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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00327418
Other study ID # 0981-430-102
Secondary ID A2581143
Status Completed
Phase Phase 4
First received May 16, 2006
Last updated May 8, 2007
Start date January 1997
Est. completion date February 2004

Study information

Verified date May 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2800
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Atorvastatin


Locations

Country Name City State
United Kingdom Pfizer Investigational Site Ashford Middlesex
United Kingdom Pfizer Investigational Site Ayr
United Kingdom Pfizer Investigational Site Ayr
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Belfast
United Kingdom Pfizer Investigational Site Belfast
United Kingdom Pfizer Investigational Site Belfast
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Bocastle Cornwall
United Kingdom Pfizer Investigational Site Bolton Lancashire
United Kingdom Pfizer Investigational Site Bournemouth Dorset
United Kingdom Pfizer Investigational Site Bournemouth Dorset
United Kingdom Pfizer Investigational Site Cambridge
United Kingdom Pfizer Investigational Site Carshalton Surrey
United Kingdom Pfizer Investigational Site Chesterfield Derbyshire
United Kingdom Pfizer Investigational Site Chippenham, Wiltshire
United Kingdom Pfizer Investigational Site Co. Dublin
United Kingdom Pfizer Investigational Site Corsham Wiltshire
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site Crawley West Sussex
United Kingdom Pfizer Investigational Site Crawley West Sussex
United Kingdom Pfizer Investigational Site Crownhill, Plymouth Devon
United Kingdom Pfizer Investigational Site Derby
United Kingdom Pfizer Investigational Site Dewsbury
United Kingdom Pfizer Investigational Site Dublin 8
United Kingdom Pfizer Investigational Site Dumfries
United Kingdom Pfizer Investigational Site Dundee Tayside
United Kingdom Pfizer Investigational Site Dundee Tayside
United Kingdom Pfizer Investigational Site East Kilbride
United Kingdom Pfizer Investigational Site Edgbaston Birmingham
United Kingdom Pfizer Investigational Site Edinburgh
United Kingdom Pfizer Investigational Site Edinburgh
United Kingdom Pfizer Investigational Site Epping Essex
United Kingdom Pfizer Investigational Site Epsom Surrey
United Kingdom Pfizer Investigational Site Falmouth Cornwall
United Kingdom Pfizer Investigational Site Fosterhill Aberdeen
United Kingdom Pfizer Investigational Site Fowey Cornwall
United Kingdom Pfizer Investigational Site Frenchay Bristol
United Kingdom Pfizer Investigational Site Frome Somerset
United Kingdom Pfizer Investigational Site Gateshead Tyne and Wear
United Kingdom Pfizer Investigational Site Gillingham Kent
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Harrogate North Yorkshire
United Kingdom Pfizer Investigational Site Hartlepool
United Kingdom Pfizer Investigational Site Haverfordwest Pembrokeshire
United Kingdom Pfizer Investigational Site Haverfordwest Pembrokeshire
United Kingdom Pfizer Investigational Site Haywards Heath West Sussex
United Kingdom Pfizer Investigational Site Headington Oxford
United Kingdom Pfizer Investigational Site Hemel Hempstead Hertfordshire
United Kingdom Pfizer Investigational Site Hertfordshire
United Kingdom Pfizer Investigational Site Hertfordshire
United Kingdom Pfizer Investigational Site Hetton le Hole Tyne & Wear
United Kingdom Pfizer Investigational Site Hildenborough Kent
United Kingdom Pfizer Investigational Site Huthwaite Nottingham
United Kingdom Pfizer Investigational Site Inverness
United Kingdom Pfizer Investigational Site Irvine Ayrshire
United Kingdom Pfizer Investigational Site Langside Glasgow
United Kingdom Pfizer Investigational Site Leicester
United Kingdom Pfizer Investigational Site Liverpool
United Kingdom Pfizer Investigational Site Livingston West Lothian
United Kingdom Pfizer Investigational Site Llanishen Cardiff
United Kingdom Pfizer Investigational Site Llantrisant
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Lyndon West Bromwich, West Midlands
United Kingdom Pfizer Investigational Site Maidenhead Berskhire
United Kingdom Pfizer Investigational Site Manchester M15 6sx
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Midsomer Norton Bath
United Kingdom Pfizer Investigational Site Newcastle upon Tyne
United Kingdom Pfizer Investigational Site Northallerton North Yorkshire
United Kingdom Pfizer Investigational Site Nottingham
United Kingdom Pfizer Investigational Site Nuneaton Warwickshire
United Kingdom Pfizer Investigational Site Oldham
United Kingdom Pfizer Investigational Site Ormskirk Lancashire
United Kingdom Pfizer Investigational Site Paisley
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 Plympton Devon
United Kingdom Pfizer Investigational Site Pontarddulais Swansea
United Kingdom Pfizer Investigational Site Pontefract
United Kingdom Pfizer Investigational Site Portsmouth Hampshire
United Kingdom Pfizer Investigational Site Reading Berkshire
United Kingdom Pfizer Investigational Site Redruth Cornwall
United Kingdom Pfizer Investigational Site Rugby Warwickshire
United Kingdom Pfizer Investigational Site Ryde Isle of Wight
United Kingdom Pfizer Investigational Site Saltash Cornwall
United Kingdom Pfizer Investigational Site Scunthorpe North Lincolnshire
United Kingdom Pfizer Investigational Site Sheffield South Yorkshire
United Kingdom Pfizer Investigational Site Sheffield South Yorkshire
United Kingdom Pfizer Investigational Site Sheffield South Yorkshire
United Kingdom Pfizer Investigational Site Shrewsbury Shropshire
United Kingdom Pfizer Investigational Site Slough Berkshire
United Kingdom Pfizer Investigational Site Southall Middlesex
United Kingdom Pfizer Investigational Site Southampton Hampshire
United Kingdom Pfizer Investigational Site Southampton
United Kingdom Pfizer Investigational Site Southend on Sea Essex
United Kingdom Pfizer Investigational Site St. Austell Cornwall
United Kingdom Pfizer Investigational Site Stirling Stirlingshire
United Kingdom Pfizer Investigational Site Sutton-in-Ashfield Nottinghamshire
United Kingdom Pfizer Investigational Site Swansea
United Kingdom Pfizer Investigational Site Swansea
United Kingdom Pfizer Investigational Site Titchfield Hampshire
United Kingdom Pfizer Investigational Site Trowbridge Wiltshire
United Kingdom Pfizer Investigational Site Trowbridge Wiltshire
United Kingdom Pfizer Investigational Site Truro Cornwall
United Kingdom Pfizer Investigational Site Tunbridge Wells Kent
United Kingdom Pfizer Investigational Site Wakefield
United Kingdom Pfizer Investigational Site Warminster Wiltshire
United Kingdom Pfizer Investigational Site Waterloo Liverpool
United Kingdom Pfizer Investigational Site Watford Hertfordshire
United Kingdom Pfizer Investigational Site Westbury Wiltshire
United Kingdom Pfizer Investigational Site Weston-Super-Mare Somerset
United Kingdom Pfizer Investigational Site Wigan
United Kingdom Pfizer Investigational Site Wiltshire
United Kingdom Pfizer Investigational Site Wiltshire
United Kingdom Pfizer Investigational Site Wiltshire
United Kingdom Pfizer Investigational Site Wishaw
United Kingdom Pfizer Investigational Site Wolverhampton West Midlands
United Kingdom Pfizer Investigational Site Worksop Nottinghamshire
United Kingdom Pfizer Investigational Site Wrexham Clwydd
United Kingdom Pfizer Investigational Site York Yorkshire

Sponsors (3)

Lead Sponsor Collaborator
Pfizer Department of Health, United Kingdom, Diabetes UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Neil HA, DeMicco DA, Luo D, Betteridge DJ, Colhoun HM, Durrington PN, Livingstone SJ, Fuller JH, Hitman GA; CARDS Study Investigators. Analysis of efficacy and safety in patients aged 65-75 years at randomization: Collaborative Atorvastatin Diabetes Study — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time from randomization to the occurrence of a primary clinical endpoint
Primary i.e. major coronary event or CABG or other coronary revascularization procedure
Primary or unstable angina or resuscitated cardiac arrest or stroke.
Secondary The incidence rate of a primary clinical and endpoint; the time from randomization
Secondary to the occurrence of and the incidence rate of other parameters e.g. total
Secondary mortality, any cardiovascular event, new PVD etc. and the percent change from
Secondary baseline in various lipid and lipoprotein parameters.
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