Hyperlipidemia Clinical Trial
— PINOfficial 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
Verified date | March 2013 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: National Institute of Health |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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12 months) withdrawn of a statin due to side effects and unwilling to receive treatment with an alternative statin - Class I indication to receive non-pharmacologic intervention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 Exclusion Criteria: • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Sapienza University | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of treatment tolerability | Reasons for treatment discontinuation | Up to 12 months | No |
Secondary | Evaluation of drug effects on lipid and metabolic features | Effects on lipid profile (total cholesterol, LDL cholesterol, triglycerides) and metabolic indexes (glucose levels, HOMA) | Up to 12 months | No |
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