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Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

NCT02189837 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-10-03

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

Conditions

  • Primary Hyperlipidemia and Mixed Dyslipidemia

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

DRUG

Atorvastatin

Administered by mouth

DRUG

Placebo to Evolocumab

Administered by subcutaneous injection

DRUG

Placebo to Atorvastatin

Administered by mouth

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-08
Primary Completion
2015-02-13
Completion
2015-03-05

Countries

  • Australia

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 NCT02189837 on ClinicalTrials.gov