The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
Pfizer Investigational Site
Kaohsiung City, Taiwan
Pfizer Investigational Site
Kaohsiung Hsien, Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Percentage change in LDL-C levels from baseline to Week 12
Time frame: Week 12
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
Time frame: Week 12
Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12
Time frame: Weeks 4, 8, and 12
Adverse events at Weeks 4, 8, and 12
Time frame: Baseline and at Weeks 4, 8, and 12
Clinical laboratory changes at Weeks 4, 8, and 12
Time frame: Screening and at Weeks 4, 8, and 12
Vital signs at Weeks 4, 8, and 12
Time frame: Screening and at Weeks 4, 8, and 12
Percentage change in LDL-C levels from baseline at Weeks 4 and 8
Time frame: Weeks 4 and 8
Percentage of LDL-C responders at Weeks 4 and 8
Time frame: Weeks 4 and 8
Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12
Time frame: Weeks 4, 8, and 12
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Taoyuan Hsien, Taiwan