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临床试验/ISRCTN97780949
ISRCTN97780949已完成未知

Evaluation of effectiveness and therapeutic response to Preductal OD 80 mg in daily practical use for chronic stable angina pectoris

JSC Servier0 个研究点目标入组 3,032 人开始时间: 2017年5月29日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
3,032

研究概览

简要总结

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)

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
JSC Servier

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