Clinical trial NCT00141232: Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes, Type 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Churchill Hospital
First posted: 2005-09-01
Enrollment: 810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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?


Eligibility 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

Primary outcomes:
measure: Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured
measure: LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid:
measure: Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl)
Secondary outcomes:
measure: 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.
measure: Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks.
Other outcomes:
Locations:
city: Irvine
country: United Kingdom
facility: Pfizer Investigational Site
state: Ayrshire
city: Farnworth
country: United Kingdom
facility: Pfizer Investigational Site
state: Bolton
city: Thornhill
country: United Kingdom
facility: Pfizer Investigational Site
state: Cardiff
city: Fowey
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Launceston
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Penzance
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Penzance
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Saltash
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: St Austell
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Darlington
country: United Kingdom
facility: Pfizer Investigational Site
state: County Durham
city: Newton Aycliffe
country: United Kingdom
facility: Pfizer Investigational Site
state: County Durham
city: Three Bridges
country: United Kingdom
facility: Pfizer Investigational Site
state: Crawley
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Devon
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Bexhill-On-Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Dronfield, Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Surrey
country: United Kingdom
facility: Pfizer Investigational Site
state: England
city: Halstead
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: Stonehouse
country: United Kingdom
facility: Pfizer Investigational Site
state: Gloucestershire
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Hildenborough
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Thorneton-Clevely
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Balham
country: United Kingdom
facility: Pfizer Investigational Site
state: London
city: Fulham
country: United Kingdom
facility: Pfizer Investigational Site
state: London
city: Tooting
country: United Kingdom
facility: Pfizer Investigational Site
state: London
city: Hayes
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Wellingborough
country: United Kingdom
facility: Pfizer Investigational Site
state: Northamptonshire
city: Cookstown
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Frome
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Fetcham
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Woking
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Crawley
country: United Kingdom
facility: Pfizer Investigational Site
state: West Sussex
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: West Yorkshire
city: Bradford-on-Avon
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Melksham
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Swindon
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Warminster
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Bucks
country: United Kingdom
facility: Pfizer Investigational Site
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
city: Chippenham, Wiltshire
country: United Kingdom
facility: Pfizer Investigational Site
city: Cornwall
country: United Kingdom
facility: Pfizer Investigational Site
city: County Antrim, Northern Ireland
country: United Kingdom
facility: Pfizer Investigational Site
city: Darlington
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: East Sussex
country: United Kingdom
facility: Pfizer Investigational Site
city: Isle Of Wight
country: United Kingdom
facility: Pfizer Investigational Site
city: Isle Of Wight
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Westbury
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: