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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

NCT02135029 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2017-12-14

Study results available
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Summary

This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Conditions

Interventions

DRUG

Bococizumab (PF-04950615;RN316)

150 mg every 2 weeks by subcutaneous injection for 24 weeks

DRUG

Atorvastatin

Atorvastatin PO QD

OTHER

Placebo for Bococizumab (PF-04950615;RN316)

150 mg every 2 weeks by subcutaneous injection for 24 weeks

OTHER

Placebo for atorvastatin

PO QD

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
2014-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Canada

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 NCT02135029 on ClinicalTrials.gov