Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03422328
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2018-01-30
Brief Title:
A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
mUlticenter Single-arM Open-laBel Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UMBRELLA
Brief Summary:
The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension PAH and Chronic thromboembolic pulmonary hypertension CTEPH who were previously treated with macitentan in clinical studies
Detailed Description:
The purpose of this study is to provide continued treatment with macitentan to subjects with PAH or CTEPH who participated in parent studies and to continue to accrue long-term safety data The design of this study is widely used in clinical programs to give participants in a clinical study access to an effective study treatment beyond completion of the parent study This is considered the best option to collect long-term safety and tolerability information of macitentan 10 mg and survival status of participants with PAH and CTEPH Parent studystudies refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH and CTEPH NCT00667823 NCT02112487 NCT02310672 NCT02968901 NCT02558231 NCT02382016 NCT02060721 and may be completed before the participants have access to commercial macitentan in their country of residence The parent studies are fully or partially running in countries where no access to commercial macitentan is expected in the near future
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003934-10 | EUDRACT_NUMBER | None | None |