Hypercholesterolemia
Conditions
Keywords
(D006937)
Brief summary
The objective of this study is to assess the effectiveness of an atorvastatin treatment regimen involving starting doses between 10 and 80 mg, followed by a single-step titration (except for subjects started at 80mg), if required
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 30 to 79 years old * Triglyceride level 6.8 mmol/L at screening * LDL-C of 5.7 mmol/L at screening
Exclusion criteria
* Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. The latter are defined as: abstinence, surgical sterilization, oral contraceptives for at least 3 cycles, intrauterine device, implant, depot injection, or barrier method in conjunction with contraceptive foam or jelly. * Subjects whose blood cholesterol levels are controlled (LDL-C targets) with statins other than atorvastatin * Subjects receiving statin doses higher than the following: 10-40mg for simvastatin , 20-40mg for fluvastatin, pravastatin and lovastatin and 10-20 mg for rosuvastatin. Subjects already treated with atorvastatin at the time of screening are not eligible unless atorvastatin has been discontinued at least 2 months prior to screening * Subjects receiving 2 or more lipid lowering agents are excluded (statins + resins or fibrates or niacin or fish oils)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of subjects achieving their LDL-C target after 12 weeks of treatment according to their 10-year CHD risk category (based on the new canadian guidelines on the management and treatment of dyslipidemia). | — |
Secondary
| Measure | Time frame |
|---|---|
| The global proportion (%) of patients reaching targets when risk categories are combined The proportion (%) of subjects achieving BOTH their LDL-C and TC/HDL-C ratio targets after 6 and 12 weeks of treatment, globally and according to their 10-year | — |
Countries
Canada