NCT00688896已完成2 期
A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
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
- 155
- 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 the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.
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 65 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 less than 1.6 mmol/L (60 mg/dL)
- •TG less than 4.5 mmol/L (400 mg/dL)
- •LDL more than 4.0 mmol/L (160 mg/dL)
- •Patients with CHD or CHD risk equivalent
- •Male and females between 18 and 65 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 pravastatin 40 mg
干预措施: JTT-705 600 mg and pravastatin 40 mg (Drug)
2
Experimental
JTT-705 300 mg and pravastatin 40 mg
干预措施: JTT-705 300 mg and pravastatin 40 mg (Drug)
3
Placebo Comparator
Placebo and pravastatin 40 mg
干预措施: Placebo and pravastatin 40 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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终止
4 期
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