A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 68
- 主要终点
- Percent change from baseline to 12 weeks of treatment in Triglycerides
研究概览
简要总结
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mixed dyslipidemia.
排除标准
- •Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
- •Pregnant or lactating women
- •Contra-indication to fenofibrate or simvastatin or atorvastatin
- •Unstable or severe cardiac disease
研究组 & 干预措施
1
干预措施: fenofibrate / simvastatin (Drug)
2
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percent change from baseline to 12 weeks of treatment in Triglycerides
时间窗: 12 weeks
Percent change from baseline to 12 weeks of treatment in HDL-C
时间窗: 12 weeks
Percent change from baseline to 12 weeks of treatment in LDL-C
时间窗: 12 weeks
次要结局
- Percent change from baseline to 12 weeks of treatment in Triglycerides(24 weeks)
- Percent change from baseline to 12 weeks of treatment in HDL-C(24 weeks)
- Percent change from baseline to 12 weeks of treatment in LDL-C(24 weeks)