EUCTR2005-005347-25-DE进行中（未招募）不适用
Impact of 12 weeks of oral niacin on endothelial function, lipid composition and cardiovascular biomarkers in patients with coronary artery disease: A prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV - INEF
Johannes Gutenberg-Universität Mainz, II. Med. Klinik (ausführende Stelle), Prof. Dr. med. T. Münzel0 个研究点目标入组 130 人开始时间: 2006年1月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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
- •-Men or women > 35 and < 80 years of age
- •-Documented clinically stable CAD and known dyslipidemia, defined by a LDL-Cholesterol >70 mg/dl and a HDL-Cholesterol <65mg/dl.
- •-A flow-mediated vasodilatation (FMD) of less than 8%
- •-Ability of subject to understand character and individual consequences of clinical trial
- •-Written informed consent must be available before enrollment in the trial
- •-For women with childbearing potential, adequate contraception.
- •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
- •-Clinical signs of congestive heart failure or left ventricular ejection fraction <30%
- •-Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <90 mmHg)
- •-Initiation of any of the following medications within the last twelve weeks: Aspirin, lipid-lowering agents; calcium antagonists;betablockers, ACE-inhibitors or AT1 receptor blockers; hormone replacement therapy
- •-Use of steroids or chemotherapy drugs within the past year or chronic use of nonsteroidal anti-inflammatory drugs except of aspirin
- •-Hemodynamically significant valvular heart disease or hypertrophic obstructive cardiomyopathy
- •-Renal dysfunction (creatinine > 2.5 mg/dl)
- •-Known hepatic disease or elevation of serum transaminases or gGT > 2x ULN (upper limit of normal range)
- •-Uric acid >10,0 mg/dl
- •-Alcohol abuse
- •-WBC >12.000 or platelet count >500.000/µl or <75.000/µl
- •-Existence of acute gastric ulcers
- •-Existence of acute arterial bleeding
- •-Other significant laboratory abnormalities that the investigator feels may compromise the patient’s safety by participation in the study
- •-History of systemic inflammatory disease (rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, systemic lupus erythematous), myositis/myopathic process, or cancer
- •-Known HIV
- •-Malabsorption
- •-Overt hyperthyreodism
- •-Pregnancy and lactation
- •-History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- •-Participation in other clinical trials and observation period of competing trials, respectively
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