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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    250
  • sponsor
    Mylan Inc.
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Updated on 27 October 2022
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Summary

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

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.

Details
Condition Hypercholesterolemia
Clinical Study IdentifierNCT05000541
SponsorMylan Inc.
Last Modified on27 October 2022

Eligibility

 Yes No Not Sure

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
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