Overview

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

Status:
Terminated

Trial end date:
2020-06-29

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Actelion

Collaborators:

EPS Corporation
General Laboratory, BML, Inc.
Imepro Inc.
Mitsubishi Logistics Corporation

Treatments:

Macitentan