Diabetes, Type 2Phase 4AFORRDNCT00141232
Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes
A Phase 4 study testing Atorvastatin and Omega-3 fatty acids in people with Diabetes, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 59 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 2
- What is being tested?
- Atorvastatin and Omega-3 fatty acids
- How many people
- 810 participants
- Where
- 59 sitesUnited Kingdom
- Study dates
- Nov 2004to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- They are taking prescribed lipid lowering therapy
- Have triglycerides > or = 8.0 mmol/L
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United Kingdom59 sites
Pfizer Investigational Site
Balham, London, SW12 8EU
Pfizer Investigational Site
Bath, England, BA2 4JT
Pfizer Investigational Site
Bath, BA2 1NH
Pfizer Investigational Site
Bath, BA2 3HT
Pfizer Investigational Site
Belfast, BT4 1NT
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN39 4SP
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN40 2SD
Pfizer Investigational Site
Birmingham, B37 7TR
Pfizer Investigational Site
Bradford on Avon, Wiltshire, BA1 5DQ
Pfizer Investigational Site
Bucks, HP22 5LB
Pfizer Investigational Site
Chesterfield, S40 4TF
Pfizer Investigational Site
Chippenham, Wiltshire, SN15 2SB
Pfizer Investigational Site
Cookstown, Northern Ireland, BT80 8BN
Pfizer Investigational Site
Cornwall, TR18 2RE
Pfizer Investigational Site
County Antrim, Northern Ireland, BT41 3AE
Pfizer Investigational Site
Crawley, West Sussex, RH10 7DX
Pfizer Investigational Site
Darlington, County Durham, DL16 6QA
Pfizer Investigational Site
Darlington, DL3 6HZ
Pfizer Investigational Site
Dronfield, Sheffield, England, S18 1RU
Pfizer Investigational Site
Dundee, DD2 5NH
Pfizer Investigational Site
Dundee, DD4 6QY
Pfizer Investigational Site
East Sussex, TN40 3RJ
Pfizer Investigational Site
Farnworth, Bolton, BL4 9AH
Pfizer Investigational Site
Fetcham, Surrey, KT22 9LE
Pfizer Investigational Site
Fowey, Cornwall, PL23 1DT
Pfizer Investigational Site
Frome, Somerset, BA11 1EZ
Pfizer Investigational Site
Fulham, London, SW6 2HQ
Pfizer Investigational Site
Halstead, Essex, CO9 1EX
Pfizer Investigational Site
Hayes, Middlesex, UB4 0SF
Pfizer Investigational Site
Hildenborough, Kent, TN11 9HL
Pfizer Investigational Site
Irvine, Ayrshire, KA12 OAY
Pfizer Investigational Site
Isle of Wight, PO32 6RR
Pfizer Investigational Site
Isle of Wight, PO33 2PT
Pfizer Investigational Site
Launceston, Cornwall, PL15 9HH
Pfizer Investigational Site
Leeds, West Yorkshire, LS12 1JE
Pfizer Investigational Site
London, N19 5EW
Pfizer Investigational Site
London, SW19 6DA
Pfizer Investigational Site
Melksham, Wiltshire, SN12 6UN
Pfizer Investigational Site
Newton Aycliffe, County Durham, DL5 5NH
Pfizer Investigational Site
Penzance, Cornwall, TR18 4JH
Pfizer Investigational Site
Penzance, Cornwall, TR19 7HX
Pfizer Investigational Site
Plymouth, Devon, PL5 3JB
Pfizer Investigational Site
Plymouth, Devon, PL6 7TH
Pfizer Investigational Site
Saltash, Cornwall, PL12 6DL
Pfizer Investigational Site
Sheffield, Yorkshire, S7 2DW
Pfizer Investigational Site
Southampton, Hampshire, SO31 7DQ
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL
Pfizer Investigational Site
Stonehouse, Gloucestershire, GL10 2NG
Pfizer Investigational Site
Surrey, England, CR7 7JN
Pfizer Investigational Site
Swindon, Wiltshire, SN25 4YZ
Pfizer Investigational Site
Thorneton-Clevely, Lancashire, FY5 3LF
Pfizer Investigational Site
Thornhill, Cardiff, CF14 9BB
Pfizer Investigational Site
Three Bridges, Crawley, RH10 1LL
Pfizer Investigational Site
Tooting, London, SW17 9SJ
Pfizer Investigational Site
Trowbridge, Wiltshire, BA14 7EG
Pfizer Investigational Site
Warminster, Wiltshire, BA12 9AA
Pfizer Investigational Site
Wellingborough, Northamptonshire, NN8 4RW
Pfizer Investigational Site
Westbury, BA13 3JD
Pfizer Investigational Site
Woking, Surrey
About this study
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
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
- Being tested
- Atorvastatin and Omega-3 fatty acids
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin and Omega-3 fatty acidsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Churchill Hospital
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141232
- Sponsor's protocol ID
- A2581114
- Acronym
- AFORRD
- Status last verified
- Feb 2021
- First submitted
- 30 Aug 2005
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00141232
- Acronym / sponsor ID
- AFORRD / A2581114
- Conditions
- Diabetes, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Collaborators
- Churchill Hospital
- Study start
- Nov 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- They are taking prescribed lipid lowering therapy
- Have triglycerides > or = 8.0 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin and Omega-3 fatty acids | Drug | – |
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)
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and Omega-3 fatty acids in people with Diabetes, Type 2, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 59 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.