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A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM. The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Los Angeles, California, United States
Research Site
Hartford, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Miami, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Vero Beach, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Berkley, Michigan, United States
Start Date
May 22, 2017
Primary Completion Date
July 9, 2019
Completion Date
January 27, 2020
Last Updated
July 22, 2022
467
ACTUAL participants
Evolocumab
DRUG
Placebo
DRUG
Lead Sponsor
Amgen
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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