NCT00092651已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,398
- 主要终点
- Plasma LDL-C
研究概览
简要总结
The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).
详细描述
The duration of treatment is 4 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High cholesterol
排除标准
- •Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.
结局指标
主要结局
Plasma LDL-C
时间窗: From baseline to study end point, defined in this study as the last available postbaseline LDL-C measurement, after 12 weeks of treatment.
次要结局
- Plasma LDL-C, TG and HDL-C. The proportion of patients achieving LDL-C targets. Tolerability.(From baseline to study end point in TC, TG, HDL-C, ratios of direct LDL-C:HDL-C and TC:HDL-C, non-HDL-C, Apo B, Apo A-I, Apo A-II, Apo E, lipoprotein(a), C[1]reactive protein (CRP), and fibrinogen, after 12 weeks of treatment.)
研究者
相似试验
已完成
3 期
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)HypercholesterolemiaNCT00092664Organon and Co1,104
已完成
2 期
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With HypercholesterolemiaHypercholesterolemiaNCT04784442Otsuka Pharmaceutical Co., Ltd.188
终止
3 期
Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With HypercholesterolemiaHypercholesterolemiaNCT00532558Takeda657
已完成
2 期
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin IntoleranceHypercholesterolemiaNCT01751984Esperion Therapeutics, Inc.56
终止
2 期
Efficacy of Lapaquistat Acetate in Subjects With HypercholesterolemiaHypercholesterolemiaNCT00865228Takeda224