Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/1/2018 |
| Start Date: | April 18, 2013 |
A Multi-center, 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 Prefilled Syringe or a Prefilled Autoinjector/Pen
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.
evolocumab in home-use using either a pre-filled syringe or autoinjector/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
21
sites
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