A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 and Simvastatin Combination Therapy to ABT-335 and Simvastatin Monotherapy in Subjects With Mixed Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 657
- 试验地点
- 1
- 主要终点
- Mean Percent Change in Triglycerides From Baseline to Final Visit
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335) + simvastatin combination therapy with ABT-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects with mixed dyslipidemia
- •Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.
排除标准
- •Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
- •Patients who are taking certain medications or unstable dose of specific medications.
- •Women who are pregnant or plan on becoming pregnant, or women who are lactating.
研究组 & 干预措施
A
ABT-335 + 20 mg simvastatin
干预措施: ABT-335 (Drug)
A
ABT-335 + 20 mg simvastatin
干预措施: Simvastatin (Drug)
B
ABT-335 + 40 mg simvastatin
干预措施: ABT-335 (Drug)
B
ABT-335 + 40 mg simvastatin
干预措施: Simvastatin (Drug)
C
ABT-335 monotherapy
干预措施: ABT-335 (Drug)
C
ABT-335 monotherapy
干预措施: Placebo (Drug)
D
20 mg simvastatin monotherapy
干预措施: Simvastatin (Drug)
D
20 mg simvastatin monotherapy
干预措施: Placebo (Drug)
E
40 mg simvastatin monotherapy
干预措施: Simvastatin (Drug)
E
40 mg simvastatin monotherapy
干预措施: Placebo (Drug)
F
80 mg simvastatin monotherapy
干预措施: Simvastatin (Drug)
F
80 mg simvastatin monotherapy
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Percent Change in Triglycerides From Baseline to Final Visit
时间窗: Baseline to 12 Weeks (Final Visit)
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
时间窗: Baseline to 12 Weeks (Final Visit)
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit
时间窗: Baseline to 12 Weeks (Final Visit)
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
次要结局
- Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit(Baseline to 12 Weeks (Final Visit))
- Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C)From Baseline to Final Visit(Baseline to 12 Weeks (Final Visit))
- Mean Percent Change in Total Cholesterol From Baseline to Final Visit(Baseline to 12 Weeks (Final Visit))
- Mean Percent Change in Lipoprotein Apo B (Apo B) From Baseline to Final Visit(Baseline to 12 Weeks (Final Visit))
- Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Final Visit(Baseline to 12 Weeks (Final Visit))