CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00327418
Collaborator
Diabetes UK (Other), Department of Health, United Kingdom (Other)
2,800
135
85
20.7
0.2
Study Details
Study Description
Brief Summary
A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or who currently smoke, but who do not have established corornary heart disease or other macrovascular disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
A Double Blind Placebo Controlled Study of Atorvastatin as Prevention of CHD in High Risk Patients With Non-Insulin Dependent Diabetes Mellitus (Collaborative Atorvastatin Study - CARDS)
Study Start Date
:
Jan 1, 1997
Study Completion Date
:
Feb 1, 2004
Outcome Measures
Primary Outcome Measures
- Time from randomization to the occurrence of a primary clinical endpoint []
- i.e. major coronary event or CABG or other coronary revascularization procedure []
- or unstable angina or resuscitated cardiac arrest or stroke. []
Secondary Outcome Measures
- The incidence rate of a primary clinical and endpoint; the time from randomization []
- to the occurrence of and the incidence rate of other parameters e.g. total []
- mortality, any cardiovascular event, new PVD etc. and the percent change from []
- baseline in various lipid and lipoprotein parameters. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Patients must have a documented history of at least one of the following:
-
Hypertension (defined as systolic blood pressure 140 mmHg or a diastolic blood pressure 90 mmHg (defined as the disapperance of all sound [Korotkoff Phase V] or receiving anti-hypertensive treatment. Blood pressure should be measured after sitting the patient quietly for 3 minutes).
-
Retinopathy (defined as any of the following; non-proliferative retinopathy, pre-pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or history of photocoagulation).
-
Microalbuminuria (defined as either, Albumin creatinine ratio > than = to 2.5 mg/mmol, or Albumin excretion rate on a timed collection > than = to 20 mcg/min (> than = to 30 mg/24hrs) on two successive occasions, or a positive micral or other strip test).
-
Macroalbuminuria (defined as either; Albustix or other dipstick evidence of gross proteinuria, Albumin creatinine ratio > than = to 25 mg/mmol; or Albumin excretion rate on a timed collection > than = 200 mcg/min (> than = 300 mg/24hrs) on two sucessive occasions).
-
Current smoker
Exclusion Criteria:
-
Type I Diabetes Mellitus
-
Any major Coronary event prior to entry into the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Fosterhill | Aberdeen | United Kingdom | AB25 2XG |
| 2 | Pfizer Investigational Site | Irvine | Ayrshire | United Kingdom | KA12 0AY |
| 3 | Pfizer Investigational Site | Midsomer Norton | Bath | United Kingdom | BA3 2UH |
| 4 | Pfizer Investigational Site | Reading | Berkshire | United Kingdom | RG2 7AG |
| 5 | Pfizer Investigational Site | Slough | Berkshire | United Kingdom | SL1 2AD |
| 6 | Pfizer Investigational Site | Maidenhead | Berskhire | United Kingdom | SL6 6EL |
| 7 | Pfizer Investigational Site | Edgbaston | Birmingham | United Kingdom | B15 2TH |
| 8 | Pfizer Investigational Site | Frenchay | Bristol | United Kingdom | BS16 1LE |
| 9 | Pfizer Investigational Site | Llanishen | Cardiff | United Kingdom | CF14 5GJ |
| 10 | Pfizer Investigational Site | Wrexham | Clwydd | United Kingdom | LL13 7TD |
| 11 | Pfizer Investigational Site | Bocastle | Cornwall | United Kingdom | PL35 0BG |
| 12 | Pfizer Investigational Site | Falmouth | Cornwall | United Kingdom | TR11 2LH |
| 13 | Pfizer Investigational Site | Fowey | Cornwall | United Kingdom | PL23 1DT |
| 14 | Pfizer Investigational Site | Penzance | Cornwall | United Kingdom | TR18 4JH |
| 15 | Pfizer Investigational Site | Penzance | Cornwall | United Kingdom | TR19 7HX |
| 16 | Pfizer Investigational Site | Redruth | Cornwall | United Kingdom | TR15 2LL |
| 17 | Pfizer Investigational Site | Saltash | Cornwall | United Kingdom | PL12 6DL |
| 18 | Pfizer Investigational Site | St. Austell | Cornwall | United Kingdom | PL26 7RL |
| 19 | Pfizer Investigational Site | Truro | Cornwall | United Kingdom | TR1 3LJ |
| 20 | Pfizer Investigational Site | Chesterfield | Derbyshire | United Kingdom | S40 4TF |
| 21 | Pfizer Investigational Site | Crownhill, Plymouth | Devon | United Kingdom | PL5 3JB |
| 22 | Pfizer Investigational Site | Plymouth | Devon | United Kingdom | PL6 7TH |
| 23 | Pfizer Investigational Site | Plympton | Devon | United Kingdom | PL7 1AD |
| 24 | Pfizer Investigational Site | Bournemouth | Dorset | United Kingdom | BH7 7DW |
| 25 | Pfizer Investigational Site | Bournemouth | Dorset | United Kingdom | BH8 9EW |
| 26 | Pfizer Investigational Site | Epping | Essex | United Kingdom | CM16 6TN |
| 27 | Pfizer Investigational Site | Southend on Sea | Essex | United Kingdom | SS1 2AB |
| 28 | Pfizer Investigational Site | Langside | Glasgow | United Kingdom | G42 9TY |
| 29 | Pfizer Investigational Site | Portsmouth | Hampshire | United Kingdom | PO6 3LY |
| 30 | Pfizer Investigational Site | Southampton | Hampshire | United Kingdom | SO31 7DQ |
| 31 | Pfizer Investigational Site | Titchfield | Hampshire | United Kingdom | PO14 4EH |
| 32 | Pfizer Investigational Site | Hemel Hempstead | Hertfordshire | United Kingdom | HP2 4AD |
| 33 | Pfizer Investigational Site | Watford | Hertfordshire | United Kingdom | WD18 0HB |
| 34 | Pfizer Investigational Site | Ryde | Isle of Wight | United Kingdom | PO33 2EH |
| 35 | Pfizer Investigational Site | Gillingham | Kent | United Kingdom | ME7 5NY |
| 36 | Pfizer Investigational Site | Hildenborough | Kent | United Kingdom | TN11 9HL |
| 37 | Pfizer Investigational Site | Tunbridge Wells | Kent | United Kingdom | TN1 2DX |
| 38 | Pfizer Investigational Site | Bolton | Lancashire | United Kingdom | BL4 0JR |
| 39 | Pfizer Investigational Site | Ormskirk | Lancashire | United Kingdom | L39 2AZ |
| 40 | Pfizer Investigational Site | Waterloo | Liverpool | United Kingdom | L22 0LG |
| 41 | Pfizer Investigational Site | Manchester | M15 6sx | United Kingdom | |
| 42 | Pfizer Investigational Site | Ashford | Middlesex | United Kingdom | TW15 2TU |
| 43 | Pfizer Investigational Site | Southall | Middlesex | United Kingdom | UB1 3HW |
| 44 | Pfizer Investigational Site | Scunthorpe | North Lincolnshire | United Kingdom | DN15 7BH |
| 45 | Pfizer Investigational Site | Harrogate | North Yorkshire | United Kingdom | HG2 7SX |
| 46 | Pfizer Investigational Site | Northallerton | North Yorkshire | United Kingdom | DL6 1JG |
| 47 | Pfizer Investigational Site | Sutton-in-Ashfield | Nottinghamshire | United Kingdom | NG17 4JL |
| 48 | Pfizer Investigational Site | Worksop | Nottinghamshire | United Kingdom | S80 1HP |
| 49 | Pfizer Investigational Site | Huthwaite | Nottingham | United Kingdom | NG17 2LR |
| 50 | Pfizer Investigational Site | Headington | Oxford | United Kingdom | OX3 7LJ |
| 51 | Pfizer Investigational Site | Haverfordwest | Pembrokeshire | United Kingdom | SA61 1QX |
| 52 | Pfizer Investigational Site | Haverfordwest | Pembrokeshire | United Kingdom | SA61 2PZ |
| 53 | Pfizer Investigational Site | Shrewsbury | Shropshire | United Kingdom | SY3 8XG |
| 54 | Pfizer Investigational Site | Frome | Somerset | United Kingdom | BA11 1EZ |
| 55 | Pfizer Investigational Site | Weston-Super-Mare | Somerset | United Kingdom | BS23 4TQ |
| 56 | Pfizer Investigational Site | Sheffield | South Yorkshire | United Kingdom | S5 7HD |
| 57 | Pfizer Investigational Site | Sheffield | South Yorkshire | United Kingdom | S5 7QB |
| 58 | Pfizer Investigational Site | Sheffield | South Yorkshire | United Kingdom | S7 2DW |
| 59 | Pfizer Investigational Site | Stirling | Stirlingshire | United Kingdom | FK8 2AU |
| 60 | Pfizer Investigational Site | Carshalton | Surrey | United Kingdom | SM5 1AA |
| 61 | Pfizer Investigational Site | Epsom | Surrey | United Kingdom | KT18 7EG |
| 62 | Pfizer Investigational Site | Pontarddulais | Swansea | United Kingdom | SA4 1TL |
| 63 | Pfizer Investigational Site | Dundee | Tayside | United Kingdom | DD1 9SY |
| 64 | Pfizer Investigational Site | Dundee | Tayside | United Kingdom | DD2 5NH |
| 65 | Pfizer Investigational Site | Hetton le Hole | Tyne & Wear | United Kingdom | DH5 9EZ |
| 66 | Pfizer Investigational Site | Gateshead | Tyne and Wear | United Kingdom | NE9 6SX |
| 67 | Pfizer Investigational Site | Nuneaton | Warwickshire | United Kingdom | CV10 7DJ |
| 68 | Pfizer Investigational Site | Rugby | Warwickshire | United Kingdom | CV22 5PX |
| 69 | Pfizer Investigational Site | Lyndon | West Bromwich, West Midlands | United Kingdom | B71 4HJ |
| 70 | Pfizer Investigational Site | Livingston | West Lothian | United Kingdom | EH54 6PP |
| 71 | Pfizer Investigational Site | Wolverhampton | West Midlands | United Kingdom | WV10 0QP |
| 72 | Pfizer Investigational Site | Crawley | West Sussex | United Kingdom | RH10 1LL |
| 73 | Pfizer Investigational Site | Crawley | West Sussex | United Kingdom | RH10 7DX |
| 74 | Pfizer Investigational Site | Haywards Heath | West Sussex | United Kingdom | RH16 4EX |
| 75 | Pfizer Investigational Site | Corsham | Wiltshire | United Kingdom | SN13 9DL |
| 76 | Pfizer Investigational Site | Trowbridge | Wiltshire | United Kingdom | BA14 7EG |
| 77 | Pfizer Investigational Site | Trowbridge | Wiltshire | United Kingdom | BA14 9AR |
| 78 | Pfizer Investigational Site | Warminster | Wiltshire | United Kingdom | BA14 9AA |
| 79 | Pfizer Investigational Site | Westbury | Wiltshire | United Kingdom | BA13 3JD |
| 80 | Pfizer Investigational Site | York | Yorkshire | United Kingdom | YO31 8HE |
| 81 | Pfizer Investigational Site | Ayr | United Kingdom | KA6 6DX | |
| 82 | Pfizer Investigational Site | Ayr | United Kingdom | KA7 2AA | |
| 83 | Pfizer Investigational Site | Bath | United Kingdom | BA1 2SR | |
| 84 | Pfizer Investigational Site | Bath | United Kingdom | BA1 3NG | |
| 85 | Pfizer Investigational Site | Bath | United Kingdom | BA2 1NH | |
| 86 | Pfizer Investigational Site | Bath | United Kingdom | BA2 3HT | |
| 87 | Pfizer Investigational Site | Bath | United Kingdom | BA2 4BY | |
| 88 | Pfizer Investigational Site | Belfast | United Kingdom | BT12 6BA | |
| 89 | Pfizer Investigational Site | Belfast | United Kingdom | BT14 6AB | |
| 90 | Pfizer Investigational Site | Belfast | United Kingdom | BT9 7AB | |
| 91 | Pfizer Investigational Site | Birmingham | United Kingdom | B15 2SQ | |
| 92 | Pfizer Investigational Site | Birmingham | United Kingdom | B37 7TR | |
| 93 | Pfizer Investigational Site | Birmingham | United Kingdom | B9 5SS | |
| 94 | Pfizer Investigational Site | Cambridge | United Kingdom | CB2 2QQ | |
| 95 | Pfizer Investigational Site | Chippenham, Wiltshire | United Kingdom | SN15 2SB | |
| 96 | Pfizer Investigational Site | Co. Dublin | United Kingdom | ||
| 97 | Pfizer Investigational Site | Coventry | United Kingdom | CV1 4FH | |
| 98 | Pfizer Investigational Site | Derby | United Kingdom | DE22 3DT | |
| 99 | Pfizer Investigational Site | Dewsbury | United Kingdom | WF13 4HS | |
| 100 | Pfizer Investigational Site | Dublin 8 | United Kingdom | ||
| 101 | Pfizer Investigational Site | Dumfries | United Kingdom | DG1 4AP | |
| 102 | Pfizer Investigational Site | East Kilbride | United Kingdom | G75 8RG | |
| 103 | Pfizer Investigational Site | Edinburgh | United Kingdom | EH16 4SA | |
| 104 | Pfizer Investigational Site | Edinburgh | United Kingdom | EH4 2XU | |
| 105 | Pfizer Investigational Site | Glasgow | United Kingdom | G12 0YN | |
| 106 | Pfizer Investigational Site | Glasgow | United Kingdom | G4 0SF | |
| 107 | Pfizer Investigational Site | Glasgow | United Kingdom | G51 4TF | |
| 108 | Pfizer Investigational Site | Hartlepool | United Kingdom | TS24 9AH | |
| 109 | Pfizer Investigational Site | Hertfordshire | United Kingdom | AL7 4HQ | |
| 110 | Pfizer Investigational Site | Hertfordshire | United Kingdom | SG1 4AB | |
| 111 | Pfizer Investigational Site | Inverness | United Kingdom | IV2 3UJ | |
| 112 | Pfizer Investigational Site | Leicester | United Kingdom | LE5 4PW | |
| 113 | Pfizer Investigational Site | Liverpool | United Kingdom | L7 8XP | |
| 114 | Pfizer Investigational Site | Llantrisant | United Kingdom | CF72 8XR | |
| 115 | Pfizer Investigational Site | London | United Kingdom | N18 1QX | |
| 116 | Pfizer Investigational Site | London | United Kingdom | NW3 2QG | |
| 117 | Pfizer Investigational Site | London | United Kingdom | W12 0NN | |
| 118 | Pfizer Investigational Site | London | United Kingdom | W6 8RF | |
| 119 | Pfizer Investigational Site | Manchester | United Kingdom | M41 5SL | |
| 120 | Pfizer Investigational Site | Manchester | United Kingdom | M6 8HD | |
| 121 | Pfizer Investigational Site | Manchester | United Kingdom | M8 5RB | |
| 122 | Pfizer Investigational Site | Newcastle upon Tyne | United Kingdom | NE4 6BE | |
| 123 | Pfizer Investigational Site | Nottingham | United Kingdom | NG7 2UH | |
| 124 | Pfizer Investigational Site | Oldham | United Kingdom | OL1 2JH | |
| 125 | Pfizer Investigational Site | Paisley | United Kingdom | PA2 9PN | |
| 126 | Pfizer Investigational Site | Pontefract | United Kingdom | WF8 1PL | |
| 127 | Pfizer Investigational Site | Southampton | United Kingdom | SO14 0YG | |
| 128 | Pfizer Investigational Site | Swansea | United Kingdom | SA1 1HW | |
| 129 | Pfizer Investigational Site | Swansea | United Kingdom | SA1 4DF | |
| 130 | Pfizer Investigational Site | Wakefield | United Kingdom | WF1 4DG | |
| 131 | Pfizer Investigational Site | Wigan | United Kingdom | WN1 1XX | |
| 132 | Pfizer Investigational Site | Wiltshire | United Kingdom | BA15 1DQ | |
| 133 | Pfizer Investigational Site | Wiltshire | United Kingdom | SN12 7EA | |
| 134 | Pfizer Investigational Site | Wiltshire | United Kingdom | SP2 8BJ | |
| 135 | Pfizer Investigational Site | Wishaw | United Kingdom | ML2 0DP |
Sponsors and Collaborators
- Pfizer
- Diabetes UK
- Department of Health, United Kingdom
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00327418
Other Study ID Numbers:
- 0981-430-102
- A2581143
First Posted:
May 18, 2006
Last Update Posted:
May 10, 2007
Last Verified:
May 1, 2007