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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01849497 | Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen | PHASE3 | COMPLETED | 149 | — | — | Apr 18, 2013 | - | Nov 29, 2018 | 26 | United States, Canada |
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...