Multi-centre randomised double blind parallel group study: enalapril vs nifedipine vs placebo in diabetic patients
| ISRCTN | ISRCTN01207964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01207964 |
| Protocol serial number | 0010 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof R Bilous
Scientific
Scientific
South Cleveland Hospital
Audrey Collins Teaching Unit
Education Centre
Marton Road
Middlesborough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 854 146 |
|---|---|
| r.w.bilous@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled double-blind parallel group study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Multi-centre randomised double blind parallel group study: enalapril vs nifedipine vs placebo in diabetic patients |
| Study acronym | ESPRIT |
| Study objectives | A multi-centre randomised double blind parallel group study evaluating the efficacy of Enalapril and Nifedipine retard and placebo on the evolution of the renal glomerular lesions of diabetic patients with increased urinary albumin excretion. To determine whether Enalapril (an ACE inhibitor) preferentially halts or reverses the progression of the glomerular lesions of diabetic nephropathy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, metabolic and endocrine diseases: Diabetes |
| Intervention | Enalapril and nifedipine retard versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Enalapril and Nifedipine retard |
| Primary outcome measure(s) |
Whether Enalapril (an ACE inhibitor) preferentially halts or reverses the progression of the glomerular lesions of diabetic nephropathy. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | Diabetic patients with increased urinary albumin excretion |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 04/01/1993 |
| Date of final enrolment | 31/03/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
South Cleveland Hospital
Middlesborough
TS4 3BW
United Kingdom
TS4 3BW
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? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2001 | 24/10/2019 | Yes | No |
| Other publications | ESPRIT publications | 01/02/2000 | Yes | No |
Editorial Notes
24/10/2019: Publication reference added.
