Phase 3
N=5,035
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT02867813 ↗Enrolled (actual)
5,035
Serious AEs
42.2%
Results posted
Feb 2023
Primary outcome: Primary: Number of Participants Who Experienced an Adverse Event — 2144; 2084 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Evolocumab (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event |
2144; 2084 | — |
| SECONDARY Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit |
-55.93; -58.43; -56.69; -58.38; -58.52; -59.05 | — |
| SECONDARY Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL |
58.7; 61.4; 60.2; 61.6; 61.7; 61.9 | — |
Summary
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent before initiation of any study-specific activities/procedures
- Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.
Exclusion Criteria
- Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
- Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
- Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
- Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
- Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
- Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded
Data sourced from ClinicalTrials.gov (NCT02867813). 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.