Phase 3
Completed N=149
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
Primary Hypercholesterolemia · Mixed Dyslipidemia
Source: ClinicalTrials.gov NCT01849497 ↗
Enrolled (actual)
149
Serious AEs
3.4%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 — 96.0; 89.2 percentage of participants
Summary
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 |
96.0; 89.2 | — |
| SECONDARY Percent Change From Baseline in LDL-C at Week 6 |
-59.74; -63.43 | — |
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 (NCT01849497). 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.