Official Title: “A Multicenter, Eight-Week Treatment, Single-Step Titration Open-Label Study Assessing The Percentage Of Korean Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 MG, 20 MG, And 40 MG.”

To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP â…¢ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • Prescription of 10/20/40mg dose atorvastatin based the personal risk factor that is defined in the NCEP ATP III guideline in a single patient group

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Treatment group
  • this patient group consists of dyslipidemia patients with various CVD risk factors

Primary Measures

• The primary endpoint is the percentage of subjects achieving their LDL-C target after 8 weeks of treatment. This endpoint will be assessed for subjects in the total group and repeated for subjects in each cardiovascular risk subgroup.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• 1. Percentage of subjects in the total group and each cardiovascular risk group achieving their LDL-C target after 4 weeks of treatment.
  • Time Frame: 4 weeks
    Safety Issue?: No
• 2. Change and percent change from baseline to 4 and 8 weeks of treatment for LDL-C, HDL-C, non-HDL-C, LDL-C/HDL-C ratio, TC, and TG for subjects in the total group and each cardiovascular risk group.
  • Time Frame: 4/8 weeks
    Safety Issue?: No
• 3. Percentage of subjects who achieved LDL-C target with no titration of atorvastatin and after one step titration of atorvastatin.
  • Time Frame: 4 weeks
    Safety Issue?: No
• 4. Change and percent change from baseline to 4 and 8 weeks of treatment for hs-CRP
  • Time Frame: 4/8 weeks
    Safety Issue?: No
• 5. Change and percent change from baseline to 8 weeks of treatment for MCP-1, IL- 6, and TNF-α.
  • Time Frame: 8 weeks
    Safety Issue?: No
• 6. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.
  • Time Frame: 4/8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Is a Korean , dyslipidemic outpatient
• 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 â…¢: 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:

• 1. Is pregnant or lactating
• 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00540293

Study ID Number: A2581157

ClinicalTrials.gov Identifier: NCT00540293

Health Authority: Korea: Institutional Review Board

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