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ISRCTN
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ISRCTN64783481
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ClinicalTrials.gov identifier
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Public title
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Fenofibrate Intervention and Event Lowering in Diabetes
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Scientific title
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Acronym
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FIELD
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Added as of 10/09/2007: The study has been approved by local ethics committees at each participating institution.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia, Finland, New Zealand
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Disease/condition/study domain
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Type 2 diabetes
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/1998
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Anticipated end date
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31/12/2005
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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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9,795
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Interventions
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200 mg daily comicronized fenofibrate or matching placebo.
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Primary outcome measure(s)
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First nonfatal myocardial infarction or coronary death.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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1. Fournier Pharma (France)
2. National Health and Medical Research Council (Australia)
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Trial website
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http://www.ctc.usyd.edu.au/trials/cardiovascular/field.htm
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Publications
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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
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Contact name
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Prof
Anthony
Keech
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Address
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NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77
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City/town
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Camperdown
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Zip/Postcode
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2040
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Country
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Australia
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Sponsor
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Australian National Health and Medical Research Council (NHMRC) Clinical Trials Centre
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Address
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Locked Bag 77
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City/town
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Camperdown NSW
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Zip/Postcode
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1450
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Country
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Australia
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Date applied
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27/09/2004
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Last edited
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18/01/2010
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Date ISRCTN assigned
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19/10/2004
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