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

Hospital Universitario Getafe

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Drug: Antihypertensive therapy; Drug: Statins; Drug: Antiaggregant therapy; Drug: Bosentan

Study type: Interventional

Funder types: Other

Identifiers

NCT01738542

NTC25102012

E.C.13/2009.CEIC10 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Antiaggregants & Statins & Antihypertensives & Bosentan

Experimental group

Description:

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

Treatment:

Drug: Statins

Drug: Antiaggregant therapy

Drug: Bosentan

Drug: Antihypertensive therapy

Antiaggregants & Statins & Antihypertensives

Active Comparator group

Description:

Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy

Treatment:

Drug: Statins

Drug: Antiaggregant therapy

Drug: Antihypertensive therapy