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CompletedNCT04565990

A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants Who Participated in a Previous Selexipag Study

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
43 (actual)
Sponsor
Actelion · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to assess the long-term safety of selexipag while providing continued selexipag treatment for participants who were previously enrolled in an Actelion-sponsored study with selexipag and who derived benefit from selexipag in indications for which a positive benefit-risk has been established.

Conditions

Interventions

TypeNameDescription
DRUGSelexipagSelexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.

Timeline

Start date
2021-05-03
Primary completion
2023-11-10
Completion
2023-11-10
First posted
2020-09-28
Last updated
2025-05-01
Results posted
2024-11-20

Locations

13 sites across 6 countries: Belarus, India, Romania, South Korea, Taiwan, Ukraine

Regulatory

Source: ClinicalTrials.gov record NCT04565990. Inclusion in this directory is not an endorsement.

A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study (NCT04565990) · Clinical Trials Directory