NCT00185107已完成4 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 13
- 主要终点
- The percent change in LDL-C from the start of the study
研究概览
简要总结
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
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
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
- •18-80 years of age, inclusive;
- •A history of primary hypercholesterolemia
排除标准
- •Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
- •Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease
结局指标
主要结局
The percent change in LDL-C from the start of the study
次要结局
- - The absolute change in LDL-C from baseline
- - The percent change in LDL-C from baseline
- - The absolute changes and percent changes in TG, non-HDL-
- C, HDL-C, total cholesterol and other lipid measures
- - The percentages of patients who achieve target levels of LDL-C at the end of the study
研究者
研究点 (13)
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