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

NCT01738542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-11-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospital Universitario Getafe

    lead OTHER

Principal Investigators

  • De Haro Joaquin, MD, PhD · Hospital Universitario de Getafe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738542 on ClinicalTrials.gov