Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
CLAU
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
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 30, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedNovember 30, 2012
November 1, 2012
1.6 years
October 30, 2012
November 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (4)
Changes in Analytical plasma values at each visit respect baseline values
1 Year
Change in the ankle brachial index (ABI) respect baseline values
1 Year
Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values
1 Year
Occurrence of Adverse events during the study
1 Year
Other Outcomes (2)
Change in the serum levels of Endothelin (ET) respect baseline values
1 Year
Change in the serum levels of C-reactive protein (CRP) respect baseline values
1 Year
Study Arms (2)
Antiaggregants & Statins & Antihypertensives & Bosentan
EXPERIMENTALBosentan 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
Antiaggregants & Statins & Antihypertensives
ACTIVE COMPARATORAntiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy
Interventions
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
AAS 100mg/d or Clopidogrel 75mg/d
Eligibility Criteria
You may qualify if:
- Arterial hypertension and hypercholesterolemia
- ABI \<0,9
- Positive claudiometry with a claudication distance between 50 and 500
You may not qualify if:
- surgical patient
- Previous revascularization procedure in the Member studied
- Smoker
- Uncontrolled hypertension
- Cardiac Stress Test unfinished
- Prior DVT
- Concomitant severe disease
- Obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario de Getafe
Getafe, Madrid, 28901, Spain
Related Publications (1)
De Haro J, Bleda S, Varela C, Esparza L, Acin F; Bosentan Population-Based Randomized Trial for Clinical and Endothelial Function Assessment on Endothelin Antagonist Therapy in Patients With Intermittent Claudication CLAU Investigators. Effect of Bosentan on Claudication Distance and Endothelium-Dependent Vasodilation in Hispanic Patients With Peripheral Arterial Disease. Am J Cardiol. 2016 Jan 15;117(2):295-301. doi: 10.1016/j.amjcard.2015.10.032. Epub 2015 Nov 6.
PMID: 26651453DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
De Haro Joaquin, MD, PhD
Hospital Universitario de Getafe
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Randomized controlled clinical trial of Bosentan in Intermittent Claudication in Peripheral Arterial Disease
Study Record Dates
First Submitted
October 30, 2012
First Posted
November 30, 2012
Study Start
April 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
November 30, 2012
Record last verified: 2012-11