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Clinical Trials/ISRCTN97780949
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)

Registry
who.int
Start Date
May 29, 2017
End Date
August 31, 2017
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
JSC Servier

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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