CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 424 enrolled
Drug / intervention
Evolocumab +1 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/NCT02739984
NCT02739984Phase 3Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia

Amgen·interventional·Posted Apr 15, 2016·Updated Aug 31, 2018

In Brief

A Phase 3 clinical trial evaluating Evolocumab and Placebo to Evolocumab for Hypercholesterolemia and 2 related conditions. Completed, enrolled 424 participants across 66 sites in 7 countries.

Detailed Summary

The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
CountriesBelgium, Canada, Italy, Mexico, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 15, 2016
Enrollment StartMay 17, 2016
Primary CompletionAug 3, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.2 years ago

Interventions

Evolocumabbiological

Administered by subcutaneous injection with an automated mini doser

Placebo to Evolocumabdrug

Administered by subcutaneous injection with an automated mini doser