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LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

NCT01763866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2067

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 administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

DRUG

Ezetimibe

Administered orally once a day

DRUG

Placebo to Evolocumab

Administered by subcutaneous injection

DRUG

Placebo to Ezetimibe

Administered orally once a day

DRUG

Atorvastatin

Administered orally once a day

DRUG

Rosuvastatin

Administered orally once a day

DRUG

Simvastatin

Administered orally once a day

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
2013-01-15
Primary Completion
2013-11-12
Completion
2013-12-04

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

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 NCT01763866 on ClinicalTrials.gov