Hypercholesterolemia
Conditions
Brief summary
The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.
Detailed description
This study is a long-term extension study of the protocol P00692 parent study.
Interventions
DRUGEzetimibe
Ezetimibe 10 mg tablets
DRUGAtovastatin
Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg
DRUGPlacebo
Placebo tablets matched to ezetimibe
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
Yes
Inclusion criteria
* Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692). * If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose. * If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period. * Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.
Exclusion criteria
* Has discontinued from the parent study (P00692) prior to study completion. * Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation. * Is a pregnant or lactating female. * Is human immunodeficiency virus (HIV) positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing ≥1 Adverse Event (AE) | Up to 12 months |
| Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE) | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean Percent Change from Baseline in Triglyceride Levels | Baseline and 1.5, 3, 6, 9, and 12 months |
| Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline and 1.5, 3, 6, 9, and 12 months |
| Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline and 1.5, 3, 6, 9, and 12 months |
| Mean Percent Change from Baseline in Total Cholesterol (TC) | Baseline and 1.5, 3, 6, 9, and 12 months |
| Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline and 1.5, 3, 6, 9, and 12 months |
Outcome results
None listed