drugset / Trial / NCT02603809
Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension
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
| 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 |