A study to examine the impact of blockade of the renin-angiotensin system on vascular compliance measurements in subjects with type 2 diabetes mellitus complicated by nephropathy
| ISRCTN | ISRCTN75257827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75257827 |
| Protocol serial number | N0237109527 |
| Sponsor | Department of Health (UK) |
| Funder | St Helens and Knowsley Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/09/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
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 Shirley Hulme
Scientific
Scientific
Research Registrar
St Helens & Knowsley Hospitals NHS Trust
Whiston Hospital
Prescot, Merseyside
L35 5DR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind controlled crossover group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The aims of this study are to examine the two null hypotheses stated below and, as a secondary measure, to evaluate the relationship between urinary protein excretion and vascular compliance. 1. There is no difference in the effect of ramipril or irbesartan on vascular compliance measurements in subjects with type 2 diabetes complicated with nephropathy 2. Combination therapy with ramipril and irbesartan does not confer any additional effect on vascular compliance when compared to each drug used in isolation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Vascular compliance |
| Intervention | Please not that as of 22/09/09 the status of this trial has been changed to "Stopped". The trial did not commence due to funding and resource issues Double blind randomised cross over design clinical trial. Subjects will be randomised to receive an angiotensin converting enzyme (ACE) inhibitor, ramipril plus placebo, or AT2 receptor antagonist, irbesartan plus placebo, or ramipril plus irbesartan for 6 weeks in maximum doses. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ramipiril, irbesartan |
| Primary outcome measure(s) |
1. Vascular compliance |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2004 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 42 |
| Key inclusion criteria | 42 Patients over 18 years of age. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Research Registrar
Prescot, Merseyside
L35 5DR
United Kingdom
L35 5DR
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 |
