Overview

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

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Collaborators:
Department of Health, United Kingdom
Diabetes UK
Treatments:
Atorvastatin
Atorvastatin Calcium
Criteria
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