CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 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/NCT02634580
NCT02634580Phase 3Completed
CompareCT.gov

A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Japanese Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects

Amgen·interventional·Posted Dec 18, 2015·Updated Nov 10, 2020

In Brief

A Phase 3 clinical trial evaluating Evolocumab, Ezetimibe, and 2 other interventions for Hypercholesterolemia. Completed, enrolled 61 participants across 35 sites.

Detailed Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 18, 2015
Enrollment StartFeb 27, 2016
Primary CompletionAug 10, 2017
Study CompletionMay 26, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.5 years ago

Interventions

Evolocumabbiological

Administered by subcutaneous injection

Ezetimibedrug

Tablet for oral administration

Placebo to Evolocumabdrug

Administered by subcutaneous injection

Placebo Ezetimibedrug

Tablet for oral administration