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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Fosterhill, Aberdeen, AB25 2XG United Kingdom
Contact
1-800-718-1021
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

NCT00327418
Pfizer
Completed
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events

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CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
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)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Major Coronary Event
  • Cerebrovascular Accident
  • Coronary Artery Bypass Graft
  • Angina, Unstable
  • Revascularization
Drug: Atorvastatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2800
February 2004
Not Provided

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
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00327418
0981-430-102
A2581143
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
  • Diabetes UK
  • Department of Health, United Kingdom
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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