A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety
Summary
The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.
Timeline
- Start
- 2018-06-18
- Primary completion
- 2021-05-14
- Completion
- 2022-04-25
Outcome
Met primary endpoint
registry analysis (superiority test); Aprocitentan 12.5 mg in Part 1 (Double-blind) vs Placebo in Part 1 (Double-blind); p = 0.0042; LS Mean difference to placebo -3.79 (97.5% CI -6.76 to -0.82) NCT03541174 ↗
registry analysis (superiority test); Aprocitentan 25 mg in Part 1 (Double-blind) vs Placebo in Part 1 (Double-blind); p = 0.0046; LS Mean difference to placebo -3.73 (97.5% CI -6.67 to -0.78) NCT03541174 ↗
release “Primary and key secondary endpoints were met with statistical significance and clinically meaningful results” idorsia.com ↗
release “The PRECISION study met its primary efficacy endpoint” jnj.com ↗
release “In PRECISION, aprocitentan was well tolerated and superior to placebo in lowering blood pressure at week 4” idorsia.com ↗
release “Key PRECISION findings1,5 Doses of aprocitentan 12.5 and 25 mg showed a statistically significant reduction vs placebo on SiSBP at Week 4.” idorsia.com ↗
release “Doses of aprocitentan 12.5 and 25 mg showed a statistically significant reduction vs placebo on SiSBP at Week 4.” idorsia.com ↗
Publications
- Background Daskalopoulou SS, Khan NA, Quinn RR, Ruzicka M, McKay DW, Hackam DG, Rabkin SW, Rabi DM, Gilbert RE, Padwal RS, Dawes M, Touyz RM, Campbell TS, Cloutier L, Grover S, Honos G, Herman RJ, Schiffrin EL, Bolli P, Wilson T, Feldman RD, Lindsay MP, Hemmelgarn BR, Hill MD, Gelfer M, Burns KD, Vallee M, Prasad GV, Lebel M, McLean D, Arnold JM, Moe GW, Howlett JG, Boulanger JM, Larochelle P, Leiter LA, Jones C, Ogilvie RI, Woo V, Kaczorowski J, Trudeau L, Bacon SL, Petrella RJ, Milot A, Stone JA, Drouin D, Lamarre-Cliche M, Godwin M, Tremblay G, Hamet P, Fodor G, Carruthers SG, Pylypchuk G, Burgess E, Lewanczuk R, Dresser GK, Penner B, Hegele RA, McFarlane PA, Sharma M, Campbell NR, Reid D, Poirier L, Tobe SW; Canadian Hypertension Education Program. The 2012 Canadian hypertension education program recommendations for the management of hypertension: blood pressure measurement, diagnosis, assessment of risk, and therapy. Can J Cardiol. 2012 May;28(3):270-87. doi: 10.1016/j.cjca.2012.02.018.
- Background Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6.
- Results Danaietash P, Verweij P, Wang JG, Dresser G, Kantola I, Lawrence MK, Narkiewicz K, Schlaich M, Bellet M; PRECISION investigators. Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan. J Clin Hypertens (Greenwich). 2022 Jul;24(7):804-813. doi: 10.1111/jch.14517. Epub 2022 Jun 9.
- Valdes PO, Pickard B, Orakwue C, Ferdinand K. Aprocitentan: An oral, once-daily antihypertensive therapy for resistant hypertension in adult patients. Heart Int. 2026 Feb 10;20(1):35-39. doi: 10.17925/HI.2026.20.1.1. eCollection 2026.
- Rossignol P, Clozel M, Dreier RF, Flack JM, Flamion B, Mann J, Narkiewicz K, Sassi-Sayadi M, Wang JG, Weber MA, Schlaich MP. Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension. Hypertension. 2026 Feb;83(2):e25563. doi: 10.1161/HYPERTENSIONAHA.125.25563. Epub 2025 Dec 9.
- Flack JM, Schlaich MP, Weber MA, Sassi-Sayadi M, Narkiewicz K, Clozel M, Dreier RF, Andrawis NS, Danaietash P, Gabra N, Scott D, Wang JG, Ferdinand KC. Aprocitentan for Blood Pressure Reduction in Black Patients. Hypertension. 2025 Apr;82(4):601-610. doi: 10.1161/HYPERTENSIONAHA.124.24142. Epub 2025 Jan 22.
- Xu J, Jiang X, Xu S. Aprocitentan, a dual endothelin-1 (ET-1) antagonist for treating resistant hypertension: Mechanism of action and therapeutic potential. Drug Discov Today. 2023 Nov;28(11):103788. doi: 10.1016/j.drudis.2023.103788. Epub 2023 Sep 22.
- Schlaich MP, Bellet M, Weber MA, Danaietash P, Bakris GL, Flack JM, Dreier RF, Sassi-Sayadi M, Haskell LP, Narkiewicz K, Wang JG; PRECISION investigators. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial. Lancet. 2022 Dec 3;400(10367):1927-1937. doi: 10.1016/S0140-6736(22)02034-7. Epub 2022 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprocitentan | Small molecule | 12.5 mg | Oral |
| Subject | Aprocitentan | Small molecule | 25 mg | Oral |