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 |
| Secondary identifying numbers | N0237109527 |
- 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
| Study design | Randomised double blind controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ramipiril, irbesartan |
| Primary outcome measure | 1. Vascular compliance 2. Blood pressure 3. 24 h protein excretion 4. Adverse events |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2002 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
Research Registrar
Prescot, Merseyside
L35 5DR
United Kingdom
L35 5DR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
St Helens and Knowsley Hospitals NHS Trust (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 |
