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Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

NCT01764633 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 27564

Last updated 2024-05-28

Study results available
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Summary

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

DRUG

Placebo

Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-08
Primary Completion
2016-11-11
Completion
2016-11-11

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT01764633 on ClinicalTrials.gov