Randomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD)

ISRCTN ISRCTN41194621
DOI https://doi.org/10.1186/ISRCTN41194621
Secondary identifying numbers E185/124
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

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
Email tom.meade@lshtm.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRandomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD)
Study acronymLEADER trial
Study objectivesBezafibrate reduces primary end point by 30%.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular
InterventionBezafibrate/control
Intervention typeDrug
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)Bezafibrate
Primary outcome measureCoronary heart disease events and strokes combined
Secondary outcome measuresFatal and non-fatal coronary events separately
Overall study start date01/05/1992
Completion date30/09/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexMale
Target number of participants1568 men recruited through 85 practices
Key inclusion criteriaMales with LEAD (no upper or lower age limit)
Key exclusion criteria1. 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 enrolment01/05/1992
Date of final enrolment30/09/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

London School of Hygiene & Tropical Medicine
Non-communicable Disease Epidemiology Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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