Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
NCT ID: NCT00540293
Last Updated: 2021-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
425 participants
INTERVENTIONAL
2007-10-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
this patient group consists of dyslipidemia patients with various CVD risk factors
Atorvastatin
Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
Interventions
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Atorvastatin
Prescription of 10/20/40mg dose atorvastatin based on the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group
Eligibility Criteria
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Inclusion Criteria
2. Is eligible for LDL-lowering drug therapy at screening and baseline as determined by the following LDL-cholesterol (LDL-C) cut-off points defined by NCEP ATP Ⅲ: 2. 1 LDL-C ≥ 190 mg/dL for subjects with 0 or 1 CHD risk factor 2. 2 LDL-C ≥ 160 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk \< 10 % 2. 3 LDL-C ≥ 130 mg/dL for subjects with 2 or more CHD risk factors and 10 year risk 10-20 % 2. 4 LDL-C ≥ 100 mg/dL for subjects with documented CHD or CHD risk equivalents (10-year risk \> 20 %)
3. Has LDL-C ≤ 220mg/dL at baseline 4. Has triglyceride level ≤ 600mg/dL at baseline
Exclusion Criteria
2. Has present myopathy or history of myopathy or has personal or familial history of hereditary muscular disorders or any history of rhabdomyolysis
3. Has history of intolerance or hypersensitivity to atorvastatin or other statins
4. Uncontrolled hypertension (i.e. moderate hypertension, sitting systolic BP ≥ 160mmHg and/or diastolic BP ≥ 100mmHg)
5. Has HbAlc \> 10%
6. Has any severe disease of has had any major problem or surgical procedure within the 3 months prior to screening that is likely to jeopardize the planned termination of the study. (e.g., any carcinoma, coronary angioplasty, coronary artery bypass graft, cardiac infarct, severe or unstable angina pectoris)
18 Years
80 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Daegu, Korea, South Korea
Pfizer Investigational Site
Seoul, Korea, South Korea
Pfizer Investigational Site
Busan, , South Korea
Pfizer Investigational Site
Busan, , South Korea
Pfizer Investigational Site
Daegu, , South Korea
Pfizer Investigational Site
Daejeon, , South Korea
Pfizer Investigational Site
Gwangju, , South Korea
Pfizer Investigational Site
Gwangju, , South Korea
Pfizer Investigational Site
Gyeonggi-do, , South Korea
Pfizer Investigational Site
Gyeonggi-do, , South Korea
Pfizer Investigational Site
Incheon, , South Korea
Pfizer Investigational Site
Kyunggi-do, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A2581157
Identifier Type: -
Identifier Source: org_study_id
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