ISRCTN97780949
Completed
未知
Evaluation of effectiveness and therapeutic response to Preductal OD 80 mg in daily practical use for chronic stable angina pectoris
JSC Servier0 sites3,032 target enrollmentMay 29, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- JSC Servier
- Enrollment
- 3032
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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