NCT00385658已完成4 期
A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
研究概览
简要总结
This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent to participate in the study prior to any study procedures.
- •Male or female subjects, age between 18-75 years inclusive.
- •All women of child bearing potential must have a negative pregnancy test
- •Metabolic Syndrome according to the International Diabetes Federation definition:
- •Low plasma HDL-C (Men < 40 mg/dl ; Women < 50 mg/dl ).
- •Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
- •And one or more of the following criteria:
- •Triglycerides ≥ 150 mg/d.l
- •Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
- •Fasting plasma glucose≥ 100mg/dl.
- •Previously diagnosed type 2 diabetes.
排除标准
- •Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
- •Type 1 diabetes.
- •HbA1c > 9.5%.
- •Unexplained serum creatine phosphokinase > 2 x Upper limit of normal.
- •History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
- •Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
次要结局
- Compared at the end of each treatment period:
- patients reaching target levels of non-HDL-C <130mg/
- LDL subfractions in a subgroup of patients
- LDL-C/HDL-C
- patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
- Triglycerides
研究者
研究点 (2)
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