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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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18 June 2018 |
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Main ID: |
ISRCTN84362208 |
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Date of registration:
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04/04/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical acceptability of trimetazidine 80 mg once daily compared to trimetazidine 35 mg twice daily in patients with chronic stable angina pectoris
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Scientific title:
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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 |
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Date of first enrolment:
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12/03/2012 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN84362208 |
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Study type:
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Interventional |
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Study design:
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International multicentre randomised double-blind parallel-group study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Russian Federation
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Serbia
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Contacts
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Name:
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Yuri M
Pozdnyakov |
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Address:
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Moscow Regional Cardiology Centre
Zhukovsky
Frunze Street, 1
140180
Moscow
Russian Federation |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Angina pectoris attacks
Circulatory System
Angina pectoris
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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No secondary outcome measures
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Secondary ID(s)
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CL3-06795-008
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval was obtained before recruitment of the first participants
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2012 |
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URL:
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