NCT00686010已完成2 期
A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
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
- 198
- 试验地点
- 1
- 主要终点
- %change from baseline in HDL-C, Inhibition of CETP activity
研究概览
简要总结
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with of Type II hyperlipidaemia
- •Patients having lipid values as indicated below:
- •HDL-C < 1.6 mmol/l
- •TG < 4.5 mmol/l
- •Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)
排除标准
- •Body Mass Index (BMI) > 35 kg/m²
- •Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
- •Concomitant use of medications identified in the protocol
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
2
Experimental
JTT-705 300mg
干预措施: JTT-705 300mg (Drug)
3
Experimental
JTT-705 600mg
干预措施: JTT-705 600mg (Drug)
4
Experimental
JTT-705 900mg
干预措施: JTT-705 900mg (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 ratio(4-weeks)
研究者
研究点 (1)
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