Trental® 400 in the Treatment of Intermittent Claudication: Results of Long-Term, Placebo-Controlled Administration

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Abstract
A double-blind, randomized, placebo-controlled long-term clinical study of Trental® 400 was carried out, partly under cross-over design, partly as a parallel-group study, in 36 patients suffering from chronic arterial obstructive disorders in the lower limbs, associated with intermittent claudication, in order to evaluate the effectiveness and the safety of this drug administered t.i.d. over a period of 6 months. This controlled period was preceded by a placebo run-in period of 3 months. The clinical results under Trental 400 showed a statistically significant within group improvement of painfree and maximum walking parameters (p < 0.05) corresponding to an increase to baseline by + 96% to + 139% respectively and also in comparison to placebo (p < 0.05). The alterations of walking parameters within the placebo groups, ranging between -25% and +28% were not significant.