Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects

• Status: Withdrawn
• Trial end date: 2019-05-03
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of which approximately 600 subjects will be from sites in China. Subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bococizumab

Criteria

Inclusion Criteria:

• Males and females at the age or over 18 years of age.

• With primary hyperlipidemia or mixed dyslipidemia.

• Treated with stable daily dose of statins

• At high or very high risk of incurring a CV event

• Fasting LDL-C >=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of statins; Fasting LDL C >=77 mg/dL (1.99 mmol/L) for subjects not on highest approved dose.

• Fasting TG ≤400 mg/dL (4.51 mmol/L)

Exclusion Criteria:

• Prior exposure to bococizumab or other investigational PCSK9 inhibitor

• NYHA class IV, or Left Ventricular Ejection Fraction <25%

• Poorly controlled hypertension

• History of hemorrhagic stroke or lacunar infarction resulting in a stroke

• Untreated hyperthyroidism or TSH >1 × ULN

• Undergoing apheresis or have planned start of apheresis.