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

NCT ID: NCT00141232

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-07-31

Brief Summary

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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?

Detailed Description

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Conditions

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Diabetes, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin and Omega-3 fatty acids

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Churchill Hospital

OTHER

Sponsor Role collaborator

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Irvine, Ayrshire, United Kingdom

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Farnworth, Bolton, United Kingdom

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Thornhill, Cardiff, United Kingdom

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Fowey, Cornwall, United Kingdom

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Launceston, Cornwall, United Kingdom

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Penzance, Cornwall, United Kingdom

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Penzance, Cornwall, United Kingdom

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Saltash, Cornwall, United Kingdom

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St Austell, Cornwall, United Kingdom

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Darlington, County Durham, United Kingdom

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Newton Aycliffe, County Durham, United Kingdom

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Three Bridges, Crawley, United Kingdom

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Plymouth, Devon, United Kingdom

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Plymouth, Devon, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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Bath, England, United Kingdom

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Dronfield, Sheffield, England, United Kingdom

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Surrey, England, United Kingdom

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Halstead, Essex, United Kingdom

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Stonehouse, Gloucestershire, United Kingdom

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Southampton, Hampshire, United Kingdom

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Hildenborough, Kent, United Kingdom

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Thorneton-Clevely, Lancashire, United Kingdom

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Balham, London, United Kingdom

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Fulham, London, United Kingdom

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Tooting, London, United Kingdom

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Hayes, Middlesex, United Kingdom

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Wellingborough, Northamptonshire, United Kingdom

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Cookstown, Northern Ireland, United Kingdom

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Frome, Somerset, United Kingdom

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Fetcham, Surrey, United Kingdom

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Woking, Surrey, United Kingdom

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Crawley, West Sussex, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Bradford-on-Avon, Wiltshire, United Kingdom

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Melksham, Wiltshire, United Kingdom

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Swindon, Wiltshire, United Kingdom

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Trowbridge, Wiltshire, United Kingdom

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Warminster, Wiltshire, United Kingdom

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Sheffield, Yorkshire, United Kingdom

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Bath, , United Kingdom

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Bath, , United Kingdom

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Bucks, , United Kingdom

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Chesterfield, , United Kingdom

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Chippenham, Wiltshire, , United Kingdom

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Cornwall, , United Kingdom

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County Antrim, Northern Ireland, , United Kingdom

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Darlington, , United Kingdom

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Dundee, , United Kingdom

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Dundee, , United Kingdom

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East Sussex, , United Kingdom

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Isle of Wight, , United Kingdom

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Isle of Wight, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Westbury, , United Kingdom

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Countries

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United Kingdom

Related Links

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Other Identifiers

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A2581114

Identifier Type: -

Identifier Source: org_study_id

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