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Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

NCT02739984 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2018-08-31

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection with an automated mini doser

DRUG

Placebo to Evolocumab

Administered by subcutaneous injection with an automated mini doser

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-17
Primary Completion
2017-08-03
Completion
2017-08-03

Countries

  • United States
  • Belgium
  • Canada
  • Italy
  • Mexico
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases
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 NCT02739984 on ClinicalTrials.gov