NCT00754507已完成4 期
Efficacy of WelChol as an Add-on to Atorvastatin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.
研究概览
简要总结
To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female > or greater than 18 years of age
- •On a stable dose of atorvastatin
- •LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
- •TG < or = to 300 mg/dL
- •Women are not pregnant or breast-feeding or planning to become pregnant
- •Women of child-bearing potential had a hysterectomy or tubal-ligation, or
- •women were post menopausal, or
- •women practiced an acceptable method of contraception as specified in the protocol
排除标准
- •BMI > 40 kg/m2
- •History of allergic or toxic reaction to colesevelam HCl
- •History of swallowing disorders
- •Any serious disorder that could impact the conduct of the study
- •History of drug or alcohol abuse
研究组 & 干预措施
1
Experimental
colesevelam tablets and atorvastatin tablets
干预措施: colesevelam HCl tablets, and atorvastatin tablets (Drug)
2
Placebo Comparator
colesevelam HCl placebo tablets and atorvastatin tablets
干预措施: colesevelam HCl placebo tablets and atorvastatin tablets (Drug)
结局指标
主要结局
The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint.
时间窗: 6 weeks
次要结局
- The absolute change in LDL-C from baseline to endpoint(6 weeks)
- The absolute change and % change in total cholesterol(6 Weeks)
- The absolute change and % change in C-reactive protein(6 weeks)
- The absolute change and % change in triglycerides(6 Weeks)
- The absolute change and % change in HDL-C(6 Weeks)
研究者
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