NCT04239950已完成3 期
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia
Mochida Pharmaceutical Company, Ltd.1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2020年5月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ethyl icosapentate in Chinese patients with severe hypertriglyceridemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients whose HbA1c from week -6 to week -4 is 8.0% or higher
- •Patients whose Alanine Aminotransferase (ALT) or Aspartate aminotransferase (AST) from week -6 to week -4 is more than 3 times the upper limit of normal
- •Patients with, or with a history of, angina pectoris or myocardial infarction
- •Patients with a history of percutaneous transluminal coronary angioplasty or coronary artery bypass grafting
- •Patients with familial lipoprotein lipase (LPL) deficiency, familial apolipoprotein C-II (apo C-II) deficiency, or familial type III, IV hyperlipidemia
- •Patients with hypothyroidism, Cushing's syndrome, acromegaly, nephrotic syndrome, chronic renal failure, systemic lupus erythematosus, myeloma, or nonalcoholic steatohepatitis (NASH)
- •Patients with hyperlipidemia induced by drugs (e.g., corticosteroids, beta-blockers, contraceptives, interferons, retinoids, and diuretics)
- •Patients with, or with a history of, alcohol dependence or abuse or patients whose hyperlipidemia is presumed to be primarily caused by alcohol
- •Patients with aortic aneurysm or who have undergone aortic aneurysmectomy within the last 6 months
- •Patients with uncontrollable hypertension (patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg in a sitting position at Visit 1 (Week -4))
- •Patients with, or with a history of, pancreatitis or patients suspected as pancreatitis by examination, etc
- •Patients with a diagnosis of complication of pancreas or bile duct-related neoplastic disease
- •Patients with type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy
- •Patients with any of the following hemorrhagic findings within the last 6 months:
- •Patients with, or with a history of, clinically significant hemorrhagic disease (e.g., cerebral hemorrhage, hemophilia, capillary fragility, gastrointestinal [GI] ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage)
- •Patients with clinically significant bleeding tendency (e.g., menorrhagia, frequent epistaxis)
- •Patients with, or with a history of, severe trauma
- •Patients with a history of surgery requiring blood transfusion
- •Patients who have taken any EPA product
- •Patients who have received a PCSK9 (human proprotein convertase subtilisin/kexin type 9) inhibitor to treat hyperlipidemia
- •Patients who have taken antihyperlipidemic drugs within the last 4 weeks
- •Pregnant, possibly pregnant, or lactating women
- •Patients with a history of hypersensitivity to polyunsaturated fatty acids or gelatin
- •Patients with, or with a history of, malignant tumor
- •Patients with any serious disease, including hepatic, renal, hematologic, respiratory, GI, cardiovascular, psychological, neurologic, metabolic, and electrolyte disorders, or hypersensitivity
- •Patients who have received any other investigational drug within the last 3 months
- •Patients who are judged by the principal (or sub-) investigator to be ineligible as a study subject for any other reason
- •Patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg at Visit 2 (Week -2))
- •Patients who have changed the dosage of antidiabetic drug (except insulin) or who have switched from one drug to another since Visit 1 (Week -4)
- •Patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg at Visit 3 (Week -1)
- •Patients with an HbA1c level of ≥8.0% at Visit 2 (Week -2)
- •Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 2 (Week -2)
- •Patients with a systolic blood pressure of ≥180 mmHg or a diastolic blood pressure of ≥110 mmHg at Visit 4 (Week 0)
- •Patients with an HbA1c level of ≥8.0% at Visit 3 (Week -1)
- •Patients whose ALT or AST is more than 3 times the upper limit of normal at Visit 3 (Week -1)
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo, orally, twice daily after breakfast and dinner for 12 weeks.
干预措施: Placebo (Drug)
Ethyl Icosapentate 1.8g
Experimental
Ethyl Icosapentate 0.9g, orally, twice daily after breakfast and dinner for 12 weeks.
干预措施: Ethyl Icosapentate (Drug)
Ethyl Icosapentate 3.6g
Experimental
Ethyl Icosapentate 1.8g, orally, twice daily after breakfast and dinner for 12 weeks.
干预措施: Ethyl Icosapentate (Drug)
结局指标
主要结局
Percentage of change from baseline in serum triglyceride level at 12 weeks after the start of study drug administration
时间窗: Baseline and 12 weeks
Adverse events after the start of study drug administration
时间窗: 12 weeks
次要结局
- Percentage of change from baseline in serum high-density lipoprotein cholesterol (HDL-C) level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
- Adverse drug reaction after the start of study drug administration(12 weeks)
- Percentage of change from baseline in serum total cholesterol level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
- Percentage of change from baseline in serum low-density lipoprotein cholesterol (LDL-C) level at 12 weeks after the start of study drug administration(Baseline and 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial SpondyloarthritisSpondyloarthritisNCT04285229Eli Lilly and Company147
已完成
1 期
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye DiseaseDry Eye DiseaseNCT05576415Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.9
招募中
3 期
Efficacy and Safety Study of 610 in Patients With Severe AsthmaAsthmaNCT06323213Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.480
进行中（未招募）
2 期
Safety and Efficacy Study of GB001 Recombinant Peptide Spray in Subjects With Mild Recurrent Aphthous UlcersHealthyNCT06429566Zhejiang Echon Biopharm Limited120
已完成
2 期
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase InhibitorAdvanced Breast CancerNCT03312738Novartis Pharmaceuticals159