NCT02368613Unknown2 期
A Clinical Trial for Evaluation of Adequate Dose and Safety of DW-3102 in Hypercholesterolemia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 主要终点
- The change of LDL-C%
研究概览
简要总结
The purpose of this study is to evaluate adequate-dose of DW-3102 in the treatment of hypercholesterolemia patients by conducting phase 2a. 4 groups involving placebo group, each groups are composed by 16, will be participated in this trial.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 19 years old
- •Those who meet the fasting serum lipid levels along table
- •Those who are under 350 mg/dL of TG level when fasting
排除标准
- •The patient of acute arterial disease
- •The patient of severe heart failure(NYHA class III or IV)
- •Within the last 6 months clinically meaningful treatment that requires that arrhythmias or cardiac conduction disorders
- •Uncontrolled hypertension ( systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg or more later)
- •Endocrine or metabolic disease patients known to affect serum lipids or lipoproteins
- •Fibromyalgia, myopathy, rhabdomyolysis, or sudden muscle pain or have in the past, such as statin (HMG CoA reductase inhibitors) in patients with muscle -related adverse drug experience of the system
- •Drug malabsorption by gastrointestinal surgery experience (but simple appendectomy and hernia surgery is excluded) or gastrointestinal disorders ( Crohn's disease , ulcers , acute or chronic pancreatitis , etc. )
- •Patients with history of malignancies including leukemia and lymphoma within the past five years
- •If severe renal impairment or in patients with impaired liver and hematological findings following the same
- •Patients who have participated in another clinical trial within the previous 30 days or Prior to the administration of at least five times the half-life of the active ingredient is not elapsed patient IND
- •Those having a known hypersensitivity to hyperlipidemia treatment
- •Patients with hypersensitivity or allergy to cruciferous plants
- •Patients with a history of drug or alcohol abuse within the last 12 months
- •Female patients of childbearing age
- •In the case of male test subjects , if the spouse does not agree with the use of childbearing age when women work , recognized contraception exclusion criteria presented in Section 15
- •Patient who are inappropriate by investigator's decision
研究组 & 干预措施
placebo group
Placebo Comparator
Placebo
干预措施: DW-3102 (Drug)
test1 group
Active Comparator
DW-3102 125mg
干预措施: DW-3102 (Drug)
test2 group
Active Comparator
DW-3102 250mg
干预措施: DW-3102 (Drug)
test3 group
Active Comparator
DW-3102 500mg
干预措施: DW-3102 (Drug)
结局指标
主要结局
The change of LDL-C%
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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