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ISRCTN
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ISRCTN41194621
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DOI
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10.1186/ISRCTN41194621
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised controlled trial of bezafibrate in patients with lower extremity arterial disease (LEAD)
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Scientific title
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Acronym
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LEADER trial
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Serial number at source
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E185/124
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Study hypothesis
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Bezafibrate reduces primary end point by 30%.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular
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Participants - inclusion criteria
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Males with LEAD (no upper or lower age limit)
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Participants - exclusion criteria
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1. Already on lipid-modifying agent
2. Renal or hepatic disease (including raised creatinine concentration)
3. Unstable angina; malignant disease
4. Serious intercurrent illness
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Anticipated start date
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01/05/1992
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Anticipated end date
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30/09/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1568 men recruited through 85 practices in the Medical Research
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Interventions
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Bezafibrate/control
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Primary outcome measure(s)
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Coronary heart disease events and strokes combined
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Secondary outcome measure(s)
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Fatal and non-fatal coronary events separately
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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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.
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.
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Contact name
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Prof
TW
Meade
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Address
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Non-communicable Disease Epidemiology Unit
Department of Epidemiology and Population Health
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7927 2182
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Fax
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+44 (0)20 7580 6897
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Email
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tom.meade@lshtm.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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04/10/2007
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Date ISRCTN assigned
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06/04/2000
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