Overview

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

Status:
Completed

Trial end date:
2015-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Atorvastatin Calcium
Bococizumab
Ezetimibe

Criteria

Inclusion Criteria:

- Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population
A).

- Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not
controlled (Population B).

Exclusion Criteria:

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality.

- Pregnant females; breastfeeding females; males and females of childbearing potential;
males and females of childbearing potential who are unwilling or unable to use a
highly effective method of contraception.

- Subjects who were administered or prior exposed to PF-04950615 and/or anti-body
targeting PCSK9.