Condition category
Circulatory System
Date applied
05/03/2012
Date assigned
04/04/2012
Last edited
21/05/2018
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 Yuri M Pozdnyakov

ORCID ID

Contact details

Moscow Regional Cardiology Centre
Zhukovsky
Frunze Street
1
Moscow
140180
Russian Federation

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

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

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

Publication citations

Additional files

Editorial Notes

21/05/2018: Publication reference added. 18/04/2018: Internal review. 28/03/2018: The publication and dissemination plan has been changed. 24/01/2018: Publication plan and IPD sharing statement added. 06/12/2017: results summary and publication reference added.