Phase 3
Completed N=3,681
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Hyperlipidemia and Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT01854918 ↗
Enrolled (actual)
3,681
Serious AEs
12.4%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 796; 1655; 929; 1789 Participants
◆ Published Evidence
Highly cited
1,491citations · ~166 / year
Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia.
Summary
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Linked Publications (4)
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Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia.
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Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus.
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Efficacy and safety of evolocumab in reducing lipids and cardiovascular events.
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PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
796; 1655; 929; 1789; 519; 1070 | — |
| SECONDARY Percent Change From Baseline in LDL-C at Weeks 48 and 104 |
7.43; -51.59; -49.96; -50.31 | — |
| SECONDARY Change From Baseline in LDL-C at Weeks 48 and 104 |
0.4; -68.8; -66.4; -67.2 | — |
Eligibility Criteria
Inclusion Criteria
- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).
Exclusion Criteria
- Experienced a treatment-related serious adverse event that led to study drug discontinuation in the 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 (NCT01854918) and the linked publication. 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.