At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 986 enrolled
Drug / intervention
Evolocumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)
In Brief
A Phase 3 clinical trial evaluating Evolocumab, Atorvastatin, and 1 other intervention for Diabetes, Hyperlipidemia, Mixed Dyslipidemia. Completed, enrolled 986 participants across 110 sites in 10 countries.
Detailed Summary
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Canada, China, Colombia, France, Russia, South Korea, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartApr 2016
Primary CompletionDec 2017
TodayJul 2026
First PostedJan 25, 2016
Enrollment StartApr 14, 2016
Primary CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.4 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Atorvastatindrug
Administered orally once a day
Placeboother
Placebo to evolocumab administered by subcutaneous injection