CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 730 enrolled
Drug / intervention
Aprocitentan 12.5 mg +2 moredrug
Likely dose
Aprocitentan 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03541174
NCT03541174Phase 3Completed

Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

Idorsia Pharmaceuticals Ltd.·interventional·Posted May 30, 2018·Updated Mar 21, 2023

In Brief

A Phase 3 clinical trial evaluating Aprocitentan 12.5 mg, Aprocitentan 25 mg, and 1 other intervention for Resistant Hypertension. Completed, enrolled 730 participants across 159 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Poland, Russia, Spain, Ukraine, United Kingdom, United States

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 30, 2018
Enrollment StartJun 18, 2018
Primary CompletionMay 14, 2021
Study CompletionApr 25, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.1 years ago

Interventions

Aprocitentan 12.5 mgdrug

Tablet, oral use

Aprocitentan 25 mgdrug

Tablet, oral use

Placebodrug

Matching placebo tablet