Tadalafil: effects on blood pressure and arterial stiffness in systolic hypertension
| ISRCTN | ISRCTN06158636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06158636 |
| Secondary identifying numbers | N0544129338 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian B Wilkinson
Scientific
Scientific
Clinical Pharmacology Unit
Level 3, ACCI
Box 110
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 336806 |
|---|---|
| ibw20@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Does the selective phosphodiesterase-5 inhibitor tadalafil reduce arterial stiffness and blood pressure in systolic hypertension? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tadalafil |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 11/08/2003 |
| Completion date | 10/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Key inclusion criteria | 15 subjects over 18 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 11/08/2003 |
| Date of final enrolment | 10/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
