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

NCT01968967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2139

Last updated 2018-07-31

Study results available
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Summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Conditions

Interventions

DRUG

Bococizumab (PF-04950615; RN316)

150 mg every 2 weeks, subcutaneous injection, 12 months

OTHER

Placebo

subcutaneous injection every 2 weeks for 12 months

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-29
Primary Completion
2016-07-05
Completion
2017-07-10

Countries

  • United States
  • Canada
  • Colombia
  • France
  • Hungary
  • Lithuania
  • Mexico
  • Romania
  • Russia
  • Spain
  • Taiwan
  • 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 NCT01968967 on ClinicalTrials.gov