Blood Cholesterol LowersNCT04749784
Effects of Arterin Cholesterol for Reduction of Lipid Levels
A study testing High Dose Arterin Cholesterol and Low Dose Arterin Cholesterol in people with Blood Cholesterol Lowers and LDL-C, run by Perrigo CSCI at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Cholesterol Lowers, LDL-C
- What is being tested?
- High Dose Arterin Cholesterol and Low Dose Arterin Cholesterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- 30 Oct 2020to Jun 2021
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
analyze & realize GmbH
Berlin, 13467
Ralf Uebelhack, MD
About this study
Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels
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.
- Conditions
- Blood Cholesterol Lowers, LDL-C
- Being tested
- High Dose Arterin Cholesterol, Low Dose Arterin Cholesterol, Placebo
- Keywords
- nutritional supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Arterin CholesterolDietary supplement
240mg active ingredient daily
Low Dose Arterin CholesterolDietary supplement
120mg active ingredient daily
PlaceboDietary supplement
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| High dose IP | Experimental | Two tablets IP daily for 12 weeks Receives: Dietary Supplement: High Dose Arterin Cholesterol |
| Low dose IP | Experimental | One tablet IP + one tablet placebo daily for 12 weeks Receives: Dietary Supplement: Low Dose Arterin Cholesterol |
| Placebo | Placebo comparator | Two tablets placebo daily for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C levels between High Dose IP and placebo
Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline
Measured: 12 weeks
Secondary outcomes (14)
Difference LDL-C levels between Low Dose IP and placebo
Difference in change of LDL-C levels between Low Dose IP and placebo at study end compared to baseline
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in LDL-C levels at V3, V4 and V5 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in change in LDL-C levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in TC levels at V3, V4 and V5 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in change in TC levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in TG levels at V3, V4 and V5 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in change in TG levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in HDL-C levels at V3, V4 and V5 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in change in HDL-C levels at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in LDL-C/HDL-C ratio at V3, V4 and V5 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in change in LDL-C/HDL-C ratio at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in SCORE value at V3, V4 and V5 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in change in SCORE value at V3, V4 and V5, each in comparison to V2 between combined IP vs. placebo
Measured: 12 weeks
Difference between combined IP vs. placebo
Difference in global evaluation of benefit by the subject and investigator at study end between combined IP vs. placebo
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start30 Oct 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Cholesterol LowersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perrigo CSCI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, MD, Principal investigator, Analyze & Realize
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749784
- Sponsor's protocol ID
- PERI/002620
- Status last verified
- Feb 2021
- First submitted
- 28 Oct 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled Study to Evaluate the Benefit and Tolerability of Arterin Cholesterol for Reduction of Lipid Levels
- ClinicalTrials.gov ID
- NCT04749784
- Acronym / sponsor ID
- PERI/002620
- Conditions
- Blood Cholesterol Lowers, LDL-C
- Keywords
- nutritional supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Perrigo CSCIIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Feb 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose IP | Experimental | Dietary Supplement: High Dose Arterin CholesterolTwo tablets IP daily for 12 weeks |
| Low dose IP | Experimental | Dietary Supplement: Low Dose Arterin CholesterolOne tablet IP + one tablet placebo daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTwo tablets placebo daily for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose Arterin Cholesterol240mg active ingredient daily | Dietary supplement | High dose IP |
| Low Dose Arterin Cholesterol120mg active ingredient daily | Dietary supplement | Low dose IP |
| PlaceboPlacebo tablet | Dietary supplement | Placebo |
Primary outcome
LDL-C levels between High Dose IP and placebo
Time frame: 12 weeks
Difference in LDL-C levels between High Dose IP and placebo at study end compared to baseline
14 secondary outcomes
Difference LDL-C levels between Low Dose IP and placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Difference between combined IP vs. placebo
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Ralf Uebelhack, MD principal investigator
Analyze & Realize
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose Arterin Cholesterol and Low Dose Arterin Cholesterol in people with Blood Cholesterol Lowers and LDL-C, run by Perrigo CSCI at 1 site in Germany.
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 17 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralf Uebelhack, MD (+49 30/40 00 81 23, ruebelhack@a-r.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C levels between High Dose IP and placebo (time frame: 12 weeks). 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 11 Feb 2021.