NCT00080132终止2 期
An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-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
- 50
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 diagnosis of Fredrickson Type I or V HTG
- •be stable on current maximum tolerated triglyceride lowering therapy
- •have a fasting TG level of at least 880 mg/dL (10 mmol/L)
- •be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control
- •must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent
- •meet body weight requirements
排除标准
- •Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.
- •Patients with class 3 or 4 heart failure
- •Uncontrolled hypothyroidism or other uncontrolled endocrine disease
- •Known, clinically significant eye abnormalities, such as cataracts
- •History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1
- •Alkaline phosphatase greater than 2 times ULN
- •Serum creatinine greater than 2.0 mg/dL
- •Liver cirrhosis and severe liver steatosis
- •Clinically significant infection, malignancy, or psychosis
- •Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored
- •Participation in any other investigational study within the last 30 days
- •Breastfeeding or pregnant
- •Current drug or alcohol abuse
- •Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study
- •Unwillingness to comply with study procedures or unwillingness to cooperate fully
研究者
研究点 (17)
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