NCT00079846终止2 期
Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 12
研究概览
简要总结
The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 8 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to participate in this study, patients must meet all of the following inclusion criteria:
- •be between 8 and 70 years old with a diagnosis of HoFH;
- •be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
- •have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
- •be male or nonpregnant, nonlactating female;
- •give informed consent; and
- •meet body weight and height requirements.
排除标准
- •In order to participate in this study, patients must not meet any of the following exclusion criteria:
- •recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
- •uncontrolled hypothyroidism or other uncontrolled endocrine disease;
- •known, clinically significant eye abnormalities (e.g., cataracts);
- •appropriate serum creatinine phosphokinase levels;
- •history of liver disease or liver enzyme levels above appropriate levels;
- •alkaline phosphatase above appropriate levels;
- •liver cirrhosis and severe liver steatosis;
- •clinically significant infection, malignancy, or psychosis;
- •use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
- •participation in any other investigational study, including device or observational studies, within 30 days;
- •lactating or have a positive serum pregnancy test;
- •history of or current drug or alcohol abuse; or
- •unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator.
研究者
研究点 (12)
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