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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joaquin de Haro, M.D., Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01738542
First received: October 30, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Drug: Bosentan
Drug: Antiaggregant therapy
Drug: Statins
Drug: Antihypertensive therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • Change in Absolute Claudication Distance (ACD) respect baseline values [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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


  • Change in flow-mediated arterial dilation (FMAD) respect baseline values [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Changes in Analytical plasma values at each visit respect baseline values [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

    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


  • Change in the ankle brachial index (ABI) respect baseline values [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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


  • 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 ] [ Designated as safety issue: No ]

    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


  • Occurrence of Adverse events during the study [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease.


Other Outcome Measures:
  • Change in the serum levels of Endothelin (ET) respect baseline values [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    To determine the efficacy of bosentan on the improvement in the endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease

  • Change in the serum levels of C-reactive protein (CRP) respect baseline values [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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



Enrollment: 30
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antiaggregants & Statins & Antihypertensives & Bosentan
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
Drug: Bosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
Other Name: Tracleer
Drug: Antiaggregant therapy
AAS 100mg/d or Clopidogrel 75mg/d
Drug: Statins Drug: Antihypertensive therapy
Active Comparator: Antiaggregants & Statins & Antihypertensives
Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy
Drug: Antiaggregant therapy
AAS 100mg/d or Clopidogrel 75mg/d
Drug: Statins Drug: Antihypertensive therapy

  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738542

Locations
Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28901
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
Principal Investigator: De Haro Joaquin, MD, PhD Hospital Universitario de Getafe
  More Information

No publications provided

Responsible Party: Joaquin de Haro, M.D., Randomized controlled clinical trial of Bosentan in Intermittent Claudication in Peripheral Arterial Disease, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01738542     History of Changes
Other Study ID Numbers: NTC25102012, E.C.13/2009.CEIC10
Study First Received: October 30, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital Universitario Getafe:
Bosentan
Peripheral Arterial Disease

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Bosentan
Antihypertensive Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 17, 2014