NCT00748852已完成2 期
An Eight Week, Open-label Extension Study Evaluating the Safety of JTT-302 Administered Once Daily in Subjects With Low HDL-C Levels Who Have Completed the Treatment Phase of Study AT302-U-06-003
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
- 103
- 主要终点
- Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must have successfully completed the 4-week treatment period of study AT302-U-06-003
排除标准
- •Females who are pregnant or lactating, and females of child bearing potential who are not using an effective method of contraception
- •Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol
- •Subjects who cannot follow the prescription and OTC medication restrictions defined in the protocol
- •Flu-shots not permitted during the study, including the follow-up period.
研究组 & 干预措施
1
Experimental
JTT-302, 400 mg
干预措施: JTT-302 (Drug)
结局指标
主要结局
Evaluate the safety profile of JTT-302 when administered for 8 weeks or 12 weeks
时间窗: 12 weeks
次要结局
- Percent change and change from baseline after four, eight or 12 weeks exposure to JTT-302 in Lipid Parameters(4, 8 or 12 weeks)
研究者
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