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Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

NCT02055976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2019-02-08

Study results available
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Summary

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.

Conditions

Interventions

DRUG

Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week

DRUG

Placebo

Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week

DRUG

Ezetimibe

Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)

DRUG

Bococizumab (PF-04950615;RN316)

50 mg Q14D SC for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

100 mg Q14D SC for 16 week

DRUG

Bococizumab (PF-04950615;RN316)

150 mg Q14D SC for 16 week

DRUG

Placebo

Placebo Q14D SC for 16 week

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Japan

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 NCT02055976 on ClinicalTrials.gov