Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects (NCT02947334) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects
China0Started 2016-10-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.