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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01984424 | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 | PHASE3 | COMPLETED | 511 | — | — | Dec 10, 2013 | Nov 21, 2017 | Nov 29, 2018 | 58 | United States, Australia +11 |
| 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...