Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03809650
Status:
TERMINATED
Last Update Posted:
2021-06-18
First Post:
2019-01-10
Brief Title:
A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension CTEPH
Sponsor:
Actelion
Organization:
Actelion
Study Overview
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
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to a change in the development strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Japans medical environment this phase III study is to confirm the efficacy and safety of macitentan in Japanese CTEPH patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None