Last updated on June 2020

Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

Brief description of study

This study is being done to learn more about evolocumab in Chinese people with primary hypercholesterolemia or mixed dyslipidemia. This study will see if evolocumab will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are also taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects.

Detailed Study Description

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of evolocumab in Chinese Subjects with hypercholesterolemia and mixed dyslipidemia. Subjects who have signed the informed consent form (ICF), will have fasting lipids measured and all inclusion and exclusion criteria assessed. Subjects should maintain their current diet and exercise regimen. Treatment and follow-up period will be 12 weeks with an additional phone call or other subject contact at week 14 for subjects receiving investigational product Q2W. The EOS for subjects on QM investigational product is at the week 12 visit which must be at least 30 days post last dose of investigational product.

Evolocumab and placebo will be administered by self-injection under the skin at the study site or in an appropriate non-clinic setting (e.g., at home) by spring based prefilled auto injector/pen (AI/Pen). Subjects must tolerate an injection of placebo with a prefilled auto injector/pen device to be used during the study prior to randomization.

Approximately 40 sites in China will participate in this study. The overall participants to finish the study will be approximately 450 randomly added to one of 4 groups using a 2:2:1:1 ratio.

Evolocumab 140 mg every 2 weeks (Q2W-150 subjects total) Evolocumab 420 mg once a month (QM-150 subjects total) placebo every 2 weeks (75 subjects total) placebo once a month (75 subjects total) The dose frequencies of every 2 weeks and monthly will not be blinded but the identity of investigational product Evolocumab or placebo will be blinded.

Clinical Study Identifier: NCT03433755

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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