JPRN-jRCT1080223214未知4 期
Exploratory study of the effect of omega-3-acid ethyl esters on vascular endothelial function in patients with hyperlipidemia by flow mediated dilation
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 37 人开始时间: 2016年5月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients with the diagnosis of hyperlipidemia and receiving instructions for lifestyle improvement
- •2.Patients with a fasting triglyceride (TG) level of 150 -499 mg/dL at Visit 1 after informed consent (Day -29 to Day -1 before start of study drug administration)
- •3.Patients receiving a stable dose of HMG-CoA reductase inhibitor therapy continuously for at least 4 weeks before informed consent at Visit 1 (Day -29 to Day -1 before start of study drug administration)
- •4.Male or postmenopausal female patients
- •5.Patients who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
- •6.Patients who can provide written informed consent prior to the conduction of the clinical research procedures
- •7.Patients aged >=20 years at the time of informed consent at Visit 1(Day -28 to Day 0 before the start of study drug administration)
排除标准
- •1.Patients with a history of revascularization or those have had coronary artery disease (a definitive diagnosis of myocardial infarction, angina) within 24 weeks before informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
- •2.Patients who have undergo aortic aneurysmectomy within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those with concurrent aortic aneurysm
- •3.Patients who have had clinically significant hemorrhagic disorders (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage) within 24 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those who concurrently have the above disorders
- •4.Patient with a fasting FMD level of 0% measured at the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)
- •5.Patients in whom the type and dosage of HMG-CoA reductase inhibitors, antidiabetic drugs and antihypertensive drugs have been changed within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
- •6.Patients who have started anti dyslipidemic agents within 4 weeks prior to informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
- •7.Patients requiring a change in the dose of dyslipidemia therapeutic, antidiabetic, or antihypertensive drugs during the period between informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration) and the start of study drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug administration)
- •8.Patients with severe hepatic dysfunction
- •9.Patients with severe renal dysfunction (as an indicator, CKD category >=G3b, equivalent to an A3)
- •10.Patients who have been diagnosed with pancreatitis
- •11.Patients who have been diagnosed with lipoprotein lipase deficiency, apoprotein C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or familial type III hyperlipidemia
- •12. Patients with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), serum dysproteinemia, or hypothyroidism
- •13. Patients with symptomatic Peripheral Arterial Disease (PAD)
- •14.Patients with concurrent hypertension of grade II or higher Note 1)
- •Note 1: Patients with systolic blood pressure of >=160 mm Hg or diastolic BP of >=100 mm Hg regardless of treatment with antihypertensive drugs
- •15.Patients who are habitual drinkers drinking an average of over 100 mL per day (expressed in terms of quantity of alcohol) or patients with, or with a history of drug abuse or addiction Note 2)
- •16.Patients with a history of hypersensitivity or allergy for omega-3-acid ethyl esters-
- •17.Patients who smoke
- •18.Patients participating in other clinical studies
- •19. Patients who have been determined to be ineligible as subjects in the study by the principal investigator or the investigator
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