CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Atorvastatin +5 moredrug
Likely dose
Atorvastatin 20 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/NCT01984424
NCT01984424Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Nov 14, 2013·Updated Nov 29, 2018

In Brief

A Phase 3 clinical trial evaluating Atorvastatin, Placebo to Atorvastatin, and 4 other interventions for Hyperlipidemia. Completed, enrolled 511 participants across 58 sites in 13 countries.

Detailed Summary

The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia
CountriesAustralia, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Norway, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 14, 2013
Enrollment StartDec 10, 2013
Primary CompletionNov 10, 2015
Study CompletionNov 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.6 years ago

Interventions

Atorvastatindrug

Atorvastatin was supplied as over-encapsulated 20 mg tablets

Placebo to Atorvastatindrug

Placebo matching to atorvastatin supplied as over-encapsulated tablets

Placebo to Ezetimibeother

Placebo matching to Ezetimibe supplied as over-encapsulated tablets.

Ezetimibedrug

Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.

Placebo to Evolocumabother

Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)

Evolocumabdrug

Evolocumab supplied as single-use prefilled autoinjector/pen(s)