[Design and method of clinical trials of drugs used in the therapy of stable peripheral arterial occlusive disease].

To prove the efficacy of the treatment of atherosclerotic stable peripheral arterial occlusive disease with drugs certain criteria are to be considered in the context of the design and performance of clinical trials. These criteria refer to the design of the study, randomisation, blinding, inclusion and exclusion criteria, definition of outcomes, methods of examination, sample size estimation, and evaluation of the results. If these criteria and conditions are not taken into consideration, false positive and negative results can arise. In the present study, the criteria to prove the efficacy of vasoactive substances in the treatment of atherosclerotic peripheral occlusive arterial diseases are presented.