drugset / Trial / NCT01649986

Nutraceuticals to Improve Lipid Profile in European Countries

NCT01649986

Phase 4 Unknown 100 enrolled University of Roma La Sapienza
RandomizedParallel-groupQuadruple-blindTreatment

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. 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.

Timeline

Start
2014-01
Primary completion
2015-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Berberine Traditional medicine (herbal / TCM) 500 mg
Comparator Policosanol Small molecule 10 mg
Comparator red yeast rice Traditional medicine (herbal / TCM) 200 mg

Indications