NCT02603809

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

A Multi-center, Double-blind, Double-dummy, Randomized, Placebo- and Active-reference, Parallel Group, Phase 2, Dose-finding Study With ACT-132577 in Subjects With Essential Hypertension (Grade 1 and 2).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,659 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participation in the study is planned to last up to 18 weeks. A single-blind placebo run-in period of 4 to 6 weeks after which participants will be randomized into a double-blind treatment period of 8 weeks and a washout and follow-up period ending with an end-of-study visit approximately 12 weeks after randomization.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Aprocitentan 5 mg	One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
DRUG	Aprocitentan 10 mg	Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.
DRUG	Aprocitentan 25 mg	One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
DRUG	Aprocitentan 50 mg	One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
DRUG	Lisinopril 20 mg	One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan
DRUG	Placebo	One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.

Timeline

• Start date: 2015-12-14
• Primary completion: 2017-02-28
• Completion: 2017-04-07
• First posted: 2015-11-13
• Last updated: 2022-11-23
• Results posted: 2020-04-13

Locations

90 sites across 4 countries: United States, Canada, Israel, Puerto Rico

Regulatory

• FDA-regulated drug study