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Home  >  Medical Research Archives  >  Issue 149  > Dose Selection for Clinical Development in the Treatment of Hypertension: The Aprocitentan Case and Lessons from the Past
Published in the Medical Research Archives
Jan 2024 Issue

Dose Selection for Clinical Development in the Treatment of Hypertension: The Aprocitentan Case and Lessons from the Past

Published on Jan 30, 2024

DOI 

Abstract

 

Dose selection plays a critical role in the clinical development of a drug. This current review highlights the lessons learned from previous dose finding studies (DFSs) of antihypertensive drugs and from the recent example of aprocitentan, a novel endothelin receptor antagonist for the treatment of resistant hypertension. Based on these, the authors provide 10 key recommendations for an efficient DFS for a new antihypertensive medication. These recommendations respect critical comments repeatedly made by the U.S. Food and Drug Administration (FDA) Division of Cardiology and Nephrology over the last 5 decades and go beyond the more limited recommendations made in the 2016 Committee for Medicinal Products for Human Use (CHMP) guideline on the development of new antihypertensive medications. The added value of a dose-response modelling approach enriches prior regulatory advice on DFSs.

Author info

Bellet M, Braunstein G, Verweij P, Danaietash P, Iglarz M, Flamion B

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