Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Timeline

Start

2013-10

Primary completion

2014-06

Completion

2014-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); A5 Placebo Q2W vs A5 Evolocumab Q2W; p <0.001; LS Mean Treatment Difference -73.97 (95% CI -78.54 to -69.41) NCT01953328 ↗

Drugs

Indications