EUCTR2009-010520-25-DK进行中（未招募）不适用
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With an Open-Label Extension to Evaluate the Efficacy and Safety of AMR101 in Patients With Fasting Triglyceride Levels =>500 mg/dL and <=2000 mg/dL:The AMR101 MARINE Study - The Marine Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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 >18 years of age;
- •Women may be enrolled if all 3 of the following criteria are met:
- •?They are not pregnant,
- •?They are not breastfeeding, and
- •?They do not plan on becoming pregnant during the study;
- •Women of childbearing potential must have a negative serum pregnancy test at screening (Visit 1 [Week -8 or Week -6]). Note: Women are not considered to be of childbearing potential if they meet 1 of the following criteria as documented by the investigator:
- •?They have had a hysterectomy or tubal ligation prior to signing the informed consent form or
- •?They are post-menopausal, defined as >=1 year since their last menstrual period or have a follicle-stimulating hormone (FSH) level in a menopausal range;
- •Women of childbearing potential must agree to use an effective method of avoiding pregnancy from screening to the end of the study. Effective methods of avoiding pregnancy are contraceptive methods used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap), abstinence, or a sterile sexual partner;
- •Not on lipid-altering therapy at screening or on 1 of the following lipid altering treatment regimens at screening;
- •On statin therapy (with or without ezetimibe). Patients currently on statin therapy (with or without ezetimibe) will be evaluated by the investigator as to whether this therapy can be safely discontinued at screening, or if it should be continued. For the criteria of safe withdrawal of statin therapy at screening, see Appendix B. If statin therapy (with or without ezetimibe) is to be continued, dose(s) must be stable for >=4 weeks prior to the TG baseline qualifying measurements for randomization (i.e., Visit 2 [Week -2]) or
- •On non-statin, lipid-altering medications (niacin >200 mg/day, fibrates, fish oil, other products containing omega-3 fatty acids, or other herbal products or dietary supplements with potential lipid altering effects), either alone or in combination with statin therapy (with or without ezetimibe). Patients currently taking these non-statin, lipid-altering medications must be able to safely discontinue all non-statin, lipid altering therapy at screening. For the criteria of safe withdrawal of non-statin, lipid-altering medications at screening, see Appendix B;
- •Triglyceride levels >=500 mg/dL and <=2000 mg/dL (>=5.6 mmol/L and <=22.6 mmol/L) (based on an average [arithmetic mean] of Visit 2 [Week -2] and Visit 3 [Week -1]). Note: In cases in which a patient’s average TG level from Visit 2 and Visit 3 falls outside the required range for entry into the study, an additional sample for fasting TG measurement can be collected 1 week later at Visit 3.1. If a third sample is collected at Visit 3.1, entry into the study will be based on the average (arithmetic mean) of the values from Visit 3 and Visit 3.1.; and
- •Willingness to maintain stable diet and physical activity level throughout the study.
- •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.Body mass index >45 kg/m2;
- •2.Participation in another clinical trial involving an investigational agent within 30 days prior to screening (Visit 1 [Week -8 or Week -6]);
- •3.Weight change >3 kg between screening (Visit 1 [Week -8 or Week -6]) and Visit 2 (Week -2);
- •4.HbA1c >9.5% at screening (Visit 1 [Week -8 or Week -6]);
- •5.History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening;
- •6.History of acute or chronic pancreatitis;
- •7.History of symptomatic gallstone disease unless treated with cholecystectomy;
- •8.Known nephrotic range (>3 g/day) proteinuria;
- •9.History or evidence of major and clinically significant, hepatic, pulmonary, renal, hematologic, gastrointestinal (including clinically significant malabsorption), endocrine (other than type 1 or type 2 diabetes), immunologic, dermatologic, neurologic, psychiatric, oncologic, or allergic (including drug allergies, but excluding untreated or treated seasonal allergies at the time of dosing) disease that would interfere with the conduct of the study or interpretation of the data;
- •10.Known lipoprotein lipase impairment or deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III);
- •11.Requirement for peritoneal dialysis or hemodialysis for renal insufficiency;
- •12.History of malignancy, except patients who have been disease-free for >5 years, or whose only malignancy has been basal or squamous cell skin carcinoma;
- •13.History of bariatric surgery;
- •14.Uncontrolled hypertension: sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg;
- •15.Known to be infected with human immunodeficiency virus (HIV);
- •16.Positive test for hepatitis B surface antigen or hepatitis C antibody at screening (Visit 1 [Week -8 or Week -6]);
- •17.Anticipation of major surgery during the screening or double-blind periods of the study;
- •18.Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification (e.g., antihypertensive and antidiabetic medications) that has not been stable for >=4 weeks prior to screening;
- •19.Ongoing treatment with weight loss drugs (including over the counter);
- •20.Ongoing treatment with HIV-protease inhibitors, cyclophosphamide, or isotretinoin;
- •21.Treatment with tamoxifen, estrogens, or progestins that has not been stable for >=4 weeks prior to screening;
- •22.Routine or anticipated use of all systemic corticosteroids. Use of local or topical corticosteroids is permitted;
- •23.Thyroid-stimulating hormone (TSH) >1.5 x upper limit of normal (ULN), clinical evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for >=6 weeks prior to screening;
- •24.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x ULN;
- •25.Unexplained creatine kinase concentration >3 × ULN or creatine kinase elevation due to known muscle disease (e.g., polymyositis, mitochondrial dysfunction);
- •26.Blood donation of >=1 pint (0.5 L) within 30 days prior to screening, or plasma donation within 7 days prior to screening (Visit 1 [Week -8 or Week -6]);
- •27.Consumption of >2 alcoholic beverages per day following screening;
- •28.History of illicit drug use within 1 year of screening;
- •29.Any condition or therapy, which, in the opinion of the investigator, might pose a risk to the patient or make participation in the study not in the patien
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