EUROPEAN GUIDANCE ON CLINICAL INVESTIGATIONS ON MEDICAL PRODUCTS FOR THE TREATMENT OF ANGINA

Based on the distinction between angina of effort and spontaneous angina these notes provide guidance on clinical investigations on Medical products for the treatment of the two types of angina separately. For angina of effort, the patients involved in clinical trials should be suffering from it stably over a period of at least a month. Studies with the use of placebo, comparative tests and exercise tests should be done for several weeks , six months and one year respectively. For spontaneous angina, patients most suitable for clinical investigations are those experiencing painful and/or painless ischaemia episodes recurring at least three times per day. Studies should be performed in a short term (some days), a medium term (some weeks to some months) and a long term. Placebo-controlled, double-blinded crossover test is the ideal design for the short-term study.