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Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

NCT01984424 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2018-11-29

Study results available
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Summary

The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).

Conditions

Interventions

DRUG

Atorvastatin

Atorvastatin was supplied as over-encapsulated 20 mg tablets

DRUG

Placebo to Atorvastatin

Placebo matching to atorvastatin supplied as over-encapsulated tablets

OTHER

Placebo to Ezetimibe

Placebo matching to Ezetimibe supplied as over-encapsulated tablets.

DRUG

Ezetimibe

Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.

OTHER

Placebo to Evolocumab

Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)

DRUG

Evolocumab

Evolocumab supplied as single-use prefilled autoinjector/pen(s)

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
2013-12-10
Primary Completion
2015-11-10
Completion
2017-11-21

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • South Africa
  • 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 NCT01984424 on ClinicalTrials.gov