Tadalafil: effects on blood pressure and arterial stiffness in systolic hypertension
| ISRCTN | ISRCTN06158636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06158636 |
| Protocol serial number | N0544129338 |
| Sponsor | Department of Health |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tadalafil |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Clinical Pharmacology Unit
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
