EUCTR2009-010520-25-IT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 schedule, 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; 3. At high risk for cardiovascular disease, i.e., patients with clinical coronary heart disease (CHD) or clinical CHD risk equivalents (10-year risk >20%) as defined in the NCEP ATP III Guidelines 4. On a stable dose of statin therapy (with or without ezetimibe) 5. Triglyceride levels ≥200 mg/dL and <500 mg/dL (based on an average [arithmetic mean] of Visit 2 [Week -2] and Visit 3 [Week -1]). 6. Low-density lipoprotein cholesterol levels ≥40 mg/dL and <100 mg/dL (based on an average [arithmetic mean] of Visit 2 [Week -2] and Visit 3 [Week -1]). 7. 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. BMI >45 kg/m2; 2. Participation in another clinical trial within 30 days prior to screening 3. Weight change >3 kg between screening 4.Mean Non-HDL-C levels <100 mg/dL from the last 2 visits before randomization. 5. Hemoglobin A1c >9.0% at screening 6. Use after Visit 1 and during the study of any non-study drug related, non-statin, lipid-altering medications or supplements 7. Use after Visit 1 and during the study of any statin other than atorvastatin, rosuvastatin or simvastatin. 8. PCI within 4 weeks prior to screening 9. Hospitalization for acute coronary syndrome and discharge within 4 weeks prior to screening 10. Known nephrotic range (>3 g/day) proteinuria 11.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; 12. Known lipoprotein lipase impairment or deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III); 13. Requirement for peritoneal dialysis or hemodialysis 14. 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; 15. History of bariatric surgery; 16. Uncontrolled hypertension 17. Known to be infected with human immunodeficiency virus (HIV); 18. Positive test for hepatitis B surface antigen or hepatitis C antibody at screening 19. Anticipation of major surgery during the screening or double-blind periods of the study; 20. Treatment with chronic prescription pharmacotherapy for metabolic or cardiovascular disease management or risk factor modification that has not been stable for ≥4 weeks prior to screening; 21. Ongoing treatment with weight loss drugs; 22. Ongoing treatment with HIV-protease inhibitors, cyclophosphamide, or isotretinoin; 23. Treatment with tamoxifen, estrogens, or progestins that has not been stable for ≥4 weeks prior to screening; 24. Routine or anticipated use of all systemic corticosteroids. 25. TSH) >1.5 ? upper limit of normal (ULN),clinical evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for ≥6 weeks prior to screening; 26. ALT or AST >2 ? ULN; 27. Unexplained creatine kinase concentration >3 ? ULN or creatine kinase elevation due to known muscle disease 28. Blood donation of ≥1 pint (0.5 L) within 30 days prior to screening, or plasma donation within 7 days prior to screening ; 29. Consumption of >2 alcoholic beverages per day following screening; 30. History of illicit drug use within 1 year of screening; 31. 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 patient s best interest; or 32. Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study.
研究者
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