Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ezetimibe simvastatin · 7 trials · 7 indications
Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of \<2mmol/l in fasting LDL-C at study end.
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke
| Arm | Type | Description |
|---|---|---|
| Ezetimibe/simvastatin | EXPERIMENTAL | - |
| Doubling statin dose | ACTIVE_COMPARATOR | - |
| Rosuvastatin | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | Arm 1: Drug |
| 2 | ACTIVE_COMPARATOR | Arm 2: Active comparator |
| 3 | ACTIVE_COMPARATOR | Arm 3: Active comparator |
| 4 | OTHER | Arm 4: drug + comparator + Placebo |
| 5 | OTHER | Arm 5: drug + comparator + Placebo |
| EZ/Simva 10/40 mg | EXPERIMENTAL | Ezetimibe 10 mg + Simvastatin 40 mg |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ezetimibe (+) simvastatin | DRUG | ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks. |
| simvastatin 40 mg or atorvastatin 20 mg | DRUG | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. |
| Rosuvastatin | DRUG | rosuvastatin 10 mg tablets, taken once daily for six weeks. |
| atorvastatin 10 mg or simvastatin 20 mg | DRUG | All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization. |
| Comparator: atorvastatin | DRUG | atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally |
| Comparator: rosuvastatin | DRUG | rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally. |
| Comparator : rosuvastatin calcium | DRUG | rosuvastatin 10mg. The treatment duration will be 6 weeks. |
| Comparator: Placebo (unspecified) | DRUG | rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks. |
| Comparator: atorvastatin calcium | DRUG | Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets. Each patient will receive 1 active treatment dose \& 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks. |
| Comparator: Placebo | DRUG | matching Placebo |
Inclusion Criteria: * Patient has not taken common statins or ezetimibe within 6 weeks of study screening or patient is currently taking a daily dose of the following statins for 6 weeks prior to study screening: simvastatin, atorvastatin, pravastatin, fluvastatin, ezetimibe, lovastatin, or ezetimi...
Ezetimibe simvastatin is an investigational small molecule being studied for hyperlipidemia, cardiovascular disorder, aortic stenosis, and hypercholesterolemia. It is a combination therapy evaluated in patients with conditions such as mixed hyperlipidemia, metabolic syndrome, and cardiovascular disease with diabetes mellitus.
Ezetimibe simvastatin is being developed by Organon & Co., a company listed on the New York Stock Exchange under the ticker OGN. The drug is currently in Phase 3 clinical development for cardiovascular indications.
Ezetimibe simvastatin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for this asset are Phase 3 studies, with no active trials currently ongoing.
Ezetimibe simvastatin has been studied in three completed Phase 3 trials: NCT00093899 in mixed hyperlipidemia, NCT00409773 in metabolic syndrome, and NCT00862251 in cardiovascular disease with diabetes mellitus. A fourth trial, NCT00651560, also evaluated the drug in hyperlipidemia.
Yes, ezetimibe simvastatin is also known as Vytorin. One clinical trial, NCT00651560, is titled 'Vytorin As Strategy To Reduce Dislipidemia In Adults,' confirming that Vytorin is the brand name for this combination drug.