Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Atorvastatin and Omega-3 fatty acids (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

The AFORRD trial is asking three important questions: What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?

Official title: A Multicentre, Randomised, Double Blind Placebo Controlled Trial Evaluating Atorvastatin in Factorial With Omega-3 Fatty Acids Cardiovascular Risk Reduction in Patients With Type 2 Diabetes: Protocol ID: A2581114 Regulatory Authority Number: 16051/004/A

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Primary outcome:

Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured

LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:

Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)

Secondary outcome:

Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16.

Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry. Are not known to have had a cardiovascular event Exclusion Criteria: They are taking prescribed lipid lowering therapy Have triglycerides > or = 8. 0 mmol/L

Pfizer Investigational Site, Bath BA2 3HT, United Kingdom

Pfizer Investigational Site, Bath BA2 1NH, United Kingdom

Pfizer Investigational Site, Westbury BA13 3JD, United Kingdom

Pfizer Investigational Site, Chippenham, Wiltshire SN15 2SB, United Kingdom

Pfizer Investigational Site, Birmingham B37 7TR, United Kingdom

Pfizer Investigational Site, Chesterfield S40 4TF, United Kingdom

Pfizer Investigational Site, Bucks HP22 5LB, United Kingdom

Pfizer Investigational Site, Dundee DD2 5NH, United Kingdom

Pfizer Investigational Site, London N19 5EW, United Kingdom

Pfizer Investigational Site, Dundee DD4 6QY, United Kingdom

Pfizer Investigational Site, Cornwall TR18 2RE, United Kingdom

Pfizer Investigational Site, London SW19 6DA, United Kingdom

Pfizer Investigational Site, East Sussex TN40 3RJ, United Kingdom

Pfizer Investigational Site, County Antrim, Northern Ireland BT41 3AE, United Kingdom

Pfizer Investigational Site, Darlington DL3 6HZ, United Kingdom

Pfizer Investigational Site, Belfast BT4 1NT, United Kingdom

Pfizer Investigational Site, Isle of Wight PO33 2PT, United Kingdom

Pfizer Investigational Site, Isle of Wight PO32 6RR, United Kingdom

Pfizer Investigational Site, Irvine, Ayrshire KA12 OAY, United Kingdom

Pfizer Investigational Site, Farnworth, Bolton BL4 9AH, United Kingdom

Pfizer Investigational Site, Penzance, CORNWALL TR18 4JH, United Kingdom

Pfizer Investigational Site, Saltash, CORNWALL PL12 6DL, United Kingdom

Pfizer Investigational Site, Thornhill, Cardiff CF14 9BB, United Kingdom

Pfizer Investigational Site, Fowey, Cornwall PL23 1DT, United Kingdom

Pfizer Investigational Site, Penzance, Cornwall TR19 7HX, United Kingdom

Pfizer Investigational Site, Launceston, Cornwall PL15 9HH, United Kingdom

Pfizer Investigational Site, St Austell, Cornwall PL26 7RL, United Kingdom

Pfizer Investigational Site, Darlington, County Durham DL16 6QA, United Kingdom

Pfizer Investigational Site, Newton Aycliffe, County Durham DL5 5NH, United Kingdom

Pfizer Investigational Site, Three Bridges, Crawley RH10 1LL, United Kingdom

Pfizer Investigational Site, Plymouth, Devon PL6 7TH, United Kingdom

Pfizer Investigational Site, Plymouth, Devon PL5 3JB, United Kingdom

Pfizer Investigational Site, Bath, ENGLAND BA2 4JT, United Kingdom

Pfizer Investigational Site, Surrey, ENGLAND CR7 7JN, United Kingdom

Pfizer Investigational Site, Dronfield, Sheffield, ENGLAND S18 1RU, United Kingdom

Pfizer Investigational Site, Bexhill-On-Sea, East Sussex TN40 2SD, United Kingdom

Pfizer Investigational Site, Bexhill on Sea, East Sussex TN39 4SP, United Kingdom

Pfizer Investigational Site, Halstead, Essex CO9 1EX, United Kingdom

Pfizer Investigational Site, Stonehouse, Gloucestershire GL10 2NG, United Kingdom

Pfizer Investigational Site, Southampton, Hampshire SO31 7DQ, United Kingdom

Pfizer Investigational Site, Hildenborough, Kent TN11 9HL, United Kingdom

Pfizer Investigational Site, Thorneton-Clevely, Lancashire FY5 3LF, United Kingdom

Pfizer Investigational Site, Tooting, London SW17 9SJ, United Kingdom

Pfizer Investigational Site, Balham, London SW12 8EU, United Kingdom

Pfizer Investigational Site, Fulham, London SW6 2HQ, United Kingdom

Pfizer Investigational Site, Hayes, Middlesex UB4 0SF, United Kingdom

Pfizer Investigational Site, Wellingborough, Northamptonshire NN8 4RW, United Kingdom

Pfizer Investigational Site, Cookstown, Northern Ireland BT80 8BN, United Kingdom

Pfizer Investigational Site, Frome, SOMERSET BA11 1EZ, United Kingdom

Pfizer Investigational Site, Woking, Surrey, United Kingdom

Pfizer Investigational Site, Fetcham, Surrey KT22 9LE, United Kingdom

Pfizer Investigational Site, Warminster, WILTSHIRE BA12 9AA, United Kingdom

Pfizer Investigational Site, Melksham, WILTSHIRE SN12 6UN, United Kingdom

Pfizer Investigational Site, Crawley, West Sussex RH10 7DX, United Kingdom

Pfizer Investigational Site, Leeds, West Yorkshire LS12 1JE, United Kingdom

Pfizer Investigational Site, Bradford-on-Avon, Wiltshire BA1 5DQ, United Kingdom

Pfizer Investigational Site, Trowbridge, Wiltshire BA14 7EG, United Kingdom

Pfizer Investigational Site, Swindon, Wiltshire SN25 4YZ, United Kingdom

Pfizer Investigational Site, Sheffield, YORKSHIRE S7 2DW, United Kingdom

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting:

Starting date: November 2004
Ending date: July 2006
Last updated: June 7, 2007