Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind
was performed in 30 male patients (50-60 years old) with Intermittent Claudication
(Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6
months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period
of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2
weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks
and 125 mg twice daily/eight weeks) or control group.