CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 409 enrolled
Drug / intervention
Atorvastatin +2 moredrug
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/NCT01953328
NCT01953328Phase 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 Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

Amgen·interventional·Posted Sep 30, 2013·Updated Dec 23, 2015

In Brief

A Phase 3 clinical trial evaluating Atorvastatin, Evolocumab, and 1 other intervention for Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events. Completed, enrolled 409 participants across 54 sites.

Detailed Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 30, 2013
Enrollment StartOct 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.8 years ago

Interventions

Atorvastatindrug

Administered orally once a day

Evolocumabbiological

Administered by subcutaneous injection

Placebo to Evolocumabother

Administered by subcutaneous injection