drugset / Trial / NCT03885921
Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in participants with homozygous familial hypercholesterolemia (FH). Following completion of the 12-week, double-blind, efficacy and safety parent study (P01030/MK-0653-018; NCT03884452) participants will be offered entry into this open-label, 24-month extension study.
Timeline
- Start
- 2000-10-25
- Primary completion
- 2003-07-08
- Completion
- 2003-07-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |
| Subject | Ezetimibe | Unknown | 10 mg | Oral |
| Subject | Simvastatin | Small molecule | 40 mg | Oral |