Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Getafe
• Treatments: Antihypertensive Agents; Bosentan; Clopidogrel; Endothelin Receptor Antagonists; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

Inclusion Criteria:

• Arterial hypertension and hypercholesterolemia

• ABI <0,9

• Positive claudiometry with a claudication distance between 50 and 500

Exclusion Criteria:

• surgical patient

• Previous revascularization procedure in the Member studied

• Smoker

• Uncontrolled hypertension

• Cardiac Stress Test unfinished

• Prior DVT

• Concomitant severe disease

• Obesity