NCT00300430已完成3 期
A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed 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
- 1,911
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
研究概览
简要总结
The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with 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
- None
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
- •Adult male and female subjects who voluntarily sign the informed consent.
- •Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.
排除标准
- •Subject is using or will use investigational medications, except as approved by Abbott.
- •Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.
研究组 & 干预措施
A
Active Comparator
20 mg drug and ABT-335
干预措施: ABT-335 and rosuvastatin calcium (Drug)
B
Active Comparator
40 mg drug and ABT 335
干预措施: ABT-335 and atorvastatin calcium (Drug)
C
Active Comparator
40 mg drug and ABT-335
干预措施: ABT-335 and simvastatin (Drug)
结局指标
主要结局
Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study
时间窗: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy
次要结局
- Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
- Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
- Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
- Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study(Baseline to Week 52 in this open-label study)
- Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
- Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
- Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
- Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study(Baseline to Week 52 of the open-label study)
研究者
研究点 (1)
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