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 |
| Secondary identifying numbers | 0010 |
- 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
| Study design | Multicentre randomised controlled double-blind parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Enalapril and Nifedipine retard |
| Primary outcome measure | Whether Enalapril (an ACE inhibitor) preferentially halts or reverses the progression of the glomerular lesions of diabetic nephropathy. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 04/01/1993 |
| Completion date | 31/03/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
South Cleveland Hospital
Middlesborough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | ESPRIT publications | 01/02/2000 | Yes | No | |
| Results article | results | 01/04/2001 | 24/10/2019 | Yes | No |
Editorial Notes
24/10/2019: Publication reference added.
