Peripheral Arterial DiseaseCLAUNCT01738542
Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
A study testing Bosentan, Antiaggregant therapy and Statins in people with Peripheral Arterial Disease, run by Hospital Universitario Getafe at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Bosentan, Antiaggregant therapy and Statins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Arterial hypertension and hypercholesterolemia
- ABI <0,9
- Positive claudiometry with a claudication distance between 50 and 500
Who cannot join
- surgical patient
- Previous revascularization procedure in the Member studied
- Smoker
- Uncontrolled hypertension
- Cardiac Stress Test unfinished
- Prior DVT
- Concomitant severe disease
- Obesity
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Bosentan, Antiaggregant therapy, Statins, Antihypertensive therapy
- Keywords
- Bosentan, Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Also called Tracleer
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
Antiaggregant therapyDrug
AAS 100mg/d or Clopidogrel 75mg/d
StatinsDrug
Antihypertensive therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Antiaggregants & Statins & Antihypertensives & Bosentan | Experimental | 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 Receives: Drug: Bosentan; Drug: Antiaggregant therapy; Drug: Statins; Drug: Antihypertensive therapy |
| Antiaggregants & Statins & Antihypertensives | Active comparator | Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy Receives: Drug: Antiaggregant therapy; Drug: Statins; Drug: Antihypertensive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 Year
Secondary outcomes (4)
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
Measured: 1 Year
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
Measured: 1 Year
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
Measured: 1 Year
Occurrence of Adverse events during the study
Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin de Haro, M.D., Hospital Universitario Getafe
- Investigators
- De Haro Joaquin, MD, PhD, Principal investigator, Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738542
- Sponsor's protocol ID
- NTC25102012
- Other IDs
- E.C.13/2009.CEIC10
- Acronym
- CLAU
- Status last verified
- Nov 2012
- First submitted
- 30 Oct 2012
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26651453
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01738542
- Acronym / sponsor ID
- CLAU / NTC25102012
- Conditions
- Peripheral Arterial Disease
- Keywords
- Bosentan, Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiaggregants & Statins & Antihypertensives & Bosentan | Experimental | Drug: Bosentan, Drug: Antiaggregant therapy, Drug: Statins, Drug: Antihypertensive therapyBosentan 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 comparator | Drug: Antiaggregant therapy, Drug: Statins, Drug: Antihypertensive therapyAntiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Arterial hypertension and hypercholesterolemia
- ABI <0,9
- Positive claudiometry with a claudication distance between 50 and 500
Key exclusion criteria (8 listed)
- surgical patient
- Previous revascularization procedure in the Member studied
- Smoker
- Uncontrolled hypertension
- Cardiac Stress Test unfinished
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosentanAlso: TracleerBosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) | Drug | Antiaggregants & Statins & Antihypertensives & Bosentan |
| Antiaggregant therapyAAS 100mg/d or Clopidogrel 75mg/d | Drug | Antiaggregants & Statins & Antihypertensives, Antiaggregants & Statins & Antihypertensives & Bosentan |
| Statins | Drug | Antiaggregants & Statins & Antihypertensives, Antiaggregants & Statins & Antihypertensives & Bosentan |
| Antihypertensive therapy | Drug | Antiaggregants & Statins & Antihypertensives, Antiaggregants & Statins & Antihypertensives & Bosentan |
Primary outcome
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
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
4 secondary outcomes
Changes in Analytical plasma values at each visit respect baseline values
Time frame: 1 Year
Change in the ankle brachial index (ABI) respect baseline values
Time frame: 1 Year
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
Occurrence of Adverse events during the study
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Derived from this study: PubMed 26651453De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
De Haro Joaquin, MD, PhD principal investigator
Hospital Universitario de Getafe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bosentan, Antiaggregant therapy and Statins in people with Peripheral Arterial Disease, run by Hospital Universitario Getafe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Absolute Claudication Distance (ACD) respect baseline values (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.