NCT00754039已完成4 期
The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
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
- 129
- 主要终点
- % change in LDL-C from baseline
研究概览
简要总结
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-70 years of age
- •History of mixed hyperlipidemia
- •Prescribed a Step 1 diet at least 30 days prior to screening
- •Women were not pregnant, breast-feeding, or plan to become pregnant during the study
- •Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
- •Serum LDL-C >/= 115 mg/dL; Serum TG >/= 150 & < 750 mg/dL
排除标准
- •HbA1C > 10%
- •Type 1 diabetes
- •Intolerance to fibrates
- •History of intolerance to colesevelam HCl
- •History of swallowing disorders or intestinal motility disorders
- •Any other disorder that might interfere with the conduct of the study
- •History of drug or alcohol abuse
- •Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)
研究组 & 干预措施
1
Experimental
Welchol + TriCor
干预措施: colesevelam HCl tablets and fenofibrate tablets (Drug)
2
Placebo Comparator
Welchol + placebo
干预措施: fenofibrate tablets and Welchol placebo tablets (Drug)
结局指标
主要结局
% change in LDL-C from baseline
时间窗: 6 weeks
次要结局
- The absolute change in LDL-C from baseline(6 weeks)
- The absolute change and % change in LDL-C from week -8 (untreated)(14 weeks)
- The percentage of patients who achieved target LDL-C(6 Weeks)
研究者
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