Condition category
Circulatory System
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
04/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Not Specified

Patient information sheet

Condition

Cardiovascular

Intervention

Bezafibrate/control

Intervention type

Other

Phase

Not Specified

Drug names

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 in the Medical Research

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

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.

Publication citations

Additional files

Editorial Notes