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

Diabetes, Type 2 Clinical Trial

— AFORRD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141232
• Other study ID #: A2581114
• Status: Completed
• Phase: Phase 4
• Start date: November 2004
• Est. completion date: July 2006

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Type 2

Intervention

Drug:
• Atorvastatin and Omega-3 fatty acids

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	Balham	London
United Kingdom	Pfizer Investigational Site	Bath	England
United Kingdom	Pfizer Investigational Site	Bath
United Kingdom	Pfizer Investigational Site	Bath
United Kingdom	Pfizer Investigational Site	Belfast
United Kingdom	Pfizer Investigational Site	Bexhill on Sea	East Sussex
United Kingdom	Pfizer Investigational Site	Bexhill-On-Sea	East Sussex
United Kingdom	Pfizer Investigational Site	Birmingham
United Kingdom	Pfizer Investigational Site	Bradford-on-Avon	Wiltshire
United Kingdom	Pfizer Investigational Site	Bucks
United Kingdom	Pfizer Investigational Site	Chesterfield
United Kingdom	Pfizer Investigational Site	Chippenham, Wiltshire
United Kingdom	Pfizer Investigational Site	Cookstown	Northern Ireland
United Kingdom	Pfizer Investigational Site	Cornwall
United Kingdom	Pfizer Investigational Site	County Antrim, Northern Ireland
United Kingdom	Pfizer Investigational Site	Crawley	West Sussex
United Kingdom	Pfizer Investigational Site	Darlington
United Kingdom	Pfizer Investigational Site	Darlington	County Durham
United Kingdom	Pfizer Investigational Site	Dronfield, Sheffield	England
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	East Sussex
United Kingdom	Pfizer Investigational Site	Farnworth	Bolton
United Kingdom	Pfizer Investigational Site	Fetcham	Surrey
United Kingdom	Pfizer Investigational Site	Fowey	Cornwall
United Kingdom	Pfizer Investigational Site	Frome	Somerset
United Kingdom	Pfizer Investigational Site	Fulham	London
United Kingdom	Pfizer Investigational Site	Halstead	Essex
United Kingdom	Pfizer Investigational Site	Hayes	Middlesex
United Kingdom	Pfizer Investigational Site	Hildenborough	Kent
United Kingdom	Pfizer Investigational Site	Irvine	Ayrshire
United Kingdom	Pfizer Investigational Site	Isle Of Wight
United Kingdom	Pfizer Investigational Site	Isle Of Wight
United Kingdom	Pfizer Investigational Site	Launceston	Cornwall
United Kingdom	Pfizer Investigational Site	Leeds	West Yorkshire
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Melksham	Wiltshire
United Kingdom	Pfizer Investigational Site	Newton Aycliffe	County Durham
United Kingdom	Pfizer Investigational Site	Penzance	Cornwall
United Kingdom	Pfizer Investigational Site	Penzance	Cornwall
United Kingdom	Pfizer Investigational Site	Plymouth	Devon
United Kingdom	Pfizer Investigational Site	Plymouth	Devon
United Kingdom	Pfizer Investigational Site	Saltash	Cornwall
United Kingdom	Pfizer Investigational Site	Sheffield	Yorkshire
United Kingdom	Pfizer Investigational Site	Southampton	Hampshire
United Kingdom	Pfizer Investigational Site	St Austell	Cornwall
United Kingdom	Pfizer Investigational Site	Stonehouse	Gloucestershire
United Kingdom	Pfizer Investigational Site	Surrey	England
United Kingdom	Pfizer Investigational Site	Swindon	Wiltshire
United Kingdom	Pfizer Investigational Site	Thorneton-Clevely	Lancashire
United Kingdom	Pfizer Investigational Site	Thornhill	Cardiff
United Kingdom	Pfizer Investigational Site	Three Bridges	Crawley
United Kingdom	Pfizer Investigational Site	Tooting	London
United Kingdom	Pfizer Investigational Site	Trowbridge	Wiltshire
United Kingdom	Pfizer Investigational Site	Warminster	Wiltshire
United Kingdom	Pfizer Investigational Site	Wellingborough	Northamptonshire
United Kingdom	Pfizer Investigational Site	Westbury
United Kingdom	Pfizer Investigational Site	Woking	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Churchill Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
Primary	LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:
Primary	Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)
Secondary	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.
Secondary	Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.

External Links

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