NCT01349010已完成3 期
A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- TC and LDL-C
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.
详细描述
This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients.
Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing Informed Content Form;
- •Age >= 20 (the age at the time of signing ICF; both gender);
- •hyperlipidemia patients who meet the following criteria:
- •4.14 mmol/L (160mg/dL) =< LDL-C (Serum low density lipoprotein-cholesterol) < 6 mmol/L (232mg/dL)
- •TG (Serum triglycerides) < 4.5 mmol/L (398mg/dL);
- •Framingham: Coronary Heart Disease 2-year risk probabilities < 10%.
排除标准
- •Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
- •Subjects who receive Probucol within 6 months prior to the pre-screening period;
- •Coronary Heart Disease subjects;
- •Subjects being treated with cyclosporine;
- •Subjects with a history of hypersensitivity to Probucol;
- •QTc interval > 450ms (male); QTc interval > 470ms (female);
- •Subjects with impaired hepatic and renal function, who meet any of the following abnormal value:
- •AST >= 100IU/L
- •ALT >= 100IU/L
- •Serum creatinine >= 1.5mg/dL
- •Female subjects who are pregnant, lactating, or who plan to conceive;
- •Subjects who are considered by the investigator to be inappropriate to participate in this trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Arm: Placebo 1 tablet bid. p.o
干预措施: Placebo (Drug)
Probucol
Active Comparator
Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o
干预措施: Probucol (Drug)
结局指标
主要结局
TC and LDL-C
时间窗: 8-week
Changes of TC and LDL-C from the baseline after 8-week treatment;
次要结局
- oxLDL and MCP-1(8-week)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid LevelsHyperlipidemiaNCT02187757PreEmptive Meds, Pvt. Ltd180
招募中
不适用
Efficacy of Probucol Combined with Statins Treatment for Ischemic StrokeIschemic StrokeAtherosclerosis of ArteryLipid DisorderStatinNCT06604117Xuanwu Hospital, Beijing200
已完成
2 期
Safety Study of BMS-770767 in Subjects With HypercholesterolemiaDyslipidemiaNCT01058083Bristol-Myers Squibb81
已完成
3 期
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)HypercholesterolemiaNCT00092651Organon and Co1,398
已完成
3 期
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)HypercholesterolemiaNCT00092664Organon and Co1,104