NCT01968980已完成3 期
A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 370
- 试验地点
- 87
- 主要终点
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Treated with a statin.
- •Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
- •High or very high risk of incurring a cardiovascular event.
- •Heterozygous familial hypercholesterolemia.
排除标准
- •Pregnant or breastfeeding females.
- •Cardiovascular or cerebrovascular event of procedures during the past 30 days.
- •Congestive heart failure NYHA class IV.
- •Poorly controlled hypertension.
研究组 & 干预措施
Bococizumab (PF-04950615;RN316)
Experimental
Bococizumab (PF-04950615;RN316)
干预措施: Bococizumab (PF-04950615;RN316) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline, Week 12
次要结局
- Percent Change From Baseline in Total Cholesterol (TC) at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52(Week 12, 24, 52)
- Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
- Absolute Change From Baseline in Lipoprotein (a) at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52(Week 12, 24, 52)
- Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
- Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
- Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12(Baseline, Week 12)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52(Baseline, Week 24, 52)
- Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline, Week 12)
- Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
- Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)(Baseline up to the end of study (up to 58 weeks))
- Percent Change From Baseline in Lipoprotein (a) at Week 12(Baseline, Week 12)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12(Baseline, Week 12)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52(Baseline, Week 24, 52)
- Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52(Baseline, Week 24, 52)
- Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52(Baseline, Week 24, 52)
- Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52(Baseline, Week 24, 52)
- Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52(Baseline, Week 24, 52)
- Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
- Plasma PF-04950615 Concentrations at Week 12, 24 and 52(Week 12, 24, 52)
- Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52(Baseline, Week 12, 24, 52)
- Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12(Baseline, Week 12)
- Absolute Change From Baseline in Total Cholesterol (TC) at Week 12(Baseline, Week 12)
- Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12(Baseline, Week 12)
- Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12(Baseline, Week 12)
- Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions(Baseline up to the end of study (up to 58 weeks))
研究者
研究点 (87)
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