drugset / Trial / NCT03809650
A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Phase 3
Terminated
9 enrolled
Actelion
EPS Corporation · collabGeneral Laboratory, BML, Inc. · collabImepro Inc. · collabMitsubishi Logistics Corporation · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-01-08
- Primary completion
- 2020-06-29
- Completion
- 2020-06-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Macitentan | Other / unclassified | 10 mg | Oral |