NCT00755352已完成4 期
Efficacy of WelChol as an Add-on to Pravastatin 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
- 67
- 主要终点
- The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.
研究概览
简要总结
Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin 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 = to 18 years of age
- •On a stable dose of pravastatin
- •LDL-C > or = to 100 mg/dL and < or = 250 mg/dL
- •Triglycerides < or = to 300 mg/dL
- •Women are not pregnant or breast-feeding or planning to become pregnant
- •Women have had a hysterectomy or tubal ligation, or who are post-menopausal or who practice an accepted method of birth control 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 disorder
- •Any serious condition that would interfere with the conduct of the study
研究组 & 干预措施
1
Experimental
pravastatin tablets and Welchol tablets
干预措施: pravastatin tablets and Welchol tablets (Drug)
2
Placebo Comparator
pravastatin tablets and Welchol placebo tablets
干预措施: pravastatin tablets and Welchol placebo tablets (Drug)
结局指标
主要结局
The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.
时间窗: 6 weeks
次要结局
- The absolute change and % change of triglycerides from baseline to endpoint(6 Weeks)
- The absolute change and % change of c-reactive protein from baseline to endpoint(6 weeks)
- The absolute change in LDL-C from baseline to endpoint.(6 weeks)
- The absolute change and % change of HDL-C from baseline to endpoint(6 Weeks)
- The absolute change and % change of total cholesterol from baseline to endpoint(6 Weeks)
研究者
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