At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 615 enrolled
Drug / intervention
Evolocumab +3 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 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
In Brief
A Phase 3 clinical trial evaluating Evolocumab, Ezetimibe, and 2 other interventions for Hyperlipidemia. Completed, enrolled 615 participants across 83 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesAustralia, Belgium, Canada, Denmark, France, South Africa, South Korea, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartJan 2013
Primary CompletionOct 2013
Study CompletionOct 2013
TodayJul 2026
First PostedJan 9, 2013
Enrollment StartJan 21, 2013
Primary CompletionOct 10, 2013
Study CompletionOct 29, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.5 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Ezetimibedrug
Administered orally once a day
Placebo to Evolocumabbiological
Administered by subcutaneous injection
Placebo to Ezetimibeother
Administered orally once daily