EUCTR2004-001580-22-DE进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Patient is at least 18 years of age.
- •Patient has a diagnosis of homozygous sitosterolemia, with a history of plasma sitosterol concentration of >5 mg/dL (0.13 mmol/L).
- •Patient has been on an on-going stable regimen of ezetimibe 10 mg daily for at least 6 months prior to visit 1.
- •Current treatment regimen for sitosterolemia and diet must be stable for at least 4 weeks prior to visit 1 and for the duration of the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient has a condition which might pose a risk to the patient, interfere with participation in the study, or does not meet criteria for this protocol.
- •Patient has clinically significant lab abnormalities prior to visit 2 (ALT, AST, CPK = 3 x ULN, TSH >6 mIU/L).
- •Patient has the following conditions: uncontrolled cardiac arrhythmias, severe/unstable peripheral vascular disease, uncontrolled hypertension, impaired renal function, very poorly controlled Type 1 or Type 2 DM, active or chronic hepatobiliary or hepatic disease, positive for HIV.
- •Patient has the following conditions within 1 month of visit 1: unstable angina pectoris, symptomatic carotid disease, myocardial infarction, coronary artery bypass surgery/other invasive coronary.
- •Patient is on statin AND is treated with, or likely to require treatment with, an agent that has precautions or contraindications to concomitant use with the statin.
- •Patient is taking oral corticosteroids UNLESS patient uses as stable replacement therapy for pituitary/adrenal disease.
- •Patient is on a thiazide diuretic UNLESS treated with a stable regimen for at least 6 weeks prior to visit 1.
- •Patient has ileal bypass surgery within 3 months prior to visit 1.
- •Patient has a condition which might pose a risk to the patient, interfere with participation in the study, or does not meet criteria for this protocol.
- •Patient has clinically significant lab abnormalities prior to visit 2 (ALT, AST, CPK = 3 x ULN, TSH >6 mIU/L).
- •Patient has the following conditions: uncontrolled cardiac arrhythmias, severe/unstable peripheral vascular disease, uncontrolled hypertension, impaired renal function, very poorly controlled Type 1 or Type 2 DM, active or chronic hepatobiliary or hepatic disease, positive for HIV.
- •Patient has the following conditions within 1 month of visit 1: unstable angina pectoris, symptomatic carotid disease, myocardial infarction, coronary artery bypass surgery/other invasive coronary.
- •Patient is on statin AND is treated with, or likely to require treatment with, an agent that has precautions or contraindications to concomitant use with the statin.
- •Patient is taking oral corticosteroids UNLESS patient uses as stable replacement therapy for pituitary/adrenal disease.
- •Patient is on a thiazide diuretic UNLESS treated with a stable regimen for at least 6 weeks prior to visit 1.
- •Patient has ileal bypass surgery within 3 months prior to visit 1.
研究者
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