drugset / Trial / NCT02947334

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

NCT02947334

Phase 3 Withdrawn Pfizer
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2016-10-31
Primary completion
2019-05-03
Completion
2019-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bococizumab Monoclonal antibody 150 mg Subcutaneous

Indications