Phase 3
Completed N=905
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
Source: ClinicalTrials.gov NCT01516879 ↗Enrolled (actual)
905
Serious AEs
5.1%
Results posted
Sep 2015
Primary outcomePrimary: Percent Change From Baseline in LDL-C at Week 52 — 6.83; -50.14 percent change — p=<0.001
Summary
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-C at Week 52 |
6.83; -50.14 | <0.001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 52 |
5.1; -52.7 | <0.001 sig |
| SECONDARY Percentage of Participants With an LDL-C Response at Week 52 |
6.4; 82.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Week 12 |
3.17; -54.35 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 12 |
2.85; -32.30 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 52 |
5.26; -28.18 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52 |
8.44; -41.82 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 52 |
2.94; -41.26 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52 |
6.47; -30.67 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52 |
4.46; -41.75 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 52 |
-5.37; -27.72 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 52 |
8.99; -2.55 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52 |
0.35; 5.77 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52 |
31.89; 2.74 | <0.001 sig |
| SECONDARY Percent Change From Week 12 to Week 52 in LDL-C |
2.57; 2.44 | 0.94 |
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent.
- Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:
- < 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent
- < 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
- OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
- Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria
- New York Heart Association (NYHA) II-IV heart failure, or last known left ventricular ejection fraction < 30%
- Uncontrolled cardiac arrhythmia
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes
- Uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT01516879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.