EUCTR2006-005747-29-FR进行中（未招募）1 期
Evaluation of the relationship between HDL quantity and HDL functionality in patients treated with HDL-C raising drugs - HDL functionality
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1. Male and post-menopausal female, lipid treatment naïve or previously treated patients
- •2. Age 18 - 75 years (inclusive)
- •3. Low < 40 mg/dL and normal HDL-C levels (between 40 and 59 mg/dL)
- •4. LDL-C levels: >130 mg/dL, but < 190 mg/dL
- •5. Triglyceride levels: >150 mg/dL, but <400 mg/dL
- •6. Written informed consent (approved by the Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
- •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
- •1. Subjects with secondary causes for Dyslipidemia (i.e. diabetes mellitus, hypothyroidism, obstructive liver disease, chronic renal failure)
- •2. Body Mass Index (BMI) = 30 kg/m2
- •3. Patients requiring drugs that increase LDL-C and decrease HDL-C [progestins, anabolic steroids, and corticosteroids]
- •4. Patients who drink alcohol excessively, defined as more than 21 units/week for males and more than 14 units/week for females. An alcohol unit is defined as 10 mL of absolute alcohol, 300 mL beer, 25 mL of a single spirit, or 100 mL of
- •5. History of or current alcohol or drug abuse
- •6. Use of an investigational drug in the 3 months prior to the screening visit
- •7. Any clinically significant medical condition that could interfere with the conduct of the study
- •8. Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg at the screening visit
- •9. History of obstructive biliary disorders, pancreatitis, collagen diseases, or auto-immune diseases
- •10. History of malignancy during the 3 years prior to the screening visit
- •11. Known or suspected diagnosis of hepatitis or human immunodeficiency virus (HIV) infection
- •12. Known thyroid dysfunction
- •13. Any past history of cerebro-vascular accident or coronary events, including unstable angina, myocardial infarction, angioplasty, or coronary artery bypass graft
- •14. Females who are pregnant or breast feeding and females of child bearing potential
- •15. Clinically significant hepatic, renal or cerebral disease
- •16. Hepatic transaminases or creatine phosphokinase > 2 times the upper limit of normal (ULN) at the screening visit
- •17. Unable or unwilling to comply with the protocol requirements, or deemed by the investigator to be unfit for the study
- •18. Subjects contraindicated for PPAR-a or slow release niacin treatment according to approved label
- •19. Lipid modifying drugs
- •20. Any concomitant therapy known to alter any of the parameters to assess (i.e., aspirin, except when aspirin is indicated for the prevention of severe flushes induced by Niaspan)
- •21. Hypersensitivity to PPARa or slow release niacin
研究者
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