| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN40898239 |
| Date ISRCTN assigned | 05/12/2007 |
| Local reference number(s) | GJ001 PVD |
| Public title | 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Erectile dysfunction, Peripheral Vascular Disease |
| Study hypothesis | 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. |
| Design/methodology | Prospective, randomised, double-blind, placebo controlled, cross over pilot study |
| Research ethics review | Ethics approval received from the St Thomas' Hospital Local Research Ethics Committee on the 9th January 2007 (ref: 06/Q0702/162). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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) |
| Participants - exclusion criteria | 1. Contraindication to PDE 5 inhibitor
2. Inability to undertake an exercise tolerance test |
| Patient information material |
|
| Anticipated start date | 19/09/2007 |
| Anticipated end date | 01/04/2008 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | 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. |
| Primary outcome measure(s) | 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. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | The Friend's of Guy's Hospital (UK) |
| Sponsor name | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Sponsor details | Research and Development Office
Floor 3, Coneybeare House
Guy's Hospital
St Thomas' Street
London
United Kingdom
SE1 9RT |
| Sponsor telephone | +44 (0)20 7188 5733 |
| Sponsor email | kate.blake@gstt.nhs.uk |
| Sponsor website | http://www.guysandstthomas.nhs.uk/ |
| Contact name | Dr Graham Jackson |
| Contact details | Cardiothoracic Centre
6th Floor, East Wing
St Thomas' Hospital
London
United Kingdom
SE1 7EH |
| Contact telephone | +44 (0)20 7188 1055 |
| Contact email | jean.stagg@gstt.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN40898239 |
| Date last extracted from ISRCTN register | 17/04/2008 |
