NCT00440154已完成2 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled,Ezetimibe-Calibrated, Multicenter Study Evaluating the Safety and Efficacy of Four Doses and Two Dose-Regimens of AVE5530 Over 4 Weeks in Patients With Mild to Moderate Primary Hypercholesterolemia
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
- Sanofi
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Percent change in LDL-C from baseline
研究概览
简要总结
The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.
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
- •Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
- •Male aged ≥ 18 years or postmenopausal women at screening
排除标准
- •Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
- •Patients with type 1 diabetes
- •Presence or history of cancer within the past five years
- •Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
- •Fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
- •Impaired kidney function and active liver disease
- •Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
- •Creatine Kinase > 2xUpper Limit of Normal range
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
oral administration 5 mg breakfast timing
干预措施: AVE5530 (Drug)
2
Experimental
oral administration 25 mg breakfast timing
干预措施: AVE5530 (Drug)
3
Experimental
oral administration 50 mg breakfast timing
干预措施: AVE5530 (Drug)
4
Experimental
oral administration 100 mg breakfast timing
干预措施: AVE5530 (Drug)
5
Experimental
oral administration 25 mg dinner timing
干预措施: AVE5530 (Drug)
6
Placebo Comparator
oral administration
干预措施: placebo (Drug)
7
Active Comparator
oral administration 10mg breakfast timing
干预措施: ezetimibe (Drug)
结局指标
主要结局
Percent change in LDL-C from baseline
时间窗: 4 weeks
次要结局
- Absolute change from in LDL-C levels(4 weeks)
- Percent change in other lipids and lipoprotein fractions from baseline(4 weeks)
研究者
研究点 (1)
Loading locations...
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