NCT01592240已完成2 期
A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 354
- 试验地点
- 70
- 主要终点
- Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
研究概览
简要总结
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.
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, 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
- •Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.
- •Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:
- •Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);
- •Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).
- •Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.
排除标准
- •Participation in other studies within 3 months before the current study begins and/or during study participation.
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.
- •History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV.
- •Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
- •Poorly controlled hypertension.
研究组 & 干预措施
Q28d Dosing Arm
Experimental
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.
干预措施: PBO (Drug)
Q28d Dosing Arm
Experimental
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.
干预措施: 200mg PF-04950615 (RN316) (Drug)
Q28d Dosing Arm
Experimental
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.
干预措施: 300mg PF-04950615 (RN316) (Drug)
Q14d Dosing Arm
Experimental
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.
干预措施: PBO (Drug)
Q14d Dosing Arm
Experimental
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.
干预措施: PF-04950615 (Drug)
结局指标
主要结局
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline, Week 12
次要结局
- Plasma Concentration of PF-04950615 at Week 12 and 24(Week 12, 24)
- Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Total Cholesterol at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Total Cholesterol at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24(Baseline, Week 12, 24)
- Percentage of Participants With Injection Site Adverse Events(Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups)
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Triglycerides at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24(Baseline, Week 12, 24)
- Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)(Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups)
- Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24(Baseline, Week 24)
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24(Baseline, Week 12, 24)
- Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Triglycerides at Week 12 and 24(Baseline, Week 12, 24)
- Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)(Week 12, 24)
研究者
研究点 (70)
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