NCT01854918

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,681 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Conditions

• Hyperlipidemia and Mixed Dyslipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
DRUG	Standard of Care	Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Timeline

• Start date: 2013-04-23
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2013-05-16
• Last updated: 2019-06-11
• Results posted: 2019-06-11

Locations

363 sites across 25 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom