NCT05000541已完成不适用
Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical , in Subjects With Hypercholesterolemia at Low-moderate Cardiovascular Risk Not Requiring a Drug Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 259
- 试验地点
- 3
- 主要终点
- Mean change from baseline in LDL-C
研究概览
简要总结
The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical.
详细描述
The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical significantly increases the LDL-C lowering effect of guideline-driven lifestyle interventions in subjects with hypercholesterolemia at low-moderate cardiovascular risk not requiring a drug therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 75 years;
- •In primary prevention for low-moderate CV risk, with diet and physical exercise to control raised LDL-C level, for at least 3 months;
- •LDL-C > 100 mg/dL (2.6 mmol/L), < 190 mg/dL (4.9 mmol/L)
- •CV risk SCORE <5% (based on SCORE chart according to figure I for Poland respective figure 2 for Austria and Germany in the ESC/EAS guideline 2019);
- •Triglyceride <400 mg/dL;
- •Advised to use nutraceutical as part of the lifestyle intervention as per guideline and within the product label (i.e. posology as in product label);
- •Written informed consent.
排除标准
- •Subjects being treated or who have been treated for up to 3 months before the start of the study with lipid-lowering drugs or nutraceuticals including functional foods for which lipid-lowering effects are known (e.g. fish oil, sterol-containing yoghurts etc.);
- •Subjects involved in other clinical studies with pharmaceutical products
- •Known laboratory evidence of either liver, muscle, thyroid or kidney dysfunction;
- •Subjects with prior history of cardiovascular events or with high cardiovascular risk equivalents;
- •Uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg);
- •Pregnancy and breastfeeding.
结局指标
主要结局
Mean change from baseline in LDL-C
时间窗: 3 months
Mean change from baseline in LDL-C at 3 months
次要结局
- Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS)(at 3 months and 6 months)
研究者
研究点 (3)
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