NCT04882293 - 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)

Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS, Kontopoulos AG
Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care. 2002 Jul;25(7):1198-202.
Escobedo-de la Peña J, de Jesús-Pérez R, Schargrodsky H, Champagne B
[Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish.
Harivenkatesh N, David DC, Haribalaji N, Sudhakar MK
Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial. J Cardiovasc Pharmacol Ther. 2014 May;19(3):296-303. doi: 10.1177/1074248413518968. Epub 2014 Feb 10.
Lella M, Indira K
A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia. J Adv Pharm Technol Res. 2013 Jul;4(3):166-70. doi: 10.4103/2231-4040.116778.

Confirmatory Study of the Efficacy and Safety of the Fixed-dose Combination Atorvastatin / Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients With Type 2 Diabetes (T2D) and Dyslipidaemia (DLP).

Details for clinical trial NCT04882293

Clinical trial NCT04882293 - References