Cardiovascular Diseases, Diabetes Mellitus
Conditions
Brief summary
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.
Interventions
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 18 years of age * Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg * Existing coronary heart disease and cholesterol \> 4.0 mmol/l
Exclusion criteria
* Uncontrolled diabetes * Elevated liver function tests * Elevated creatine kinase (ck) * Triglycerides (tg) \> 4.5 mmol/l * Drug or alcohol dependency within 6 months prior to visit 1 * Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study * Woman of childbearing potential not using an acceptable method of birth control * Women who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in ldl-c at end-point after 6 weeks. | — |
Outcome results
None listed