Contact information
Type
Scientific
Primary contact
Prof TW Meade
ORCID ID
Contact details
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
+44 (0)20 7927 2182
tom.meade@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
E185/124
Study information
Scientific title
Randomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD)
Acronym
LEADER trial
Study hypothesis
Bezafibrate reduces primary end point by 30%.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular
Intervention
Bezafibrate/control
Intervention type
Drug
Phase
Drug names
Bezafibrate
Primary outcome measures
Coronary heart disease events and strokes combined
Secondary outcome measures
Fatal and non-fatal coronary events separately
Overall trial start date
01/05/1992
Overall trial end date
30/09/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Males with LEAD (no upper or lower age limit)
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
1568 men recruited through 85 practices
Participant 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
Recruitment start date
01/05/1992
Recruitment end date
30/09/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London School of Hygiene & Tropical Medicine
Non-communicable Disease Epidemiology Unit
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2001 design and intermediary results in https://www.ncbi.nlm.nih.gov/pubmed/11806795
T.W. Meade for the British Medical Council General Practive Research Framework and participating vascular clinics. Design and intermediate results of the Lower Extremity Arterial Disease Event Reduction (LEADER) trial of bezafibrate in men with lower extremity arterial disease. [ISRCTN4119421] Curr Control Trials Cardiovasc Med, 2001;2:195-204.
2. 2002 results in https://www.ncbi.nlm.nih.gov/pubmed/12433762
T.W. Meade, R. Zuhrie, C. Cook, J. Cooper. Bezafibrate in men with lower extremity arterial disease: randomised controlled trial. [ISRCTN4119421] BMJ, 2002;325:1139-1141.