NCT00966225已完成1 期
An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- To determine a safe and tolerable dose of LIP-01
研究概览
简要总结
The purpose of this study is to determine a safe and tolerable dose of LIP-01
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-75 years
- •Plasma total-cholesterol >5.2 mmol/L (> 200 mg/dL)
- •Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
- •Willingness and ability to sign written informed consent
- •Women of child bearing capacity who agree to use an acceptable form of birth control during the trial [i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation]
排除标准
- •Plasma triglycerides > 4.0 mmol/L (> 354 mg/dL)
- •Plasma LDL ≥ 5.0 mmol/L (≥ 195 mg/dL)
- •Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris)
- •Moderate/high risk of coronary artery/ cardiovascular disease
- •Diabetes mellitus
- •Uncorrected hypothyroidism
- •Other significant metabolic endocrine disease
- •Uncontrolled hypertension (>160 systolic or >100 diastolic)
- •Active liver disease (ALT >2x normal)
- •Significant gastrointestinal disease
- •Acute inflammatory disease
- •Significant kidney disease (calculated by eGFR <60 mL/min)
- •Any other significant medical condition which, in the opinion of the investigator, could compromise patient safety or confound trial results
- •Any significant/relevant surgery within the last year
- •Use of lipid-lowering drugs
- •Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid)
- •Regular use of natural health products or dietary supplements known to affect lipid or lipoprotein levels (omega-3 fatty acids, green tea extracts, guggulipid, psyllium, plant sterols, policosanols). If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.
- •Pregnant or lactating women
- •Known allergy to any ingredient in the study product, including: Coptis chinensis, Ilex kudingcha, microcrystalline cellulose and magnesium stearate
结局指标
主要结局
To determine a safe and tolerable dose of LIP-01
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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