks - Two arms: trimetazidine MR 80mg once daily or trimetazidine MR 35mg twice daily
Intervention type
Drug
Phase
Not Applicable
Drug names
Trimetazidine
Primary outcome measure
1. Emergent adverse events
2. Blood pressure
3. Weight
4. Laboratory examinations: biochemical and haematological parameters
5.12-lead electrocardiogram
6. CCS classification of symptoms of angina pectoris
Secondary outcome measures
No secondary outcome measures
Overall trial start date
12/03/2012
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female patient
2. More than or equal to 21 years old
3. Any ethnic origin
4. Patients with a prior diagnosis of stable angina pectoris of effort
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. History of acute coronary syndrome within previous 3 months
2. Coronary revascularisation procedure within previous 3 months
3. Canadian Cardiovascular Society (CCS) class 4 angina pectoris
Recruitment start date
12/03/2012
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Russian Federation, Serbia
Trial participating centre
Moscow Regional Cardiology Centre
Moscow
140180
Russian Federation
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
Current version as of 28/03/2018:
Summary results are published in https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
Previous version as of 24/01/2018:
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL3-06795-008_synopsis_report.pdf
Publication list
2016 poster presentation on http://congress365.escardio.org/Search-Results?vgnextkeyword=C365PRESENTATION140761#.WXi-uriLS70
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29779201