CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,974 enrolled
Drug / intervention
Evolocumab +2 morebiological
Likely dose
Evolocumab 1.0 mLfrom 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/NCT02207634
NCT02207634Phase 3Completed
CompareCT.gov

A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial

Amgen·interventional·Posted Aug 4, 2014·Updated Jan 16, 2018

In Brief

A Phase 3 clinical trial evaluating Evolocumab, Placebo, and 1 other intervention for Dyslipidemia. Completed, enrolled 1,974 participants across 416 sites in 30 countries.

Detailed Summary

This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartSep 10, 2014
Primary CompletionNov 11, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.9 years ago

Interventions

Evolocumabbiological

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Placebodrug

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Background Statin Therapydrug

Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.