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

NCT ID: NCT01738542

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Keywords

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Bosentan Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

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

Antiaggregant therapy

Intervention Type DRUG

AAS 100mg/d or Clopidogrel 75mg/d

Statins

Intervention Type DRUG

Antihypertensive therapy

Intervention Type DRUG

Antiaggregants & Statins & Antihypertensives

Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy

Group Type ACTIVE_COMPARATOR

Antiaggregant therapy

Intervention Type DRUG

AAS 100mg/d or Clopidogrel 75mg/d

Statins

Intervention Type DRUG

Antihypertensive therapy

Intervention Type DRUG

Interventions

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Bosentan

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

Intervention Type DRUG

Antiaggregant therapy

AAS 100mg/d or Clopidogrel 75mg/d

Intervention Type DRUG

Statins

Intervention Type DRUG

Antihypertensive therapy

Intervention Type DRUG

Other Intervention Names

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Tracleer

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Getafe

OTHER

Sponsor Role lead

Responsible Party

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Joaquin de Haro, M.D.

Randomized controlled clinical trial of Bosentan in Intermittent Claudication in Peripheral Arterial Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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De Haro Joaquin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Getafe

Locations

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Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 26651453 (View on PubMed)

Other Identifiers

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E.C.13/2009.CEIC10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NTC25102012

Identifier Type: -

Identifier Source: org_study_id