NCT04749784Unknown不适用
Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Perrigo CSCI
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- LDL-C levels between High Dose IP and placebo
研究概览
简要总结
The main objective of this double-blind, randomised, placebo-controlled study is to assess the benefit and tolerability of Arterin Cholesterol in subjects with elevated lipid levels within a 12-week period of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •18 to 65 years old
- •BMI 25 - 29.9 kg/m2
- •Generally in good health
- •LDL-C level between 3.359-4.884 mmol/L (130-189 mg/dL)
- •Stable body weight for at least 3 months prior to study inclusion (<3 kg weight change) (self-reported)
- •Not smoking, at least 6 months prior to study inclusion and throughout the study
- •Electrocardiogram (ECG) without pathological findings at V1
- •Readiness and ability to comply with study requirements, in particular:
- •to take IP as recommended
- •to avoid the use of any nutritional, medical and further interventional options for reduction/maintenance of lipid levels during the study (other than the IP)
- •to avoid consumption of grapefruit, but otherwise keep the dietary habits
- •to keep the habitual level of physical activity during the study
- •Women of childbearing potential:
- •commitment to use contraception methods
- •negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •Readiness not to participate in another clinical study during this study
排除标准
- •Known allergy or hypersensitivity to the components of the investigational product
- •LDL-C level ≥4.910 mmol/L (≥190 mg/dL)
- •Total cholesterol level ≥7.254 mmol/L (≥280 mg/dL)
- •Triglyceride level ≥2.851 mmol/L (≥250 mg/dL)
- •HDL-C level <1.034 mmol/L (<40 mg/dL)
- •Known genetic hyperlipidemia
- •Known family history of dyslipidemia
- •History and/or presence of clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- •cardiovascular disease/disorder (myocardial infarction, angina pectoris, stroke, heart failure, arrhythmia) within 6 months or requiring percutaneous coronary intervention or coronary artery bypass surgery
- •untreated or non-stabilised thyroid gland disorder
- •untreated or non-stabilised hypertension (regular systolic blood pressure
- •≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- •acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)
- •untreated/non-stabilised diabetes mellitus type 1 or 2
- •acute or chronic psychotic disorder
- •any other relevant serious diseases
- •Deviation of safety laboratory parameter(s) at V1 that is:
- •clinically significant or
- •>2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
- •Regular medication and/or supplementation and/or treatment (including any natural health products) within the last 2 months prior to V1 and during the study, as per investigator judgement:
- •lipid lowering products (known to affect lipid metabolism, platelet function, antioxidant status, etc.), including dietary or health supplements (e.g. omega-3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, soy protein, psyllium seed husk, probiotics/prebiotics)
- •products that can influence cholesterol levels (e.g. corticosteroids, beta blockers, amiodarone, estrogen, anabolic steroids), unless it is long term and stabilised (contraceptives are allowed in case of a stable continuous intake before and during the study)
- •that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.)
- •any other, which could interfere with the results of the study or the safety of the subject
- •Women of childbearing potential: pregnancy or nursing
- •History of or current abuse of drugs, alcohol or medication
- •Participation in another study during the last 30 days prior to V1
- •Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
结局指标
主要结局
LDL-C levels between High Dose IP and placebo
时间窗: 12 weeks
Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline
次要结局
- Difference between combined IP vs. placebo(12 weeks)
- Difference LDL-C levels between Low Dose IP and placebo(12 weeks)
研究者
研究点 (2)
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