Condition category
Circulatory System
Date applied
18/09/2007
Date assigned
05/12/2007
Last edited
06/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Graham Jackson

ORCID ID

Contact details

Cardiothoracic Centre
6th Floor
East Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
+44 (0)20 7188 1055
jean.stagg@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GJ001 PVD

Study information

Scientific 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

Acronym

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.

Ethics approval

St Thomas' Hospital Local Research Ethics Committee, 09/01/2007, ref: 06/Q0702/162

Study design

Prospective randomised double-blind placebo-controlled cross-over pilot study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Erectile dysfunction, peripheral vascular disease

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tadalafil

Primary outcome measures

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 measures

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.

Overall trial start date

19/09/2007

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Contraindication to PDE 5 inhibitor
2. Inability to undertake an exercise tolerance test

Recruitment start date

19/09/2007

Recruitment end date

01/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

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
SE1 9RT
United Kingdom
+44 (0)20 7188 5733
kate.blake@gstt.nhs.uk

Sponsor type

Government

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Charity

Funder name

The Friend's of Guy's Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes