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

NCT00141232 | Completed Phase 4

• 1 other identifier: A2581114
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 59

Brief Summary

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?

Conditions

Diabetes, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

Interventions

Atorvastatin and Omega-3 fatty acids DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• They are taking prescribed lipid lowering therapy
• Have triglycerides \> or = 8.0 mmol/L

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead
• Churchill Hospital: collaborator

Study Sites (59)

Pfizer Investigational Site

Irvine, Ayrshire, KA12 OAY, United Kingdom

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Farnworth, Bolton, BL4 9AH, United Kingdom

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Thornhill, Cardiff, CF14 9BB, United Kingdom

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Fowey, Cornwall, PL23 1DT, United Kingdom

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Launceston, Cornwall, PL15 9HH, United Kingdom

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Penzance, Cornwall, TR18 4JH, United Kingdom

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Penzance, Cornwall, TR19 7HX, United Kingdom

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Saltash, Cornwall, PL12 6DL, United Kingdom

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St Austell, Cornwall, PL26 7RL, United Kingdom

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Darlington, County Durham, DL16 6QA, United Kingdom

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Newton Aycliffe, County Durham, DL5 5NH, United Kingdom

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Three Bridges, Crawley, RH10 1LL, United Kingdom

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Plymouth, Devon, PL5 3JB, United Kingdom

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Plymouth, Devon, PL6 7TH, United Kingdom

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Bexhill-on-Sea, East Sussex, TN39 4SP, United Kingdom

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Bexhill-on-Sea, East Sussex, TN40 2SD, United Kingdom

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Bath, England, BA2 4JT, United Kingdom

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Dronfield, Sheffield, England, S18 1RU, United Kingdom

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Surrey, England, CR7 7JN, United Kingdom

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Halstead, Essex, CO9 1EX, United Kingdom

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Stonehouse, Gloucestershire, GL10 2NG, United Kingdom

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Southampton, Hampshire, SO31 7DQ, United Kingdom

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Hildenborough, Kent, TN11 9HL, United Kingdom

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Thorneton-Clevely, Lancashire, FY5 3LF, United Kingdom

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Balham, London, SW12 8EU, United Kingdom

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Fulham, London, SW6 2HQ, United Kingdom

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Tooting, London, SW17 9SJ, United Kingdom

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Hayes, Middlesex, UB4 0SF, United Kingdom

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Wellingborough, Northamptonshire, NN8 4RW, United Kingdom

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Cookstown, Northern Ireland, BT80 8BN, United Kingdom

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Frome, Somerset, BA11 1EZ, United Kingdom

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Fetcham, Surrey, KT22 9LE, United Kingdom

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Woking, Surrey, United Kingdom

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Crawley, West Sussex, RH10 7DX, United Kingdom

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Leeds, West Yorkshire, LS12 1JE, United Kingdom

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Bradford-on-Avon, Wiltshire, BA1 5DQ, United Kingdom

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Melksham, Wiltshire, SN12 6UN, United Kingdom

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Swindon, Wiltshire, SN25 4YZ, United Kingdom

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Trowbridge, Wiltshire, BA14 7EG, United Kingdom

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Warminster, Wiltshire, BA12 9AA, United Kingdom

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Sheffield, Yorkshire, S7 2DW, United Kingdom

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Bath, BA2 1NH, United Kingdom

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Bath, BA2 3HT, United Kingdom

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Belfast, BT4 1NT, United Kingdom

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Birmingham, B37 7TR, United Kingdom

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Bucks, HP22 5LB, United Kingdom

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Chesterfield, S40 4TF, United Kingdom

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Chippenham, Wiltshire, SN15 2SB, United Kingdom

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Cornwall, TR18 2RE, United Kingdom

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County Antrim, Northern Ireland, BT41 3AE, United Kingdom

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Darlington, DL3 6HZ, United Kingdom

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Dundee, DD2 5NH, United Kingdom

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Dundee, DD4 6QY, United Kingdom

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East Sussex, TN40 3RJ, United Kingdom

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Isle of Wight, PO32 6RR, United Kingdom

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Isle of Wight, PO33 2PT, United Kingdom

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London, N19 5EW, United Kingdom

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London, SW19 6DA, United Kingdom

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Westbury, BA13 3JD, United Kingdom

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Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Atorvastatin; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fish Oils; Oils

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: November 1, 2004
• Study Completion: July 1, 2006
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

GB (59)