Status:
COMPLETED
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
Lead Sponsor:
Amgen
Conditions:
Primary Hypercholesterolemia
Mixed Dyslipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Fasting LDL-C at screening \> 85 mg/dL
- Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)
Exclusion
- 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
Key Trial Info
Start Date :
April 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT01849497
Start Date
April 18 2013
Last Update
November 29 2018
Active Locations (26)
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1
Research Site
Encino, California, United States, 91436
2
Research Site
Thousand Oaks, California, United States, 91360
3
Research Site
Ventura, California, United States, 93003
4
Research Site
Westlake Village, California, United States, 91361