HyperlipidemiaPhase 4PINNCT01649986
Nutraceuticals to Improve Lipid Profile in European Countries
A Phase 4 study testing Non-pharmacologic intervention and Nutraceuticals (Armolipid Plus) in people with Hyperlipidemia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Non-pharmacologic intervention and Nutraceuticals (Armolipid Plus)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2017
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Class I indication to receive statin treatment but previous (<12 months) withdrawn of a statin due to side effects and unwilling to receive treatment with an alternative statin
- Class I indication to receive non-pharmacologic intervention and prevention strategies because of hyperlipidemia with 'low risk' classification
- Able to understand and willing to sign the informed CF
Who cannot join
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sapienza University
Rome, 00166
Francesco Pelliccia, MD, +39064997 ext. 123, f.pelliccia@mclink.it
Francesco Pelliccia, MD
About this study
Official title: Additive Effects of Nutraceuticals to Non-pharmacologic Intervention to Improve Lipid Profile in the Real World Clinical Practice in European Countries - The PIN (Portugul Italy Nutraceutical) Study
Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects.
In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed.
Read more
Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions.
The primary objective of this study is twofold:
First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated.
Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.
Read the detailed description
Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects.
In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed.
Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions.
In the real world clinical practice, however, it remains unclear if nutraceuticals yield additive therapeutic effects to non-pharmacologic intervention and prevention strategies in patients in whom statin treatment is not tolerated or is not indicated.
The primary objective of this study is twofold:
First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated.
Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.
Patients will be assigned at the discretion of their own general practitioner to receive for 1 year either non-pharmacologic intervention and prevention strategies or non-pharmacologic intervention and prevention strategies associated with a commercially available nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg).
- Conditions
- Hyperlipidemia
- Being tested
- Non-pharmacologic intervention, Nutraceuticals (Armolipid Plus)
- Keywords
- Hyperlipidemia, Non-pharmacologic prevention
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacologic interventionBehavioural
Also called Hypolipidemic non-pharmacologic intervention
Diet and physical exercise
Nutraceuticals (Armolipid Plus)Drug
Also called Armolipid Plus, Rottapharm, Italy
Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg,
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacologic intervention | Active comparator | Patients assigned by their own general practitioner to have non-pharmacologic intervention and prevention strategies will be given details on lifestyle approaches and dietary strategies Receives: Behavioral: Non-pharmacologic intervention |
| Nutraceuticals | Active comparator | Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, Receives: Drug: Nutraceuticals (Armolipid Plus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment tolerability
Reasons for treatment discontinuation
Measured: Up to 12 months
Secondary outcomes (1)
Evaluation of drug effects on lipid and metabolic features
Effects on lipid profile (total cholesterol, LDL cholesterol, triglycerides) and metabolic indexes (glucose levels, HOMA)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
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 University of Roma La SapienzaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Francesco Pelliccia, MD, Principal investigator, Sapienza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649986
- Sponsor's protocol ID
- 450/2012/D
- Acronym
- PIN
- Status last verified
- Mar 2013
- First submitted
- 20 Jul 2012
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Nutraceuticals to Non-pharmacologic Intervention to Improve Lipid Profile in the Real World Clinical Practice in European Countries - The PIN (Portugul Italy Nutraceutical) Study
- ClinicalTrials.gov ID
- NCT01649986
- Acronym / sponsor ID
- PIN / 450/2012/D
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, Non-pharmacologic prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Jul 2012 (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.
Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects.
In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed.
Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions.
The primary objective of this study is twofold:
First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated.
Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.
Detailed description
Cardiovascular prevention include a class I indication to statins in addition to non-pharmacologic intervention and prevention strategies in patients deemed to be 'high risk' according to current scientific guidelines. In the real world, however, statin treatment is often discontinued due to side effects.
In addition, statins are not indicated in those subjects deemed to be 'low risk', in whom only non-pharmacologic intervention and prevention strategies are currently prescribed.
Along with non-pharmacologic intervention and prevention strategies, newer approaches to reduce cholesterol blood levels currently include nutraceuticals, which are compounds derived from foods with cholesterol lowering actions.
In the real world clinical practice, however, it remains unclear if nutraceuticals yield additive therapeutic effects to non-pharmacologic intervention and prevention strategies in patients in whom statin treatment is not tolerated or is not indicated.
The primary objective of this study is twofold:
First, to prospectively compare in the real world clinical practice the efficacy and tolerability of non-pharmacologic intervention vs. the combination of non-pharmacologic intervention with a nutraceutical-based protocol in patients in whom statin treatment is not tolerated or is not indicated.
Second, to evaluate gender and race/ethnic differences in the hypolipidemic effects of a nutraceutical-based protocol among European countries.
Patients will be assigned at the discretion of their own general practitioner to receive for 1 year either non-pharmacologic intervention and prevention strategies or non-pharmacologic intervention and prevention strategies associated with a commercially available nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacologic intervention | Active comparator | Behavioral: Non-pharmacologic interventionPatients assigned by their own general practitioner to have non-pharmacologic intervention and prevention strategies will be given details on lifestyle approaches and dietary strategies |
| Nutraceuticals | Active comparator | Drug: Nutraceuticals (Armolipid Plus)Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Class I indication to receive statin treatment but previous (<12 months) withdrawn of a statin due to side effects and unwilling to receive treatment with an alternative statin
- Class I indication to receive non-pharmacologic intervention and prevention strategies because of hyperlipidemia with 'low risk' classification
- Able to understand and willing to sign the informed CF
Key exclusion criteria (1 listed)
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
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 |
|---|---|---|
| Non-pharmacologic interventionAlso: Hypolipidemic non-pharmacologic interventionDiet and physical exercise | Behavioural | Non-pharmacologic intervention |
| Nutraceuticals (Armolipid Plus)Also: Armolipid Plus, Rottapharm, ItalyPatients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, | Drug | Nutraceuticals |
Primary outcome
Evaluation of treatment tolerability
Time frame: Up to 12 months
Reasons for treatment discontinuation
1 secondary outcome
Evaluation of drug effects on lipid and metabolic features
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
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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.
Francesco Pelliccia, MD principal investigator
Sapienza University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-pharmacologic intervention and Nutraceuticals (Armolipid Plus) in people with Hyperlipidemia, run by University of Roma La Sapienza 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 1 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 7 Mar 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of treatment tolerability (time frame: Up to 12 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 Mar 2013.