HyperlipidemiaNCT00654459
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
An observational study of Hyperlipidemia and Endothelial Dysfunction, run by Federico II University at 1 site in Italy.
Trial summary
Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia, Endothelial Dysfunction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to Apr 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: males and females aged between 18 and 70 with hypercholesterolemya
Who may be able to join
- Males and females aged between 18 and 70
- Total cholesterol levels > 220 mg/dl and LDL-Cholesterol > 130 mg/dl;
- Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months
Who cannot join
- Proven intolerance to an Armolipid Plus compound
- Pregnant women, and women planning to conceive
- Patients in therapy with lipid lowering drugs within the previous 6 weeks
- Triglycerides concentration > 500mg/dl were excluded.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of internal medicine University Federico II
Naples, 80131
About this study
Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.
The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)
- Conditions
- Hyperlipidemia, Endothelial Dysfunction
- Being tested
- Mixture of Berberine, Policosanol, Red Yeast, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of Berberine, Policosanol, Red Yeast, PlaceboDietary supplement
Also called Armolipid Plus
A tablet one a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo | |
| B | Not described Receives: Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations.
Measured: 6 weeks
Secondary outcomes (1)
Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Rottapharm
- Investigators
- Serafino Fazio, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654459
- Sponsor's protocol ID
- ARM 02-07
- Status last verified
- Apr 2008
- First submitted
- 2 Apr 2008
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
- ClinicalTrials.gov ID
- NCT00654459
- Acronym / sponsor ID
- ARM 02-07
- Conditions
- Hyperlipidemia, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Rottapharm
- Study start
- Jul 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Apr 2008 (estimated)
- 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.
Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.
The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo |
| B | – | Dietary Supplement: Mixture of Berberine, Policosanol, Red Yeast, Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- males and females aged between 18 and 70 with hypercholesterolemya
Key inclusion criteria (3 listed)
- Males and females aged between 18 and 70
- Total cholesterol levels > 220 mg/dl and LDL-Cholesterol > 130 mg/dl;
- Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months
Key exclusion criteria (4 listed)
- Proven intolerance to an Armolipid Plus compound
- Pregnant women, and women planning to conceive
- Patients in therapy with lipid lowering drugs within the previous 6 weeks
- Triglycerides concentration > 500mg/dl were excluded.
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 |
|---|---|---|
| Mixture of Berberine, Policosanol, Red Yeast, PlaceboAlso: Armolipid PlusA tablet one a day for 6 weeks | Dietary supplement | A, B |
Primary outcome
The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations.
Time frame: 6 weeks
1 secondary outcome
Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.
Time frame: 6 weeks
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 16 Apr 2008.
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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.
Serafino Fazio, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia and Endothelial Dysfunction, run by Federico II University at 1 site in Italy.
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 3 inclusion and 4 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 16 Apr 2008. 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 Italy. 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?
The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations. (time frame: 6 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 16 Apr 2008.