EUCTR2009-010520-25-FI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
- •1. Understanding of the study procedures, willing to adhere to the study
- •schedules, and agreement to participate in the study by giving written
- •informed consent prior to screening (Visit 1 [Week -8 or Week -6]);
- •2. 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, including 9 days after the last dose of study drug, unless their sexual partner is surgically sterile or they are abstinent. 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). Women of childbearing potential in Denmark cannot use abstinence as a method of avoiding pregnancy and must use one or more of the listed contraceptive methods even if their partner is surgically sterile;
- •3. 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;
- •4. 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 Vis
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.Use after Visit 1 (Week -8 or Week -6) and during the double-blind period of the study (up to Visit 7 [Week 12]) of any non-study, non statin, lipid-altering medications or supplements including:
- •Niacin >200 mg/day;
- •Omega-3 fatty acid medications;
- •Supplements (e.g., flaxseed, fish, or algal oils) or foods enriched with omega-3 fatty acids (consumption of up to 2 servings per week of fish is acceptable);
- •Sterol/stanol products;
- •Dietary fiber supplements, including >2 teaspoons of Metamucil or psyllium-containing supplements per day;
- •Red yeast rice supplements, garlic supplements, or soy isoflavones supplements;
- •Any other medications, herbal products, or dietary supplements with known or potential lipid-altering effects;
- •6.History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening;
- •7.History of acute or chronic pancreatitis;
- •8.History of symptomatic gallstone disease unless treated with cholecystectomy;
- •9.Known nephrotic range (>3 g/day) proteinuria;
- •10.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;
- •11.Known familial lipoprotein lipase impairment or deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III);
- •12.Requirement for peritoneal dialysis or hemodialysis for renal insufficiency;
- •13.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;
- •14.History of bariatric surgery;
- •15.Uncontrolled hypertension: sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg;
- •16.Known to be infected with human immunodeficiency virus (HIV);
- •17.Positive test for hepatitis B surface antigen or hepatitis C antibody at screening (Visit 1 [Week -8 or Week -6]);
- •18.Anticipation of major surgery during the screening or double-blind periods of the study;
- •19.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;
- •20.Ongoing treatment with weight loss drugs (including over the counter);
- •21.Ongoing treatment with HIV-protease inhibitors, cyclophosphamide, or isotretinoin;
- •22.Treatment with tamoxifen, estrogens, or progestins that has not been stable for >=4 weeks prior to screening;
- •23.Routine or anticipated use of all systemic corticosteroids. Use of local, topical, inhalation or nasal corticosteroids is permitted;
- •24.Thyroid-stimulating hormone (TSH) >1.5 x upper limit of normal (ULN), clinical evidence of hyp
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