Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezetimibe · 7 trials · 7 indications
Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) - (High-density lipoprotein cholesterol \[HDL-C\] + triglyceride \[TG\]/5).
| Arm | Type | Description |
|---|---|---|
| Ezetimibe | EXPERIMENTAL | Ezetimibe 10-mg tablet once daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks |
| 1 | EXPERIMENTAL | ezetimibe 10 mg tablet plus simvastatin 20 mg tablet |
| 2 | ACTIVE_COMPARATOR | ezetimibe 10 mg tablet |
| 3 | ACTIVE_COMPARATOR | simvastatin 20 mg tablet |
| 4 | PLACEBO_COMPARATOR | matching placebo |
| EZ/Simva | EXPERIMENTAL | - |
| Placebo/Simva | PLACEBO_COMPARATOR | - |
| Ezetimibe: Base Study | EXPERIMENTAL | 10-mg tablet, oral taken once daily concomitantly with the participant' s current statin therapy for 8 weeks. |
| Placebo: Base Study | PLACEBO_COMPARATOR | Placebo for ezetimibe 10-mg tablet, oral taken once daily concomitantly with the participant' s current statin therapy for 8 weeks. |
| Ezetimibe: Extension | EXPERIMENTAL | 10-mg tablet, oral taken once daily concomitantly with simvastatin for 48 weeks. |
| Placebo: Extension | PLACEBO_COMPARATOR | Placebo for ezetimibe tablet, oral taken once daily concomitantly with simvastatin for 48 weeks. |
| 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 |
| Ezetimibe 10mg and Atorvastatin 10mg | ACTIVE_COMPARATOR | Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered |
| 10mg Ezetimibe/10mg Atorvastatin | EXPERIMENTAL | 10mg Ezetimibe/10mg atorvastatin combination tablet |
| Ezetimibe 10mg and Atorvastatin 80mg | ACTIVE_COMPARATOR | Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered |
| 10mg Ezetimibe/80mg Atorvastatin | EXPERIMENTAL | Ezetimibe/atorvastatin 10mg/80mg combination tablet |
| Treatment A | ACTIVE_COMPARATOR | Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1. |
| Treatment B | ACTIVE_COMPARATOR | Treatment B: subjects will receive single oral daily doses of ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through 6, followed by coadministration of a single oral dose of ezetimibe 20 mg (2 x 10 mg tablets) and cyclosporine 100 mg capsule on Day 7. |
| Name | Type | Description |
|---|---|---|
| ezetimibe | DRUG | oral tablets: ezetimibe 10 mg once daily for 12 weeks |
| Placebo | DRUG | oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period |
| Comparator: Placebo (unspecified) | DRUG | matching placebo tablet. Duration of Treatment 31 Weeks. |
| simvastatin | DRUG | simvastatin 20 mg tablet. Duration of Treatment 31 Weeks. |
| ezetimibe (plus simvastatin) | DRUG | oral tablets; ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months |
| placebo (plus simvastatin) | DRUG | tablets; placebo to match ezetimibe 10 mg (plus simvastatin 80 mg) once daily for 24 months |
| Simivastatin | DRUG | Once daily administration at dose to be determined |
| Statin | DRUG | Statin administered orally once daily at dose determined by treatment prior to enrollment by personal physician |
| Atorvastatin | DRUG | Tablets taken orally once daily in the morning |
| Placebo for Ezetimibe | DRUG | Tablets taken orally once daily in the morning or evening |
| Ezetimibe/atorvastatin 10mg/10mg FDC | DRUG | Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours). |
| Atorvastatin 10mg | DRUG | Atorvastatin 10mg given orally after an overnight fast (at least 10 hours). |
| Atorvastatin 80mg | DRUG | Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours). |
| Ezetimibe/atorvastatin 10mg/80mg FDC | DRUG | Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours). |
| Comparator: cyclosporine | DRUG | single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7. |
Inclusion Criteria: * Each subject may be of either sex and of any race/ethnicity, and must be \>=6 and \<=10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months with a LDL-C of \>159mg/dL...
Ezetimibe is a small molecule drug being developed for conditions related to high cholesterol, including atherosclerosis, primary hypercholesterolemia, hyperlipidemia, and familial hypercholesterolemia. It is intended to lower cholesterol levels in patients with these metabolic disorders.
Ezetimibe is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN. The drug is currently in Phase 3 clinical development for cholesterol-related indications.
Ezetimibe is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has completed 28 clinical trials, all of which are finished, with no active trials currently ongoing.
Ezetimibe has completed several Phase 3 trials, including NCT00867165, which studied its efficacy and safety in children with primary hypercholesterolemia, and NCT03882905, which evaluated it when added to statin therapy in adults with primary hypercholesterolemia. Another trial, NCT03884452, tested it with atorvastatin or simvastatin in familial hypercholesterolemia.
Yes, Ezetimibe is also known as SCH 58235. Clinical trial records refer to the drug by this alternative name, such as in NCT03882905, which is titled 'A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin.'