Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03884452 | Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018) | PHASE3 | COMPLETED | 50 | — | — | May 3, 2000 | May 24, 2001 | May 10, 2024 | - | — |
| Arm | Type | Description |
|---|---|---|
| Atorvastatin 80 mg | EXPERIMENTAL | 80 mg atorvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Atorvastatin 40 mg | EXPERIMENTAL | 10 mg ezetimibe and 40 mg atorvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Atorvastatin 80 mg | EXPERIMENTAL | 10 mg ezetimibe and 80 mg atorvastatin taken orally, once daily for 12 weeks |
| Simvastatin 80 mg | EXPERIMENTAL | 80 mg simvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Simvastatin 40 mg | EXPERIMENTAL | 10 mg ezetimibe and 40 mg simvastatin taken orally, once daily for 12 weeks |
| Ezetimibe + Simvastatin 80 mg | EXPERIMENTAL | 10 mg ezetimibe and 80 mg simvastatin taken orally, once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | Tablets taken orally once daily in the morning |
| Simvastatin | DRUG | Tablets taken orally once daily in the morning or evening |
| Ezetimibe | DRUG | Tablet taken orally once daily in the morning or evening |
| Placebo for Ezetimibe | DRUG | Tablets taken orally once daily in the morning or evening |
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 mo...