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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

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NCT00327418

Last updated on December 12, 2019
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Study Location
Pfizer Investigational Site
Fosterhill, Aberdeen, AB25 2XG United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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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 Center Pfizer
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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