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Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

NCT01763827 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2022-11-08

Study results available
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Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

DRUG

Ezetimibe

Administered orally once a day

BIOLOGICAL

Placebo to Evolocumab

Administered by subcutaneous injection

OTHER

Placebo to Ezetimibe

Administered orally once daily

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
2013-01-21
Primary Completion
2013-10-10
Completion
2013-10-29

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • South Africa
  • South Korea
  • Taiwan
  • Turkey (Türkiye)

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 NCT01763827 on ClinicalTrials.gov