EUCTR2012-001638-33-CZ进行中（未招募）1 期
Cholesterol 7alpha-hydroxylase polymorphism as a predictor cholesterolemia responsiveness
Institute for Clinical and Experimental Medicine0 个研究点目标入组 66 人开始时间: 2012年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- sex: males and females
- •- age: 18 - 65 years
- •- confirmation of contraception used (in fertile women)
- •- LDL-cholesterol (calculated) > 3 mmol/l
- •- homozygote for -203A or -203C allele of CYP7A1 gene
- •Sub-study in healthy volunteers:
- •- sex: males
- •- age: 18 - 65 years
- •- BMI < 30 kg/m2
- •- total cholesterol > 5 mmol/l
- •- homozygote for -203A or -203C allele of CYP7A1 gene
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- triglyceride > 3 mmol/l
- •- pregnancy, breast-feeding
- •- treatment with hypolipidemic drugs and oral anticoagulants
- •- decompensated diabetes mellitus
- •- insulin treatment
- •- serious thyreopathy
- •- presence of another confirmed serious disease that could endanger or disadvantage the patient if included into the trial
- •- hypersensitivity to colesevelam or any of the excipients
- •- intestine or bile duct obstruction, obstipation
- •Sub-study in healthy volunteers:
- •- triglyceride > 3 mmol/l
- •- presence of confirmed serious disease such as ischemic heart disease, diabetes mellitus, thyreopathy, nephrotic syndrome, dysproteinemia and others that could endanger or disadvantage the subject if included into the trial
- •- alcoholism
- •- mental disorders
- •- hypersensitivity to colesevelam or any of the excipients
- •- intestine or bile duct obstruction, obstipation
研究者
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