At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 970 enrolled
Drug / intervention
Evolocumab +1 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, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization
In Brief
A Phase 3 clinical trial evaluating Evolocumab and Placebo for Hypercholesterolemia. Completed, enrolled 970 participants across 226 sites in 32 countries.
Detailed Summary
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartApr 2013
Primary CompletionJul 2016
Study CompletionJul 2016
TodayJul 2026
First PostedMar 19, 2013
Enrollment StartApr 18, 2013
Primary CompletionJul 12, 2016
Study CompletionJul 29, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.3 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Placebodrug
Administered by subcutaneous injection