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ISRCTN
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ISRCTN76737502
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DOI
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10.1186/ISRCTN76737502
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ClinicalTrials.gov identifier
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NCT00141232
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EudraCT number
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Public title
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Atorvastatin in Factorial with Omega-3 fatty acid Risk Reduction in Diabetes
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Scientific title
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Acronym
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AFORRD
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Serial number at source
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A2581114
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Not provided at time of registration
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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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Type 2 Diabetes
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Participants - inclusion criteria
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Aged 18 years or above; have had Type 2 Diabetes for at least 3 months; not known to have had a cardiovascular event; have provided written informed consent; in UK general practice.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/2004
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Anticipated end date
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31/07/2006
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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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1000 patients in 70 UK clinical centres
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Interventions
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Placebo-controlled double-blind, 2 x 2 factorial randomisation - it is a one year treatment trial of 1000 participants, 250 randomised to each receive either:
1. Atorvastatin (Lipitor 20mg/day) and comparator (olive oil) (250 participants)
2. Omega-3 polyunsaturated fatty acids (PUFA) (Omacor 2g/day) and placebo (250 participants)
3. Atorvastatin and Omega-3 PUFA (250 participants)
4. Placebo and comparator (olive oil) (250 participants)
In addition, according to their cardiovascular disease (CVD) risk which is assessed at the start of the trial, all participants at greater than or equal to 20% 10-year CVD risk will be allocated (single blind) to the Atorvastatin treatment arm of the study at 16 weeks. If already in the treatment arm, their dose of Atorvastatin will be doubled.
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Primary outcome measure(s)
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Not provided at time of registration
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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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Pfizer Ltd
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Trial website
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Publications
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1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19002433
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21036355
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Contact name
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Prof
Rury R
Holman
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Address
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Diabetes Trials Unit
Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM)
Churchill Hospital
Old Road
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Sponsor
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Pfizer Ltd
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Address
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IPC 2F, Walton Oaks
Dorking Road
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City/town
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Tadworth
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Zip/Postcode
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KT20 7NS
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Country
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United Kingdom
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Date applied
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04/08/2004
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Last edited
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30/10/2012
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Date ISRCTN assigned
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14/09/2004
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