Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical

Mylan

Status: Completed

Conditions: Hypercholesterolemia

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05000541

3319

Details and patient eligibility

About

The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical.

Full description

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.

Enrollment: 259 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

259 participants in 1 patient group

Armolipid-L/Armolipid Plus-L

Description:

Armolipid-L used for participants in Germany and Poland Armolipid Plus-L used for participants in Austria