Contact information
Type
Scientific
Primary contact
Dr Ian B Wilkinson
ORCID ID
Contact details
Clinical Pharmacology Unit
Level 3
ACCI
Box 110
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 336806
ibw20@cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544129338
Study information
Scientific title
Acronym
Study hypothesis
Does the selective phosphodiesterase-5 inhibitor tadalafil reduce arterial stiffness and blood pressure in systolic hypertension?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hypertension
Intervention
The project will assess the effects of a single dose of the selective phosphodiesterase-5 inhibitor tadalafil on arterial stiffness and blood pressure in patients with systolic hypertension. Subjects will visit the Vascular Research Clinics for a screening visit and two study visits and will receive either placebo or tadalafil on each study visit. Measurements of blood pressure and arterial stiffness will be made at baseline and at hourly intervals for four hours following administration of the drug or placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Tadalafil
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/08/2003
Overall trial end date
10/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
15 subjects over 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
11/08/2003
Recruitment end date
10/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (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
Not published