Phase 3
Completed N=770
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Source: ClinicalTrials.gov NCT02304484 ↗Enrolled (actual)
770
Serious AEs
19.9%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 526; 415; 206; 38 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
526; 415; 206; 38; 153; 14 | — |
| SECONDARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) |
-21.52; -57.23; -58.54; -55.26; -51.72; -53.65 | — |
Eligibility Criteria
Inclusion Criteria
- Completed week 80 of study 20120153 (NCT01813422).
Exclusion Criteria
- Did not complete investigational product in the 20120153 parent study
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Data sourced from ClinicalTrials.gov (NCT02304484). 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.