Dyslipidemias
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.
Interventions
DRUGAtorvastatin
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Dyslipidemic patients who were eligible for lipid lowering therapy * Willingness to follow study diet for 1 month prior to screening and for the duration of the study
Exclusion criteria
* Use of other lipid lowering agents (6-week washout period) * Uncontrolled high blood pressure * Impaired liver function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieved LDL-C target | Weeks 2 and 4, and Week 8 with 1 step titration |
| Change and percent change from baseline in LDL-C | Weeks 2, 4, and 8 |
| Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C) | Weeks 2, 4, and 8 |
| Adverse events and laboratory test changes | Weeks 2, 4, and 8 |
| Change and percent change from baseline in total cholesterol | Weeks 2, 4, and 8 |
| Change and percent change from baseline in triglycerides | Weeks 2, 4, and 8 |
| Change and percent change from baseline in LDL/HDL ratio | Weeks 2, 4, and 8 |
Countries
Thailand
Outcome results
None listed