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Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

NCT01375777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 411

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 subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

DRUG

Ezetimibe

Administered orally once a day

OTHER

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-06
Primary Completion
2012-03-02
Completion
2012-03-02

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark

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 NCT01375777 on ClinicalTrials.gov