At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 27,564 enrolled
Drug / intervention
Evolocumab +1 morebiological
Likely dose
Evolocumab 1.0 mLfrom 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 Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Placebo for Dyslipidemia. Completed, enrolled 27,564 participants across 1,284 sites in 49 countries.
Detailed Summary
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionNov 2016
TodayJul 2026
First PostedJan 9, 2013
Enrollment StartFeb 8, 2013
Primary CompletionNov 11, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.5 years ago
Interventions
Evolocumabbiological
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Placebodrug
Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.