At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 160 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, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
In Brief
A Phase 2 clinical trial evaluating Evolocumab, Ezetimibe, and 1 other intervention for Hyperlipidemia. Completed, enrolled 160 participants across 42 sites in 8 countries.
Detailed Summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesAustralia, Belgium, Canada, Denmark, Finland, Spain, Sweden, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartJul 2011
Primary CompletionMay 2012
TodayJul 2026
First PostedJun 17, 2011
Enrollment StartJul 28, 2011
Primary CompletionMay 8, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago
Interventions
Evolocumabbiological
Administered by subcutaneous injection
Ezetimibedrug
Administered orally once a day
Placebo to Evolocumabother
Administered by subcutaneous injection