CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events

NCT00327418

Last updated date
Study Location
Pfizer Investigational Site
Fosterhill, Aberdeen, AB25 2XG, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft, Unstable Angina, Revascularization
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Type I Diabetes Mellitus


- Any major Coronary event prior to entry into the study

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Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft, Unstable Angina, RevascularizationCARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
NCT00327418
  1. Fosterhill, Aberdeen
  2. Irvine, Ayrshire
  3. Midsomer Norton, Bath
  4. Reading, Berkshire
  5. Slough, Berkshire
  6. Maidenhead, Berskhire
  7. Edgbaston, Birmingham
  8. Frenchay, Bristol
  9. Llanishen, Cardiff
  10. Wrexham, Clwydd
  11. Bocastle, Cornwall
  12. Falmouth, Cornwall
  13. Fowey, Cornwall
  14. Penzance, Cornwall
  15. Penzance, Cornwall
  16. Redruth, Cornwall
  17. Saltash, Cornwall
  18. St. Austell, Cornwall
  19. Truro, Cornwall
  20. Chesterfield, Derbyshire
  21. Crownhill, Plymouth, Devon
  22. Plymouth, Devon
  23. Plympton, Devon
  24. Bournemouth, Dorset
  25. Bournemouth, Dorset
  26. Epping, Essex
  27. Southend on Sea, Essex
  28. Langside, Glasgow
  29. Portsmouth, Hampshire
  30. Southampton, Hampshire
  31. Titchfield, Hampshire
  32. Hemel Hempstead, Hertfordshire
  33. Watford, Hertfordshire
  34. Ryde, Isle of Wight
  35. Gillingham, Kent
  36. Hildenborough, Kent
  37. Tunbridge Wells, Kent
  38. Bolton, Lancashire
  39. Ormskirk, Lancashire
  40. Waterloo, Liverpool
  41. Manchester, M15 6sx
  42. Ashford, Middlesex
  43. Southall, Middlesex
  44. Scunthorpe, North Lincolnshire
  45. Harrogate, North Yorkshire
  46. Northallerton, North Yorkshire
  47. Sutton-in-Ashfield, Nottinghamshire
  48. Worksop, Nottinghamshire
  49. Huthwaite, Nottingham
  50. Headington, Oxford
  51. Haverfordwest, Pembrokeshire
  52. Haverfordwest, Pembrokeshire
  53. Shrewsbury, Shropshire
  54. Frome, Somerset
  55. Weston-Super-Mare, Somerset
  56. Sheffield, South Yorkshire
  57. Sheffield, South Yorkshire
  58. Sheffield, South Yorkshire
  59. Stirling, Stirlingshire
  60. Carshalton, Surrey
  61. Epsom, Surrey
  62. Pontarddulais, Swansea
  63. Dundee, Tayside
  64. Dundee, Tayside
  65. Hetton le Hole, Tyne & Wear
  66. Gateshead, Tyne and Wear
  67. Nuneaton, Warwickshire
  68. Rugby, Warwickshire
  69. Lyndon, West Bromwich, West Midlands
  70. Livingston, West Lothian
  71. Wolverhampton, West Midlands
  72. Crawley, West Sussex
  73. Crawley, West Sussex
  74. Haywards Heath, West Sussex
  75. Corsham, Wiltshire
  76. Trowbridge, Wiltshire
  77. Trowbridge, Wiltshire
  78. Warminster, Wiltshire
  79. Westbury, Wiltshire
  80. York, Yorkshire
  81. Ayr,
  82. Ayr,
  83. Bath,
  84. Bath,
  85. Bath,
  86. Bath,
  87. Bath,
  88. Belfast,
  89. Belfast,
  90. Belfast,
  91. Birmingham,
  92. Birmingham,
  93. Birmingham,
  94. Cambridge,
  95. Chippenham, Wiltshire,
  96. Co. Dublin,
  97. Coventry,
  98. Derby,
  99. Dewsbury,
  100. Dublin 8,
  101. Dumfries,
  102. East Kilbride,
  103. Edinburgh,
  104. Edinburgh,
  105. Glasgow,
  106. Glasgow,
  107. Glasgow,
  108. Hartlepool,
  109. Hertfordshire,
  110. Hertfordshire,
  111. Inverness,
  112. Leicester,
  113. Liverpool,
  114. Llantrisant,
  115. London,
  116. London,
  117. London,
  118. London,
  119. Manchester,
  120. Manchester,
  121. Manchester,
  122. Newcastle upon Tyne,
  123. Nottingham,
  124. Oldham,
  125. Paisley,
  126. Pontefract,
  127. Southampton,
  128. Swansea,
  129. Swansea,
  130. Wakefield,
  131. Wigan,
  132. Wiltshire,
  133. Wiltshire,
  134. Wiltshire,
  135. Wishaw,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Major Coronary Event
  • Cerebrovascular Accident
  • Coronary Artery Bypass Graft
  • Angina, Unstable
  • Revascularization
Intervention  ICMJE Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 16, 2006)
2800
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00327418
Other Study ID Numbers  ICMJE 0981-430-102
A2581143
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Diabetes UK
  • Department of Health, United Kingdom
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP