NCT03535532 - 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)

Denolle T, Chamontin B, Doll G, Fauvel JP, Girerd X, Herpin D, Vaïsse B, Villeneuve F, Halimi JM
[Management of resistant hypertension. Expert consensus statement from the French Society of Hypertension, an affiliate of the French Society of Cardiology]. Presse Med. 2014 Dec;43(12 Pt 1):1325-31. doi: 10.1016/j.lpm.2014.07.016. Epub 2014 Nov 20. French.
Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM
Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.
Lopez D, Luque-Fernandez MA, Steele A, Adler GK, Turchin A, Vaidya A
"Nonfunctional" Adrenal Tumors and the Risk for Incident Diabetes and Cardiovascular Outcomes: A Cohort Study. Ann Intern Med. 2016 Oct 18;165(8):533-542. doi: 10.7326/M16-0547. Epub 2016 Aug 2.
Sim JJ, Bhandari SK, Shi J, Reynolds K, Calhoun DA, Kalantar-Zadeh K, Jacobsen SJ
Comparative risk of renal, cardiovascular, and mortality outcomes in controlled, uncontrolled resistant, and nonresistant hypertension. Kidney Int. 2015 Sep;88(3):622-32. doi: 10.1038/ki.2015.142. Epub 2015 May 6.
Xu T, Xia L, Wang X, Zhang X, Zhong S, Qin L, Zhang X, Zhu Y, Shen Z
Effectiveness of partial adrenalectomy for concomitant hypertension in patients with nonfunctional adrenal adenoma. Int Urol Nephrol. 2015 Jan;47(1):59-67. doi: 10.1007/s11255-014-0841-8. Epub 2014 Oct 11.

Effectiveness Comparison of Medical Treatment and Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients Concomitant With Adrenal Diseases: A Prospective, Multi-Center, Open-Labeled, Randomized Clinical Trial.

Details for clinical trial NCT03535532

Clinical trial NCT03535532 - References