Phase 3
Completed N=164
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
Primary Hypercholesterolemia · Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT01879319 ↗
Enrolled (actual)
164
Serious AEs
0.6%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 — 93.9; 91.5 Percentage of participants
Summary
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8 |
93.9; 91.5 | — |
| SECONDARY Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
-67.9; -64.5 | — |
Eligibility Criteria
Inclusion Criteria
- Fasting LDL-C at screening > 85 mg/dL
- Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)
Exclusion Criteria
- New York Heart Association (NYHA) III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Type 1 diabetes or poorly controlled type 2 diabetes
- Uncontrolled hypothyroidism or hyperthyroidism
Data sourced from ClinicalTrials.gov (NCT01879319). 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.