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ISRCTN
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ISRCTN40898239
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ClinicalTrials.gov identifier
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Public title
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Improving symptoms of intermittent claudication in patients with erectile dysfunction and peripheral vascular disease: a pilot study assessing the benefit of daily dosing with Cialis (tadalafil) 10 mg
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Scientific title
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Acronym
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N/A
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Serial number at source
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GJ001 PVD
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Study hypothesis
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Daily dosing with the Phosphodiesterase type 5 (PDE 5) inhibitor tadalafil (10 mg) (for a 14-day period) may improve symptoms of claudication in patients with erectile dysfunction and peripheral vascular disease.
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Ethics approval
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Ethics approval received from the St Thomas' Hospital Local Research Ethics Committee on the 9th January 2007 (ref: 06/Q0702/162).
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Study design
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Prospective, randomised, double-blind, placebo controlled, cross over pilot study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Erectile dysfunction, Peripheral Vascular Disease
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Participants - inclusion criteria
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1. Male aged 40 - 80 years
2. Erectile dysfunction (Sexual Health Inventory for Men [SHIM] score less than 21)
3. Peripheral Vascular Disease (PVD) (confirmed by previous ultrasound studies)
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Participants - exclusion criteria
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1. Contraindication to PDE 5 inhibitor
2. Inability to undertake an exercise tolerance test
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Anticipated start date
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19/09/2007
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Anticipated end date
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01/04/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Suitably screened and consenting patients will undertake an Exercise Tolerance Test (ETT) (modified Bruce protocol). Once baseline is established (two tests, 2 weeks apart), Tadalafil 10 mg daily or placebo will be prescribed for a 14 day period. ETT will then be repeated. A weeks wash-out will be observed. A repeat ETT will be undertaken and the patient prescribed either placebo or tadalafil for a further 14 day period. ETT will be repeated. A final follow up occurs one week after this, and with a one week run in, this makes the total duration of this study 7 weeks.
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Primary outcome measure(s)
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Total number of minutes/seconds on the exercise treadmill. Time to first report of leg pain will be recorded, measured at the end of weeks 3, 4 and 6.
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Secondary outcome measure(s)
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Change in score on the Walking Impairment Questionnaire and the Peripheral Artery Disease Symptom Scale, measured at the end of weeks 3, 4 and 6.
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Sources of funding
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The Friend's of Guy's Hospital (UK)
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Trial website
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Publications
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Contact name
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Dr
Graham
Jackson
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Address
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Cardiothoracic Centre
6th Floor, East Wing
St Thomas' Hospital
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 1055
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Email
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jean.stagg@gstt.nhs.uk
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Sponsor
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Guy's and St Thomas' NHS Foundation Trust (UK)
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Address
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Research and Development Office
Floor 3, Coneybeare House
Guy's Hospital
St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 5733
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Email
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kate.blake@gstt.nhs.uk
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Sponsor website:
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http://www.guysandstthomas.nhs.uk/
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Date applied
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18/09/2007
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Last edited
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05/12/2007
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Date ISRCTN assigned
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05/12/2007
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