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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03337308 | A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy | PHASE3 | COMPLETED | 382 | — | — | Oct 23, 2017 | Jul 18, 2018 | Apr 8, 2020 | 5 | United States |
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.
| Arm | Type | Description |
|---|---|---|
| BA 180 mg + EZE 10 mg FDC | EXPERIMENTAL | Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks |
| BA 180 mg | EXPERIMENTAL | Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks |
| EZE 10 mg | ACTIVE_COMPARATOR | Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks |
| Placebos | PLACEBO_COMPARATOR | Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Bempedoic Acid + Ezetimibe Fixed-Dose Combination | COMBINATION_PRODUCT | bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet |
| Bempedoic Acid | DRUG | bempedoic acid 180 mg tablet |
| Ezetimibe | DRUG | ezetimibe 10 mg overencapsulated tablet |
| Placebos | DRUG | placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule |
Inclusion Criteria: * Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease * Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD) * Treated with maximally tolerated statin therapy at st...