JPRN-jRCT1080223267未知未知
Exploratory study of the effects of omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 53 人开始时间: 2016年7月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 53
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 diagnosed as hyperlipidemia.
- •2.Patients constantly receiving a HMG-CoA reductase inhibitor at a stable dose for at least 4 weeks at the time of informed consent.
- •3.Patients with fasting TG of 150=< to <400 mg/dL measured at the time of informed consent at Visit 1 (Week -4).
- •4.Patients who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.
- •5.Patients who can provide written informed consent prior to the conduction of the clinical study procedures.
- •6.Patients aged >=20 years at the time of informed consent at Visit 1 (Week -4).
排除标准
- •1.Patients who 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, or those who concurrently have the above disorders.
- •2.Patients who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24 weeks prior to informed consent, those who concurrently have the above disorders, or those who are orally receiving a therapeutic drug for thyroid disorder.
- •3.Patients in whom the type of HMG-CoA reductase inhibitors was changed within 12 weeks prior to informed consent.
- •4.Patients who received an EPA preparation or an EPA/DHA preparation (including supplements) within 12 weeks prior to informed consent.
- •5.Patients who started antidyslipidemic agents within 4 weeks prior to informed consent.
- •6.Patients with severe hepatic impairment (e.g., Child-Pugh classification C)
- •7.Patients who were previously diagnosed as lipoprotein lipase deficiency or apoprotein C-II deficiency.
- •8.Patients who are concurrently having Cushing's syndrome, uremia, systemic lupus erythematosus (SLE), or serum dysproteinemia.
- •9.Diabetic patients who are currently receiving thiazolidine or insulin.
- •10.Patients who are concurrently having hypertension of grade III.
- •Note 1: Patients with systolic blood pressure of >=180 mm Hg or diastolic blood pressure of >=110 mm Hg regardless of treatment with antihypertensive drugs.
- •11.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.
- •12.Pregnant, lactating or postmenopausal women.
- •13.Patients with a history of hypersensitivity or allergy for omega-3-acid ethyl esters.
- •14.Patients participating in other clinical studies
- •15.Patients assessed ineligible in the study by the principal investigator or the investigator
研究者
相似试验
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 dilatioHyperlipidemiaJPRN-jRCT1080223214TAKEDA PHARMACEUTICAL COMPANY LTD.37
已完成
4 期
Investigation of the effects of omega-3 on immune system in patients with thyroid cancer under the treatment with radioiodinecancerIRCT20220104053622N1ational Institute for Medical Research Development90
已完成
不适用
Elucidation of the effect of Omega-3-Acid ethyl esters for CKD patients with dyslipidemia, compared to ethyl icosapentateJPRN-UMIN000013149Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine100
已完成
3 期
Effect of Omega-3 fatty acids on premenstrual syndromePremenstrual syndrome.Premenstrual tension syndromeIRCT138808122624N2Investigator123
已完成
2 期
The effects of omega-3 fatty acids supplementation on type 2 diabetes mellitusIRCT2017092724081N3Vice chancellor for research, Tehran University of Medical Sciences20