NCT01342211已完成2 期
A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
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
- 93
- 试验地点
- 44
- 主要终点
- Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
研究概览
简要总结
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
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
- Double (Participant, 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
- •On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
- •Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL
排除标准
- •History of a cardiovascular or cerebrovascular event or procedure during the past year.
- •Poorly controlled type 1 or type 2 diabetes mellitus.
- •Poorly controlled hypertension.
研究组 & 干预措施
Treatment A
Placebo Comparator
干预措施: Placebo (Biological)
Treatment A
Placebo Comparator
干预措施: Statin (Drug)
Treatment B
Experimental
干预措施: PF-04950615 (RN316) (Biological)
Treatment B
Experimental
干预措施: Statin (Drug)
Treatment C
Experimental
干预措施: PF-04950615 (RN316) (Biological)
Treatment C
Experimental
干预措施: Statin (Drug)
Treatment D
Experimental
干预措施: PF-04950615 (RN316) (Biological)
Treatment D
Experimental
干预措施: Satin (Drug)
Treatment E
Experimental
干预措施: PF-04950615 (RN316) (Biological)
Treatment E
Experimental
干预措施: Statin (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
时间窗: Baseline, Day 85
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Day 1 up to Day 141)
- Number of Participants With Clinically Relevant Laboratory Abnormalities(Day 1 up to Day 141)
- Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)(Day 29, 57, 85)
- Number of Participants With Anti-drug Antibody (ADA)(Day 1 up to Day 141)
- Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)(Day 29, 57, 85)
- Change From Baseline in Lipid Parameters at Day 29, 57 and 85(Baseline, Day 29, 57, 85)
- Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85(Baseline, Day 29, 57, 85)
- Number of Treatment-Emergent Adverse Events (TEAEs) by Severity(Day 1 up to Day 141)
- Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters(Day 1 up to Day 141)
研究者
研究点 (44)
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