Randomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD)
| ISRCTN | ISRCTN41194621 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41194621 |
| Protocol serial number | E185/124 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 30/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof TW Meade
Scientific
Scientific
Non-communicable Disease Epidemiology Unit
Department of Epidemiology and Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7927 2182 |
|---|---|
| tom.meade@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD) |
| Study acronym | LEADER trial |
| Study objectives | Bezafibrate reduces primary end point by 30%. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular |
| Intervention | Bezafibrate/control |
| Intervention type | Drug |
| Phase | |
| Drug / device / biological / vaccine name(s) | Bezafibrate |
| Primary outcome measure(s) |
Coronary heart disease events and strokes combined |
| Key secondary outcome measure(s) |
Fatal and non-fatal coronary events separately |
| Completion date | 30/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 1568 |
| Key inclusion criteria | Males with LEAD (no upper or lower age limit) |
| Key exclusion criteria | 1. Already on lipid-modifying agent 2. Renal or hepatic disease (including raised creatinine concentration) 3. Unstable angina; malignant disease 4. Serious intercurrent illness |
| Date of first enrolment | 01/05/1992 |
| Date of final enrolment | 30/09/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London School of Hygiene & Tropical Medicine
Non-communicable Disease Epidemiology Unit
London
WC1E 7HT
United Kingdom
London
WC1E 7HT
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 | design and intermediary results | 23/07/2001 | Yes | No | |
| Results article | results | 23/07/2001 | Yes | No | |
| Results article | results | 16/11/2002 | Yes | No | |
| Results article | results | 16/11/2002 | Yes | No |
Editorial Notes
HF 30/11/2017: internal review
