Familial Hypercholesterolemia
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
Interventions
DRUGAtorvastatin
Tablets taken orally once daily in the morning
DRUGSimvastatin
Tablets taken orally once daily in the morning or evening
DRUGEzetimibe
Tablet taken orally once daily in the morning or evening
Tablets taken orally once daily in the morning or evening
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With a diagnosis of homozygous familial hypercholesterolemia * All females must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study, until one month after treatment. * Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during the study period. ERT, HRT or raloxifene cannot be changed during study period. * Must follow prescribed or stricter diet, and demonstrate completion of Diet Diaries
Exclusion criteria
* A history of mental instability, drug or alcohol abuse; or have been treated or are being treated for severe psychiatric illness which, in the opinion of the Investigator, may interfere with optimal participation in the study. * With underlying disease likely to limit life span to less than 1 year. * Have previously been randomized in any studies examining ezetimibe * Pregnant or lactating women. * With known hypersensitivity or any contraindication to statin therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) measured directly | Baseline and Up to Week 12 |
| Percentage of participants with an Adverse Event (AE) | Up to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Triglycerides (TG) | Baseline and Up to Week 12 |
| Percent change from baseline in High-density-lipoprotein cholesterol (HDL-C) | Baseline and Up to Week 12 |
| Percent change from baseline in High-density-lipoprotein 2 cholesterol (HDL2-C) | Baseline and Up to Week 12 |
| Percent change from baseline in calculated LDL-C | Baseline and Up to Week 12 |
| Percent change from baseline in Apolipoprotein A-I (Apo A-I) | Baseline and Up to Week 12 |
| Percent change from baseline in Apolipoprotein B (Apo B) | Baseline and Up to Week 12 |
| Percent change from baseline in Lipoprotein(a) [Lp(a)] | Baseline and Up to Week 12 |
| Percent change from baseline in High-density-lipoprotein 3 cholesterol (HDL3-C) | Baseline and Up to Week 12 |
| Percent change from baseline in Total Cholesterol (TC) | Baseline and Up to Week 12 |
Outcome results
None listed