Russian observational program ODA

Not Applicable

Completed

• Conditions: Chronic coronary artery disease and stable angina; Circulatory System

• Registration Number: ISRCTN97780949
• Lead Sponsor: JSC Servier

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30105656 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30778909 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32430799/ results (added 26/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-29
• Study Completion: 2017-08-31
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3032

Inclusion Criteria

1. Confirmed diagnosis of Chronic Coronary Artery Disease and stable angina. Special care has to be taken that inclusion of patients into the non-interventional study is exclusively determined by the decision of the physician regarding medical meaningfulness and necessity of treatment with Preductal® OD 80 mg.
2. Signed informed consent
3. Aged 18 to 75 years old

Exclusion Criteria

1. Age over 75 years or under 18 years
2. Hypersensitivity to the active substance or to any of the excipients listed in Preductal® OD 80 mg SmPC
3. Parkinson disease, parkinsonian symptoms, tremors, restlessleg syndrome, and other related movement disorders
4. Severe renal impairment (creatinine clearance < 30ml/min)
5. Moderate renal impairment (creatinine clearance [30-60] ml/min)
6. Stable angina pectoris FC IV
7. Myocardial Infarction (MI) in the last 3 months before inclusion
8. Stroke/TIA in the last 3 months before inclusion
9. Uncontrolled HT (BP over 180/100 mm Hq) inspite of hypotensive therapy
10.Pregnancy or breastfeeding

Study & Design

• Study Type: Observational
• Study Design: Not specified