NCT01738542

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

CLAU Test Results (CLinical Assessment And Endothelin fUnction Assessment After Endothelin Receptor Antagonist) : Randomized Controlled Clinical Trial of Bosentan for Intermittent Claudication in Peripheral Arterial Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital Universitario Getafe · Academic / Other
• Sex: Male
• Age: 50 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Bosentan	Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
DRUG	Antiaggregant therapy	AAS 100mg/d or Clopidogrel 75mg/d
DRUG	Statins
DRUG	Antihypertensive therapy

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2012-11-30
• Last updated: 2012-11-30

Locations

1 site across 1 country: Spain