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Fenofibrate Intervention and Event Lowering in Diabetes
ISRCTN ISRCTN64783481
DOI 10.1186/ISRCTN64783481
ClinicalTrials.gov identifier
EudraCT number
Public title Fenofibrate Intervention and Event Lowering in Diabetes
Scientific title
Acronym FIELD
Serial number at source N/A
Study hypothesis The trial aims to determine whether treatment with fenofibrate, a potent modifier of blood lipid levels, will reduce the risk of fatal coronary heart disease in people with type 2 diabetes.
Lay summary Not provided at time of registration
Ethics approval Added as of 10/09/2007: The study has been approved by local ethics committees at each participating institution.
Study design Randomised controlled trial
Countries of recruitment Australia, Finland, New Zealand
Disease/condition/study domain Type 2 diabetes
Participants - inclusion criteria 1. Type 2 diabetes mellitus with onset after the age of 35 years
2. Men and women aged 50-75 years of age
3. Average total cholesterol 3.0-6.5 mmol/L
4. Triglycerides/high-density cholesterol ratio of 4.0 or higher, or triglycerides over 1.0 mmol/L
Participants - exclusion criteria Added as of 21/04/2008:
1. Triglyceride levels over 5.0 mmol/L
2. Participants could not be taking any lipid-modifying therapy at the start of the dietary run-in period. However, the protocol allows for statin or other lipid-lowering therapy to be added at any time after randomisation and recommends continuing study medication
Anticipated start date 01/01/1998
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 9,795
Interventions 200 mg daily comicronized fenofibrate or matching placebo.
Primary outcome measure(s) First nonfatal myocardial infarction or coronary death.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding 1. Fournier Pharma (France)
2. National Health and Medical Research Council (Australia)
Trial website http://www.ctc.usyd.edu.au/trials/cardiovascular/field.htm
Publications 1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15571637
2. 2005 results on baseline characteristics and short-term effects of fenofibrate in http://www.ncbi.nlm.nih.gov/pubmed/16111499
3. 2005 results on long term effects of fenofibrate in http://www.ncbi.nlm.nih.gov/pubmed/16310551
4. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17988728
5. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20072614
6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21052978
7. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22424024
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22210576
Contact name Prof  Anthony  Keech
  Address NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
  City/town Camperdown
  Zip/Postcode 2040
  Country Australia
Sponsor Australian National Health and Medical Research Council (NHMRC) Clinical Trials Centre
  Address Locked Bag 77
  City/town Camperdown NSW
  Zip/Postcode 1450
  Country Australia
Date applied 27/09/2004
Last edited 14/06/2012
Date ISRCTN assigned 19/10/2004
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