CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 307 enrolled
Drug / intervention
Evolocumab +3 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.

Search/NCT01763905
NCT01763905Phase 3Completed
CompareCT.gov

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

Amgen·interventional·Posted Jan 9, 2013·Updated Jul 20, 2020

In Brief

A Phase 3 clinical trial evaluating Evolocumab, Placebo to Evolocumab, and 2 other interventions for Hyperlipidemia. Completed, enrolled 307 participants across 58 sites in 14 countries.

Detailed Summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2013
Enrollment StartJan 24, 2013
Primary CompletionNov 19, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago

Interventions

Evolocumabbiological

Subcutaneous injection

Placebo to Evolocumabdrug

Subcutaneous injection

Ezetimibedrug

Tablet for oral administration

Placebo to Ezetimibedrug

Tablet for oral administration