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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

NCT02100514 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2018-07-31

Study results available
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Summary

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

Conditions

Interventions

DRUG

Bococizumab (PF-04950615; RN316)

150 mg every 2 weeks, subcutaneous injection for 52 weeks.

OTHER

Placebo

Subcutaneous injection every 2 weeks for 52 weeks.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2016-07-15
Completion
2017-07-10

Countries

  • United States
  • Canada
  • Czechia
  • Finland
  • Netherlands
  • Norway
  • Poland
  • Puerto Rico
  • Singapore
  • South Korea
  • Sweden
  • United Kingdom

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 NCT02100514 on ClinicalTrials.gov