CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 310 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/NCT01652703
NCT01652703Phase 2Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Stable Statin Therapy in Japanese Subjects With Hypercholesterolemia and High Cardiovascular Risk

Amgen·interventional·Posted Jul 30, 2012·Updated Nov 28, 2018

In Brief

A Phase 2 clinical trial evaluating Evolocumab and Placebo for Hypercholesterolemia and High Risk for Cardiovascular Events. Completed, enrolled 310 participants across 42 sites.

Detailed Summary

The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia and High Risk for Cardiovascular Events
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2012
Enrollment StartJul 10, 2012
Primary CompletionMay 14, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.9 years ago

Interventions

Evolocumabbiological

Administered by subcutaneous injection

Placeboother

Administered by subcutaneous injection