NCT01763827

Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered by subcutaneous injection
DRUG	Ezetimibe	Administered orally once a day
BIOLOGICAL	Placebo to Evolocumab	Administered by subcutaneous injection
OTHER	Placebo to Ezetimibe	Administered orally once daily

Timeline

• Start date: 2013-01-21
• Primary completion: 2013-10-10
• Completion: 2013-10-29
• First posted: 2013-01-09
• Last updated: 2022-11-08
• Results posted: 2015-12-30

Locations

83 sites across 10 countries: United States, Australia, Belgium, Canada, Denmark, France, South Africa, South Korea, Taiwan, Turkey (Türkiye)