Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension

Summary

The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension. Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577.

Timeline

Start

2015-12-14

Primary completion

2017-02-28

Completion

2017-04-07

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Aprocitentan 10 mg; p = 0.0053; LS Mean -4.93 (95% CI -8.68 to -1.17); ANCOVA NCT02603809 ↗

registry analysis (superiority test); Placebo vs Aprocitentan 25 mg; p <.0001; LS Mean -6.99 (95% CI -10.80 to -3.19); ANCOVA NCT02603809 ↗

Publications

• Verweij P, Danaietash P, Flamion B, Menard J, Bellet M. Randomized Dose-Response Study of the New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension. Hypertension. 2020 Apr;75(4):956-965. doi: 10.1161/HYPERTENSIONAHA.119.14504. Epub 2020 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprocitentan	Small molecule	5 mg	Oral
Subject	Aprocitentan	Small molecule	10 mg	Oral
Subject	Aprocitentan	Small molecule	25 mg	Oral
Subject	Aprocitentan	Small molecule	50 mg	Oral
Comparator	LISINOPRIL ANHYDROUS	Small molecule	20 mg	Oral

Indications