Improving symptoms of intermittent claudication in patients with erectile dysfunction and peripheral vascular disease: a pilot study assessing the benefit of daily dosing with tadalafil (Cialis) 10mg. - PVD GJ001
Phase 1
- Conditions
- Peripheral vascular disease (PVD)MedDRA version: 14.0 Level: LLT Classification code 10034634 Term: Peripheral vascular disease NOS System Organ Class: 10047065 - Vascular disorders
- Registration Number
- EUCTR2006-005399-42-GB
- Lead Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
• Male aged 18-80 years with ED and Peripheral Vascular Disease
• Symptomatic claudication confirmed by previous ultrasound studies
• Provision of written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
• Contraindication to PDE-5 inhibitor
• Inability to undertake an exercise tolerance test (ETT).
• Patients taking nitrates
• Unable to provide written informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method