A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Bococizumab (Pf-04950615) In Asian Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 1
- 主要终点
- • Percent change from baseline in fasting LDL-C
研究概览
简要总结
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.
详细描述
After providing consent, subjects will enter a screening period of approximately 28 days to verify eligibility for the trial. Eligible subjects will be considered enrolled and progress to the Randomization visit. Results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. Randomized subjects will enter the 12-week treatment period, followed by a 40-week long-term treatment period and a 6 week follow-up, for a total of 58 weeks (approximately 14 months) study participation. Subjects will attend clinic visits as shown in the Schedule of Activities. Subjects will be randomized to receive either 150 mg Q2wks of bococizumab or placebo in a 1:1 ratio. Lipid levels will be blinded to the investigator and staff, subject and sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Bococizumab
Bococizumab Q2wks
干预措施: Bococizumab (Biological)
Placebo
Bococizumab placebo Q2wks
干预措施: Placebo (Drug)
结局指标
主要结局
• Percent change from baseline in fasting LDL-C
时间窗: 12weeks
次要结局
未报告次要终点