NCT01972178终止2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia
Pronova BioPharma29 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 113
- 试验地点
- 29
- 主要终点
- Percent change in Non-HDL-C from baseline to Week 12
研究概览
简要总结
The objective of this study is
- To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameter from baseline after 12 weeks of treatment
- To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters
详细描述
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting triglycerides 200-499 mg/dl
- •Non-HDL-C > 130 mg/dl
- •Stable statin treatment
排除标准
- •Type I diabetes or uncontrolled type II diabetes
- •Recent cardiovascular or coronary event
- •History of pancreatitis
- •History or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data
- •Uncontrolled hypertension
研究组 & 干预措施
PRC-4016
Experimental
PRC-4016, oral administration once daily, capsule
干预措施: PRC-4016 (Drug)
PRC-4016
Experimental
PRC-4016, oral administration once daily, capsule
干预措施: Statins (Drug)
Placebo
Placebo Comparator
Placebo, oral administration once daily, capsule
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Placebo, oral administration once daily, capsule
干预措施: Statins (Drug)
结局指标
主要结局
Percent change in Non-HDL-C from baseline to Week 12
时间窗: from baseline to Week 12
次要结局
- Change in HbA1c from baseline to Week 12(from baseline to Week 12)
- Change in Lp-PLA2 from baseline to Week 12(from baseline to Week 12)
- Change in ApoB from baseline to Week 12(from baseline to Week 12)
- Change in triglycerides from baseline to Week 12(from baseline to Week 12)
- Change in VLDL-C from baseline to Week 12(from baseline to Week 12)
- Change in total cholesterol from baseline to Week 12(from baseline to Week 12)
- Change in ApoA1 from baseline to Week 12(from baseline to Week 12)
- Change in HDL-C from baseline to Week 12(from baseline to Week 12)
- Change in LDL-C from baseline to Week 12(from baseline to Week 12)
- Change in fasting plasma glucose from baseline to Week 12(from baseline to Week 12)
- Change in hsCRP from baseline to Week 12(from baseline to Week 12)
- Change in insulin from baseline to Week 12(from baseline to Week 12)
- Change in red blood cell content of EPA and DHA from baseline to Week 12(from baseline to Week 12)
- Change in Insulin Resistance (HOMA) from baseline to Week 12(from baseline to Week 12)
研究者
研究点 (29)
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