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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Bococizumab (PF-04950615;RN316); Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT02055976

B1481036

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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218 participants in 2 patient groups

Population A

Experimental group

Description:

A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.

Treatment:

Drug: Placebo

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Placebo

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Ezetimibe

Population B

Experimental group

Description:

A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.

Treatment:

Drug: Placebo

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Placebo

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)

Drug: Bococizumab (PF-04950615;RN316)