AFORRD: Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00141232
Collaborator
Churchill Hospital (Other)
810
59
19.9
13.7
0.7
Study Details
Study Description
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?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
810 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Nov 1, 2004
Actual Study Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Irvine | Ayrshire | United Kingdom | KA12 OAY |
| 2 | Pfizer Investigational Site | Farnworth | Bolton | United Kingdom | BL4 9AH |
| 3 | Pfizer Investigational Site | Thornhill | Cardiff | United Kingdom | CF14 9BB |
| 4 | Pfizer Investigational Site | Fowey | Cornwall | United Kingdom | PL23 1DT |
| 5 | Pfizer Investigational Site | Launceston | Cornwall | United Kingdom | PL15 9HH |
| 6 | Pfizer Investigational Site | Penzance | Cornwall | United Kingdom | TR18 4JH |
| 7 | Pfizer Investigational Site | Penzance | Cornwall | United Kingdom | TR19 7HX |
| 8 | Pfizer Investigational Site | Saltash | Cornwall | United Kingdom | PL12 6DL |
| 9 | Pfizer Investigational Site | St Austell | Cornwall | United Kingdom | PL26 7RL |
| 10 | Pfizer Investigational Site | Darlington | County Durham | United Kingdom | DL16 6QA |
| 11 | Pfizer Investigational Site | Newton Aycliffe | County Durham | United Kingdom | DL5 5NH |
| 12 | Pfizer Investigational Site | Three Bridges | Crawley | United Kingdom | RH10 1LL |
| 13 | Pfizer Investigational Site | Plymouth | Devon | United Kingdom | PL5 3JB |
| 14 | Pfizer Investigational Site | Plymouth | Devon | United Kingdom | PL6 7TH |
| 15 | Pfizer Investigational Site | Bexhill on Sea | East Sussex | United Kingdom | TN39 4SP |
| 16 | Pfizer Investigational Site | Bexhill-On-Sea | East Sussex | United Kingdom | TN40 2SD |
| 17 | Pfizer Investigational Site | Bath | England | United Kingdom | BA2 4JT |
| 18 | Pfizer Investigational Site | Dronfield, Sheffield | England | United Kingdom | S18 1RU |
| 19 | Pfizer Investigational Site | Surrey | England | United Kingdom | CR7 7JN |
| 20 | Pfizer Investigational Site | Halstead | Essex | United Kingdom | CO9 1EX |
| 21 | Pfizer Investigational Site | Stonehouse | Gloucestershire | United Kingdom | GL10 2NG |
| 22 | Pfizer Investigational Site | Southampton | Hampshire | United Kingdom | SO31 7DQ |
| 23 | Pfizer Investigational Site | Hildenborough | Kent | United Kingdom | TN11 9HL |
| 24 | Pfizer Investigational Site | Thorneton-Clevely | Lancashire | United Kingdom | FY5 3LF |
| 25 | Pfizer Investigational Site | Balham | London | United Kingdom | SW12 8EU |
| 26 | Pfizer Investigational Site | Fulham | London | United Kingdom | SW6 2HQ |
| 27 | Pfizer Investigational Site | Tooting | London | United Kingdom | SW17 9SJ |
| 28 | Pfizer Investigational Site | Hayes | Middlesex | United Kingdom | UB4 0SF |
| 29 | Pfizer Investigational Site | Wellingborough | Northamptonshire | United Kingdom | NN8 4RW |
| 30 | Pfizer Investigational Site | Cookstown | Northern Ireland | United Kingdom | BT80 8BN |
| 31 | Pfizer Investigational Site | Frome | Somerset | United Kingdom | BA11 1EZ |
| 32 | Pfizer Investigational Site | Fetcham | Surrey | United Kingdom | KT22 9LE |
| 33 | Pfizer Investigational Site | Woking | Surrey | United Kingdom | |
| 34 | Pfizer Investigational Site | Crawley | West Sussex | United Kingdom | RH10 7DX |
| 35 | Pfizer Investigational Site | Leeds | West Yorkshire | United Kingdom | LS12 1JE |
| 36 | Pfizer Investigational Site | Bradford-on-Avon | Wiltshire | United Kingdom | BA1 5DQ |
| 37 | Pfizer Investigational Site | Melksham | Wiltshire | United Kingdom | SN12 6UN |
| 38 | Pfizer Investigational Site | Swindon | Wiltshire | United Kingdom | SN25 4YZ |
| 39 | Pfizer Investigational Site | Trowbridge | Wiltshire | United Kingdom | BA14 7EG |
| 40 | Pfizer Investigational Site | Warminster | Wiltshire | United Kingdom | BA12 9AA |
| 41 | Pfizer Investigational Site | Sheffield | Yorkshire | United Kingdom | S7 2DW |
| 42 | Pfizer Investigational Site | Bath | United Kingdom | BA2 1NH | |
| 43 | Pfizer Investigational Site | Bath | United Kingdom | BA2 3HT | |
| 44 | Pfizer Investigational Site | Belfast | United Kingdom | BT4 1NT | |
| 45 | Pfizer Investigational Site | Birmingham | United Kingdom | B37 7TR | |
| 46 | Pfizer Investigational Site | Bucks | United Kingdom | HP22 5LB | |
| 47 | Pfizer Investigational Site | Chesterfield | United Kingdom | S40 4TF | |
| 48 | Pfizer Investigational Site | Chippenham, Wiltshire | United Kingdom | SN15 2SB | |
| 49 | Pfizer Investigational Site | Cornwall | United Kingdom | TR18 2RE | |
| 50 | Pfizer Investigational Site | County Antrim, Northern Ireland | United Kingdom | BT41 3AE | |
| 51 | Pfizer Investigational Site | Darlington | United Kingdom | DL3 6HZ | |
| 52 | Pfizer Investigational Site | Dundee | United Kingdom | DD2 5NH | |
| 53 | Pfizer Investigational Site | Dundee | United Kingdom | DD4 6QY | |
| 54 | Pfizer Investigational Site | East Sussex | United Kingdom | TN40 3RJ | |
| 55 | Pfizer Investigational Site | Isle Of Wight | United Kingdom | PO32 6RR | |
| 56 | Pfizer Investigational Site | Isle Of Wight | United Kingdom | PO33 2PT | |
| 57 | Pfizer Investigational Site | London | United Kingdom | N19 5EW | |
| 58 | Pfizer Investigational Site | London | United Kingdom | SW19 6DA | |
| 59 | Pfizer Investigational Site | Westbury | United Kingdom | BA13 3JD |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Churchill Hospital
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00141232
Other Study ID Numbers:
- A2581114
First Posted:
Sep 1, 2005
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021