Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezetimibe · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: Atorvastatin 20 mg => Placebo | OTHER | Participants received atorvastatin 20 mg orally for 10 weeks (period 1) followed by placebo orally for 10 weeks (period 2), separated by a 2-week washout period. |
| Part A: Placebo => Atorvastatin 20 mg | OTHER | Participants received placebo orally for 10 weeks (period 1) followed by atorvastatin 20 mg orally for 10 weeks (period 2), separated by a 2-week washout period. |
| Part B: Ezetimibe | ACTIVE_COMPARATOR | Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks. |
| Part B: Evolocumab | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks. |
| Part C: Open-label Evolocumab | EXPERIMENTAL | Participants who completed part B and were eligible to proceed to open-label extension part C and could choose quarterly between evolocumab 420 mg once a month or evolocumab 140 mg every 2 weeks for up to 2 years. |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | Atorvastatin was supplied as over-encapsulated 20 mg tablets |
| Placebo to Atorvastatin | DRUG | Placebo matching to atorvastatin supplied as over-encapsulated tablets |
| Placebo to Ezetimibe | OTHER | Placebo matching to Ezetimibe supplied as over-encapsulated tablets. |
| Ezetimibe | DRUG | Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding. |
| Placebo to Evolocumab | OTHER | Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s) |
| Evolocumab | DRUG | Evolocumab supplied as single-use prefilled autoinjector/pen(s) |
Inclusion Criteria: * Male or female ≥ 18 to ≤ 80 years of age * Subject not at LDL-C goal * History of statin intolerance * Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks * Fasting triglycerides ≤ 400 mg/dL Exclusion Criteria: * New York Heart Association (NYHA) I...
Ezetimibe is used for hyperlipidemia, a condition of elevated lipids in the blood. It is being studied in a Phase 3 clinical trial for this indication. The drug is a small molecule developed by Amgen Inc. and is currently in clinical development, not yet approved.
Ezetimibe targets the cholesterol absorption pathway. It works by inhibiting the absorption of cholesterol from the small intestine, which helps lower lipid levels in the blood. This mechanism is relevant to its use in treating hyperlipidemia.
Ezetimibe is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug for the treatment of hyperlipidemia.
Ezetimibe is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial for hyperlipidemia has been completed, and the drug is not yet available on the market.
Ezetimibe is associated with one completed Phase 3 clinical trial, NCT01984424, titled "Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3." This trial enrolled 511 participants with hyperlipidemia across multiple countries, including the United States, Australia, and several European nations.
Ezetimibe is a distinct drug with its own mechanism of action, targeting cholesterol absorption. It is not the same as other cholesterol-lowering medications, such as statins or PCSK9 inhibitors. Its development by Amgen focuses on hyperlipidemia, and it is being evaluated in clinical trials.