Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | December 2013 |
A Multicenter, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.
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).
of evolocumab in a home-use setting using either an automated mini-doser (AMD) or
autoinjector/pen (AI/pen).
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
We found this trial at
22
sites
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