NCT04385589 - 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)

Cappetta D, De Angelis A, Ciuffreda LP, Coppini R, Cozzolino A, Miccichè A, Dell'Aversana C, D'Amario D, Cianflone E, Scavone C, Santini L, Palandri C, Naviglio S, Crea F, Rota M, Altucci L, Rossi F, Capuano A, Urbanek K, Berrino L
Amelioration of diastolic dysfunction by dapagliflozin in a non-diabetic model involves coronary endothelium. Pharmacol Res. 2020 Jul;157:104781. doi: 10.1016/j.phrs.2020.104781. Epub 2020 Apr 28.
Elsisi GH, Anwar MM, Khattab M, Elebrashy I, Wafa A, Elhadad H, Awad M, Carapinha JL
Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt. J Med Econ. 2020 Aug;23(8):908-914. doi: 10.1080/13696998.2020.1764571. Epub 2020 May 28.
Linden K, Mailey J, Kearney A, Menown IBA
Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials. Adv Ther. 2020 Jun;37(6):2620-2645. doi: 10.1007/s12325-020-01355-5. Epub 2020 May 2. Review.
Ohara K, Masuda T, Morinari M, Okada M, Miki A, Nakagawa S, Murakami T, Oka K, Asakura M, Miyazawa Y, Maeshima A, Akimoto T, Saito O, Nagata D
The extracellular volume status predicts body fluid response to SGLT2 inhibitor dapagliflozin in diabetic kidney disease. Diabetol Metab Syndr. 2020 May 1;12:37. doi: 10.1186/s13098-020-00545-z. eCollection 2020.

Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF)

Details for clinical trial NCT04385589

Clinical trial NCT04385589 - References