Status:
COMPLETED
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Lead Sponsor:
Amgen
Conditions:
Hyperlipidemia and Mixed Dyslipidemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Eligibility Criteria
Inclusion
- \- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 \[NCT01763827\], 20110115 \[NCT01763866\], 20110116 \[NCT01763905\], 20110117 \[NCT01763918\], 20110109 \[NCT01516879\], 20120122 \[NCT01953328\], 20120332 \[NCT01984424\], 20120348 \[NCT01849497\], or 20120356 \[NCT01879319\]).
Exclusion
- Experienced a treatment-related serious adverse event that led to study drug discontinuation in the parent study
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Key Trial Info
Start Date :
April 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
3681 Patients enrolled
Trial Details
Trial ID
NCT01854918
Start Date
April 23 2013
End Date
May 31 2018
Last Update
June 11 2019
Active Locations (363)
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1
Research Site
Birmingham, Alabama, United States, 35216
2
Research Site
Birmingham, Alabama, United States, 35294
3
Research Site
Chandler, Arizona, United States, 85224
4
Research Site
Phoenix, Arizona, United States, 85020