HypercholesterolemiaNCT05000541
Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical
An observational study of Hypercholesterolemia, run by Mylan Inc. at 7 sites in 2 countries.
Trial summary
The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 259 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 8 Dec 2020to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects to be enrolled are subjects already in primary prevention for CVD for raised LDL-C and who, according to the intervention strategies recommended in Table 5 of the ESC/EAS guidelines (lifestyle interventions, consider drug if uncontrolled) had been prescribed, in the previous 3 months, only dietary advices and physical exercise.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany5 sites
Medical Practice
Bexbach, 66450
Medical Practice
Deggingen, 73326
Medical Practice
Frankfurt, 60598
Medical Practice
Görlitz, 02827
AmBeNet GmbH
Leipzig, 04107
About this study
Official title: 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
The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical.
Read the detailed 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.
- Conditions
- Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Armolipid-L/Armolipid Plus-L | Armolipid-L used for participants in Germany and Poland Armolipid Plus-L used for participants in Austria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in LDL-C
Mean change from baseline in LDL-C at 3 months
Measured: 3 months
Secondary outcomes (1)
Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS)
Subjects' adherence (at 3 months and 6 months) to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS); minimum 0mm, maximum 100mm; higher value means better adherence
Measured: at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start8 Dec 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mylan Österreich GmbH, Mylan Germany GmbH, Mylan Healthcare Sp. z o.o.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000541
- Sponsor's protocol ID
- 3319
- Status last verified
- Apr 2023
- First submitted
- 4 Aug 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05000541
- Acronym / sponsor ID
- 3319
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mylan Österreich GmbH, Mylan Germany GmbH, Mylan Healthcare Sp. z o.o.
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present multinational, multicentre, prospective, scientific study is to confirm that prescription of a low-dose red yeast-based nutraceutical.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Armolipid-L/Armolipid Plus-L | – | –Armolipid-L used for participants in Germany and Poland Armolipid Plus-L used for participants in Austria |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects to be enrolled are subjects already in primary prevention for CVD for raised LDL-C and who, according to the intervention strategies recommended in Table 5 of the ESC/EAS guidelines (lifestyle interventions, consider drug if uncontrolled) had been prescribed, in the previous 3 months, only dietary advices and physical exercise.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean change from baseline in LDL-C
Time frame: 3 months
Mean change from baseline in LDL-C at 3 months
1 secondary outcome
Subjects' adherence to the prescribed lifestyle interventions measured on Visual Analogue Scale (VAS)
Time frame: at 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Mylan Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in LDL-C (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.