[Double-blind randomized controlled trial of ifenprodil tartrate versus placebo in chronic arterial occlusive disease of the legs at stage II of the Leriche and Fontaine classification].

Authors report results on a comparative multicenter double blind trial carried out to assess the efficacy of Ifenprodil tartrate (*) (60 mg a.d.) versus placebo in symptomatic treatment of stable peripheral arterial occlusive disease (Fontaine stage II). Ninety four patients were included in this six months, two parallel group study (2 homogeneous groups) which shows a statistically significant functional improvement in the treatment group versus the placebo group. After six months of treatment, the maximum walking distance (MWD)--main assessment criteria--was 126.0 +/- 18.5 meters in the Ifenprodil group versus 46.4 +/- 20.2 meters in the placebo group (p = 0.005). This represents an improvement of 62.1% in the Ifenprodil group versus 21.0% in the placebo group. An improvement of at least 50% in MWD was observed in 41.3% of patients treated by Ifenprodil and in only 12.5% of patients receiving placebo (p = 0.002). The evolution of ankle/brachial systolic post exercise index from JO to J180 was not significantly different in the two groups. Clinical and biological tolerance of Ifenprodil tartrate was excellent.