Hyperlipidemias
Conditions
Brief summary
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.
Interventions
DRUGatorvastatin
Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol * Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of \<400 mg/dL
Exclusion criteria
* Type I diabetes mellitus * Secondary causes of high cholesterol * Elevated liver enzymes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in LDL-C levels from baseline to Week 12 | Week 12 |
| Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical laboratory changes at Weeks 4, 8, and 12 | Screening and at Weeks 4, 8, and 12 |
| Vital signs at Weeks 4, 8, and 12 | Screening and at Weeks 4, 8, and 12 |
| Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 |
| Percentage of LDL-C responders at Weeks 4 and 8 | Weeks 4 and 8 |
| Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12 | Weeks 4, 8, and 12 |
| Percentage change in LDL-C levels from baseline at Weeks 4 and 8 | Weeks 4 and 8 |
| Adverse events at Weeks 4, 8, and 12 | Baseline and at Weeks 4, 8, and 12 |
Countries
Taiwan
Outcome results
None listed