NCT06045377 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cicero AFG, Fogacci F, Stoian AP, Vrablik M, Al Rasadi K, Banach M, Toth PP, Rizzo M
Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels? Curr Atheroscler Rep. 2021 Aug 4;23(10):57. doi: 10.1007/s11883-021-00955-y.
Cicero AFG, Kennedy C, Knezevic T, Bove M, Georges CMG, Satrauskiene A, Toth PP, Fogacci F
Efficacy and Safety of Armolipid Plus(R): An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials. Nutrients. 2021 Feb 16;13(2):638. doi: 10.3390/nu13020638.
Guardamagna O, Abello F, Baracco V, Stasiowska B, Martino F
The treatment of hypercholesterolemic children: efficacy and safety of a combination of red yeast rice extract and policosanols. Nutr Metab Cardiovasc Dis. 2011 Jun;21(6):424-9. doi: 10.1016/j.numecd.2009.10.015. Epub 2010 Feb 12.
Santini A, Novellino E
Nutraceuticals in hypercholesterolaemia: an overview. Br J Pharmacol. 2017 Jun;174(11):1450-1463. doi: 10.1111/bph.13636. Epub 2016 Oct 29.
Watts GF, Gidding SS, Hegele RA, Raal FJ, Sturm AC, Jones LK, Sarkies MN, Al-Rasadi K, Blom DJ, Daccord M, de Ferranti SD, Folco E, Libby P, Mata P, Nawawi HM, Ramaswami U, Ray KK, Stefanutti C, Yamashita S, Pang J, Thompson GR, Santos RD
International Atherosclerosis Society guidance for implementing best practice in the care of familial hypercholesterolaemia. Nat Rev Cardiol. 2023 Jun 15. doi: 10.1038/s41569-023-00892-0. Online ahead of print.

Effect of a Nutraceutical, Containing Red Yeast Rice and Polycosanols (Armolipid), on Lipid Profile in Children With Moderate and Severe Hypercholesterolemia.

Details for clinical trial NCT06045377

Clinical trial NCT06045377 - References