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Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

NCT01516879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2022-07-22

Study results available
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Summary

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection once a month

BIOLOGICAL

Placebo

Administered by subcutaneous injection once a month

DRUG

Atorvastatin

Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.

DRUG

Ezetimibe

Background lipid lowering therapy: ezetimibe 10 mg orally once a day

OTHER

Diet Only

Diet only, no lipid lowering background drug given

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
2012-01-05
Primary Completion
2013-10-14
Completion
2013-10-14

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Hungary
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
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 NCT01516879 on ClinicalTrials.gov