NCT00680017已完成3 期
A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 280
- 试验地点
- 114
- 主要终点
- Median Percent Change in Triglycerides From Baseline to Week 8.
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ABT-335 plus rosuvastatin
Experimental
ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks
干预措施: ABT-335 plus rosuvastatin (Drug)
Rosuvastatin
Active Comparator
Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Median Percent Change in Triglycerides From Baseline to Week 8.
时间窗: Baseline to 8 weeks
Triglycerides were measured in milligrams/deciliter.
次要结局
- Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.(Baseline to 8 weeks)
研究者
研究点 (114)
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