Status:
COMPLETED
Open Label Study of Long Term Evaluation Against LDL-C Trial
Lead Sponsor:
Amgen
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Eligibility Criteria
Inclusion
- Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
Exclusion
- Experienced a treatment-related serious adverse event that led to investigational product (IP) 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 :
October 7 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2018
Estimated Enrollment :
1324 Patients enrolled
Trial Details
Trial ID
NCT01439880
Start Date
October 7 2011
End Date
June 20 2018
Last Update
September 21 2022
Active Locations (187)
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1
Research Site
Birmingham, Alabama, United States, 35216
2
Research Site
Birmingham, Alabama, United States, 35294
3
Research Site
Tucson, Arizona, United States, 85710
4
Research Site
Little Rock, Arkansas, United States, 72205