drugset / Trial / NCT02603809

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

NCT02603809

Phase 2 Completed 1659 enrolled Idorsia Pharmaceuticals Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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