Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study

Condition(s) targeted: Dyslipidemias

Intervention: Atorvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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 Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin after 8 weeks of treatment.

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.

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

Primary outcome: 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.

Secondary outcome:

1. Percentage of subjects in the total group and each cardiovascular risk group achieving their LDL-C target after 4 weeks of treatment.

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.

3. Percentage of subjects who achieved LDL-C target with no titration of atorvastatin and after one step titration of atorvastatin.

4. Change and percent change from baseline to 4 and 8 weeks of treatment for hs-CRP

5. Change and percent change from baseline to 8 weeks of treatment for MCP-1, IL- 6, and TNF-α.

6. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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 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:

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)

Pfizer Investigational Site, Seoul 137-701, Korea, Republic of

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of

Pfizer Investigational Site, Seoul 136-705, Korea, Republic of

Pfizer Investigational Site, Gyeonggi-do 463-707, Korea, Republic of

Pfizer Investigational Site, Seoul 120-752, Korea, Republic of

Pfizer Investigational Site, Seoul 110-746, Korea, Republic of

Pfizer Investigational Site, Seoul 143-914, Korea, Republic of

Pfizer Investigational Site, Incheon 405-760, Korea, Republic of

Pfizer Investigational Site, Daejeon 302-718, Korea, Republic of

Pfizer Investigational Site, Gwangju 501-757, Korea, Republic of

Pfizer Investigational Site, Gwangju 503-715, Korea, Republic of

Pfizer Investigational Site, SEOUL 138-736, Korea, Republic of

Pfizer Investigational Site, Daegu 700-712, Korea, Republic of

Pfizer Investigational Site, Busan 602-739, Korea, Republic of

Pfizer Investigational Site, Busan 614-735, Korea, Republic of

Pfizer Investigational Site, Seoul 134-010, Korea, Republic of

Pfizer Investigational Site, Gyeonggi-do 431-070, Korea, Republic of

Pfizer Investigational Site, Kyunggi-do 420-717, Korea, Republic of

Pfizer Investigational Site, Seoul, Korea 135-710, Korea, Republic of

Pfizer Investigational Site, Daegu, Korea 705-717, Korea, Republic of

To obtain contact information for a study center near you, click here.

Starting date: October 2007
Ending date: May 2008
Last updated: June 3, 2008