At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 411 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 Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less
In Brief
A Phase 2 clinical trial evaluating Evolocumab, Ezetimibe, and 1 other intervention for Hyperlipidemia. Completed, enrolled 411 participants across 58 sites in 5 countries.
Detailed Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesAustralia, Belgium, Canada, Denmark, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionMar 2012
TodayJul 2026
First PostedJun 17, 2011
Enrollment StartJul 6, 2011
Primary CompletionMar 2, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.0 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Ezetimibedrug
Administered orally once a day
Placebo to Evolocumabother
Administered by subcutaneous injection