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A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

NCT01968980 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2017-06-26

Study results available
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Summary

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

Conditions

  • Heterozygous Familial Hypercholesterolemia

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
2013-10-23
Primary Completion
2016-04-15
Completion
2016-04-15

Countries

  • United States
  • Bulgaria
  • Canada
  • Finland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01968980 on ClinicalTrials.gov