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Evolocumab Pre-filled Syringe · 1 trial · 2 indications
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
| Arm | Type | Description |
|---|---|---|
| Evolocumab PFS | EXPERIMENTAL | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
| Evolocumab AI/pen | EXPERIMENTAL | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4. |
| Name | Type | Description |
|---|---|---|
| Evolocumab Pre-filled Syringe | BIOLOGICAL | Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe. |
| Evolocumab AI/pen | BIOLOGICAL | Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen. |
Inclusion Criteria: * Fasting LDL-C at screening \> 85 mg/dL * Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria: * New York Heart Association (NYHA) III or IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Type 1 diabetes or poorly...
Evolocumab Pre-filled Syringe is a monoclonal antibody being developed by Amgen Inc. for the treatment of Primary Hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood. It is also studied in patients with Mixed Dyslipidemia, a related lipid disorder.
Evolocumab Pre-filled Syringe is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is being investigated for use in cardiovascular conditions, specifically for patients with primary hypercholesterolemia.
Evolocumab Pre-filled Syringe is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for its efficacy and safety in treating lipid disorders.
Evolocumab Pre-filled Syringe has one completed Phase 3 clinical trial, identified by the National Clinical Trial number NCT01849497. The study, titled 'Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen,' enrolled 149 participants with Primary Hypercholesterolemia or Mixed Dyslipidemia.
Evolocumab Pre-filled Syringe is a monoclonal antibody that targets PCSK9, a protein that regulates cholesterol levels by degrading LDL receptors. By inhibiting PCSK9, the drug aims to increase the number of LDL receptors on liver cells, thereby reducing low-density lipoprotein (LDL) cholesterol in the blood.
Evolocumab Pre-filled Syringe is a formulation of evolocumab, a monoclonal antibody that inhibits PCSK9. The pre-filled syringe is designed for in-home administration, as studied in the Phase 3 trial NCT01849497. Evolocumab is also known by the development code AMG 145.