Dyslipidemias
Conditions
Brief summary
The purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.
Interventions
DRUGAtorvastatin
Atorvastatin calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 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
* Patients with high cholesterol eligible for treatment with baseline LDL-C level of less than or equal to 220 mg/dL * Willingness to follow diet
Exclusion criteria
* Triglycerides less than or equal to 400 mg/dL * Hemoglobin A1c \>10%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate in patients who achieved low-density lipoprotein cholesterol (LDL-C) level | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving LDL goal at 2 and 4 weeks | Weeks 2 and 4 |
| Lipid changes at week 4 & 8 | Weeks 4 and 8 |
Countries
Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Panama, Venezuela
Outcome results
None listed