Trials / Terminated
TerminatedNCT03809650
A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | macitentan 10 mg | macitentan 10 mg, film-coated tablet, oral use |
Timeline
- Start date
- 2019-01-08
- Primary completion
- 2020-06-29
- Completion
- 2020-06-29
- First posted
- 2019-01-18
- Last updated
- 2021-06-18
Locations
23 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03809650. Inclusion in this directory is not an endorsement.