CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 905 enrolled
Drug / intervention
Evolocumab +4 morebiological
Likely dose
Atorvastatin 10 mgfrom 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.

Search/NCT01516879
NCT01516879Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Long-Term Tolerability and Durable Efficacy of AMG 145 (Evolocumab) on LDL-C in Hyperlipidemic Subjects

Amgen·interventional·Posted Jan 25, 2012·Updated Jul 22, 2022

In Brief

A Phase 3 clinical trial evaluating Evolocumab, Placebo, and 3 other interventions for Hypercholesterolemia. Completed, enrolled 905 participants across 96 sites in 9 countries.

Detailed Summary

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Hungary, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartJan 5, 2012
Primary CompletionOct 14, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.4 years ago

Interventions

Evolocumabbiological

Administered by subcutaneous injection once a month

Placebobiological

Administered by subcutaneous injection once a month

Atorvastatindrug

Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.

Ezetimibedrug

Background lipid lowering therapy: ezetimibe 10 mg orally once a day

Diet Onlyother

Diet only, no lipid lowering background drug given