EUCTR2006-005710-12-DE进行中（未招募）1 期
Evaluation of the effect of NICOtinic acid (niacin) on elevated Lipoprotein(a) levels (NICOLa Study) - NICOLa
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •-Lp(a) plasma levels > 30 mg/dl as measured twice
- •-Male or female subjects, aged 18 – 75 years
- •-With and without cardiovascular diseases
- •-Triglyceride levels < 400 mg/dl
- •-Cholesterol and triglyceride levels not requiring immediate change in medication
- •-If concurrent statin therapy, stable doses are required prior and during the study
- •-Willingness to follow all study procedures
- •-Written informed consent
- •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
- •-Known hypertriglyceridaemia or fasting triglycerides > 400 mg/dl
- •-Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia
- •-Documented secondary hypercholesterolaemia of any cause
- •-Initiation or dose change of a lipid-modifying drug within the last four weeks
- •-Known hypersensitivity to nicotinic acid or any components or their derivatives
- •-Concurrent treatment with products containing significant amounts of niacin or nicotinamide
- •-Concurrent treatment with an immediate release formulation of nicotinic acid or a nicotinic acid analogue, e.g. supplements
- •-Cardiovascular diseases which are contra-indicated
- •-Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception
- •-History of malignancy within preceding 10 years
- •-Use of disallowed concomitant medication
- •-History of alcohol or drug abuse, or both
- •-Active liver disease or hepatic dysfunction
- •-Known uncontrolled or poorly controlled diabetes
- •-Persistent uncontrolled or untreated hypertension
- •-Unexplained serum creatine phosphokinase (CK) >3 times the ULN in the last 4 weeks before the randomisation visit
- •-History of severe myalgia of unknown origin
- •-Arterial bleeding
- •-Active peptic ulcer
- •-Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- •-Active gout symptoms
- •-Significant renal insufficiency
- •-Planned hospitalizations for diagnostic or surgical procedures within the next 5 months
- •-Known infectious disease such as hepatitis or HIV
- •-Participation in another investigational drug trial within the four weeks prior to study entry
- •-Previous randomisation into this study
- •-Subjects with serious or unstable medical or psychological condition
研究者
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