NCT00639158已完成3 期
A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia
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
- Abbott
- 入组人数
- 543
- 主要终点
- Median Percent Change in Triglycerides From Baseline to Final Visit
研究概览
简要总结
The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) 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
- 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
- •Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL; HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL).
- •Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.
排除标准
- •Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
- •Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
- •Women who are pregnant or plan on becoming pregnant, or women who are lactating.
研究组 & 干预措施
ABT-335 + atorvastatin + ezetimibe
Active Comparator
干预措施: ABT-335 (Drug)
ABT-335 + atorvastatin + ezetimibe
Active Comparator
干预措施: atorvastatin (Drug)
ABT-335 + atorvastatin + ezetimibe
Active Comparator
干预措施: ezetimibe (Drug)
Placebo + atorvastatin + ezetimibe
Placebo Comparator
干预措施: placebo (Drug)
Placebo + atorvastatin + ezetimibe
Placebo Comparator
干预措施: atorvastatin (Drug)
Placebo + atorvastatin + ezetimibe
Placebo Comparator
干预措施: ezetimibe (Drug)
结局指标
主要结局
Median 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
次要结局
- Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
- Mean Percent Change in Apolipoprotein B (apoB) 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))
- 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 Apolipoprotein CIII (apoCIII) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
- Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit(Baseline to 12 weeks (Final Visit))
研究者
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