Status:
COMPLETED
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Diabetes UK
Department of Health, United Kingdom
Conditions:
Major Coronary Event
Cerebrovascular Accident
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- Type I Diabetes Mellitus
- Any major Coronary event prior to entry into the study
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
2800 Patients enrolled
Trial Details
Trial ID
NCT00327418
Start Date
January 1 1997
End Date
February 1 2004
Last Update
May 10 2007
Active Locations (135)
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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