A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Clinical Trial

Official title: A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Status Terminated

Clinical Trial Summary

The endothelin receptor antagonist macitentan showed significant improvement compared with placebo in pulmonary vascular resistance (PVR) and 6-minute walking distance (6MWD) in inoperable CTEPH patients in the phase II MERIT-1 trial (AC-055E201, NCT02021292). However, in the MERIT-1 trial Japanese patients were not included. Therefore, in line with Japan's medical environment, this phase III study is to confirm the efficacy and safety of macitentan in Japanese CTEPH patients.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
• Hypertension
• Hypertension, Pulmonary

• NCT number: NCT03809650
• Study type: Interventional
• Source: Actelion
• Status: Terminated
• Phase: Phase 3
• Start date: January 8, 2019
• Completion date: June 29, 2020