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

Peripheral Arterial Disease Clinical Trial

— CLAU  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738542
• Other study ID #: NTC25102012
• Secondary ID: E.C.13/2009.CEIC
• Status: Completed
• Phase: N/A
• First received: October 30, 2012
• Last updated: November 28, 2012
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2012
• Source: Hospital Universitario Getafe
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Bosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
• Antiaggregant therapy
AAS 100mg/d or Clopidogrel 75mg/d
• Statins

• Antihypertensive therapy

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the serum levels of Endothelin (ET) respect baseline values	To determine the efficacy of bosentan on the improvement in the endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease	1 Year	No
Other	Change in the serum levels of C-reactive protein (CRP) respect baseline values	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	1 Year	No
Primary	Change in Absolute Claudication Distance (ACD) respect baseline values	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	1 Year	No
Primary	Change in flow-mediated arterial dilation (FMAD) respect baseline values	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	1 Year	No
Secondary	Changes in Analytical plasma values at each visit respect baseline values	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	1 Year	Yes
Secondary	Change in the ankle brachial index (ABI) respect baseline values	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	1 Year	No
Secondary	Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values	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	1 Year	No
Secondary	Occurrence of Adverse events during the study	Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease.	1 Year	Yes