Last updated on February 2019

Safety Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia

Brief description of study

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, subjects will be randomized in a ratio of 2:1 to receive either Repatha (evolocumab) QM or placebo QM.

The second part of the study is a 24-week open label extension period. During this time all subjects will receive Repatha (evolocumab) QM.

The clinical hypothesis is that subcutaneous Repatha (evolocumab) QM will be well tolerated and will result in greater reduction of LDL-C, defined as percent change from baseline at week 24, compared with placebo QM in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia.

Detailed Study Description

LDL-C = low density lipoprotein cholesterol QM = once monthly Double blind = neither the subject, the site staff nor the Sponsor study team will know whether the subject is receiving either evolocumab or placebo Open label = all subjects receive evolocumab

Clinical Study Identifier: NCT02833844

Contact Investigators or Research Sites near you

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Amgen Call Center

Research Site
Albany, NY United States

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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