Clinical acceptability of trimetazidine 80 mg once daily compared to trimetazidine 35 mg twice daily in patients with chronic stable angina pectoris
| ISRCTN | ISRCTN84362208 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84362208 |
| Secondary identifying numbers | CL3-06795-008 |
- Submission date
- 05/03/2012
- Registration date
- 04/04/2012
- Last edited
- 21/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Yuri M Pozdnyakov
Scientific
Scientific
Moscow Regional Cardiology Centre
Zhukovsky
Frunze Street, 1
Moscow
140180
Russian Federation
Study information
| Study design | International multicentre randomised double-blind parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | To compare the clinical acceptability of trimetazidine 80mg once daily with trimetazidine 35 mg twice daily |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 12/03/2012 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/03/2012 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Russian Federation
- Serbia
Study participating centre
Moscow Regional Cardiology Centre
Moscow
140180
Russian Federation
140180
Russian Federation
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Poster results | poster presentation | 27/08/2016 | No | No | |
| Results article | results | 01/06/2018 | Yes | No |
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.
