drugset / Trial / NCT02947334
Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bococizumab | Monoclonal antibody | 150 mg | Subcutaneous |