NCT00689442已完成2 期
A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Atorvastatin 20 mg in Patients With Low HDL Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- % change from baseline in HDL-C; inhibition of CETP activity
研究概览
简要总结
The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with low HDL
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having lipid values as indicated below:
- •HDL-C ≤ 1.0 mmol/L (40 mg/dL)
- •TG ≤4.5 mmol/L (400 mg/dL)
- •Patients with CHD or CHD risk equivalent
- •Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)
排除标准
- •Body Mass Index of ≥ 35 kg/m2
- •Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
- •Concomitant use of medications identified in the protocol
研究组 & 干预措施
1
Experimental
JTT-705 600 mg and atorvastatin 20 mg
干预措施: JTT-705 600 mg and atorvastatin 20 mg (Drug)
2
Placebo Comparator
Placebo and atorvastatin 20 mg
干预措施: Placebo and atorvastatin 20 mg (Drug)
结局指标
主要结局
% change from baseline in HDL-C; inhibition of CETP activity
时间窗: 4-weeks
次要结局
- % change from baseline in LDL-C and TC/HDL-C(4-weeks)
- Plasma concentration of JTT-705(4-weeks)
研究者
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