Skip to main content
OpenTrials
Completed

NCT Number: NCT01738542

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Getafe

Getafe, Madrid, 28901, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)

Other names: Tracleer

Antiaggregant therapy

Drug

AAS 100mg/d or Clopidogrel 75mg/d

Statins

Drug

Antihypertensive therapy

Drug

Primary outcomes

  1. Change in Absolute Claudication Distance (ACD) respect baseline values

    Time frame: 1 Year

    To determine the efficacy of bosentan on the improvement in the absolute claudication distance in the exercise in patients with Intermittent Claudication due Peripheral Arterial Disease.

    ACD and percentage of change, both for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

  2. Change in flow-mediated arterial dilation (FMAD) respect baseline values

    Time frame: 1 Year

    To determine the efficacy of bosentan on the improvement in the overall endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease

    FMAD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

Secondary outcomes

  1. Changes in Analytical plasma values at each visit respect baseline values

    Time frame: 1 Year

    Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease.

    Analytical values : plasma electrolyte values, hepatic function, renal function, coagulation profiles, peripheral blood cell count

  2. Change in the ankle brachial index (ABI) respect baseline values

    Time frame: 1 Year

    Efficacy of bosentan on the improvement in the hemodynamic states in patients with Intermittent Claudication due Peripheral Arterial Disease.

    ABI for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

  3. Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values

    Time frame: 1 Year

    Efficacy of bosentan on the improvement of functional status (symptoms of claudication) in patients with Intermittent Claudication due Peripheral Arterial Disease

    SCD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

  4. Occurrence of Adverse events during the study

    Time frame: 1 Year

    Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease.

Other outcomes

  1. Change in the serum levels of Endothelin (ET) respect baseline values

    Time frame: 1 Year

    To determine the efficacy of bosentan on the improvement in the endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease

  2. Change in the serum levels of C-reactive protein (CRP) respect baseline values

    Time frame: 1 Year

    To determine the efficacy of bosentan on the improvement in inflammatory status in patients with Intermittent Claudication due Peripheral Arterial Disease.

    CRP for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Official study title

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

Acronym: CLAU

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 30, 2012
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.