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Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia

NCT02662569 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 986

Last updated 2019-01-11

Study results available
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Summary

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.

Conditions

  • Diabetes, Hyperlipidemia, Mixed Dyslipidemia

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

DRUG

Atorvastatin

Administered orally once a day

OTHER

Placebo

Placebo to evolocumab administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2017-12-06
Completion
2017-12-06

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • China
  • Colombia
  • France
  • Russia
  • South Korea
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662569 on ClinicalTrials.gov