A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Reduction in LDL-C
研究概览
简要总结
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.
详细描述
- LDL-C after 12 weeks of treatment
- Safety and tolerability
- Plasma levels of SLx-4090
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-C > or = 100 mg/dL
- •On stable statin therapy for at least 6 weeks
排除标准
- •Coronary heart disease or risk factors for CHD
研究组 & 干预措施
1
SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
干预措施: SLx-4090 (Drug)
1
SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
干预措施: Statin (Drug)
2
SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
干预措施: SLx-4090 (Drug)
2
SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
干预措施: Statin (Drug)
3
Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
干预措施: Placebo (Other)
3
Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
干预措施: Statin (Drug)
结局指标
主要结局
Reduction in LDL-C
时间窗: 12 weeks
次要结局
- Adverse events(12 weeks)