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

NCT ID: NCT04565990

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2023-11-10

Brief 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

Hypertension, Pulmonary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selexipag

Participants will receive selexipag tablets twice daily with the dose strength corresponding to their individual maximum tolerated dose (iMTD) from the parent study.

Group Type: EXPERIMENTAL

Selexipag

Intervention Type: DRUG

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

Interventions

Selexipag

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

Intervention Type: DRUG

Other Intervention Names

JNJ-67896049; ACT-293987

Eligibility Criteria

Inclusion Criteria

• Treated with selexipag at the end of a parent study and: a) the parent study has established efficacy with a favorable benefit/risk profile for the indication under investigation; b) participant may continue to benefit from treatment with selexipag; c) has completed the end of treatment (EOT) visit of the parent study; d) no alternative means of access to selexipag have been identified
• Women of childbearing potential must use an acceptable method of contraception throughout the study and until at least 1 month following the last dose of study intervention
• Women of childbearing potential must have a negative urine (or serum if applicable) pregnancy test at screening on Day 1 or at the last visit of the parent study
• Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria

• Suspected or known pulmonary veno-occlusive disease
• Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
• Interruption of study intervention for more than 14 days since the last dose of study intervention taken in the parent study
• Female participant being pregnant, or breastfeeding, or planning to become pregnant at the time of screening and while enrolled in this study
• Uncontrolled thyroid disease
• Known and documented severe hepatic impairment, example, Child-Pugh Class C
• Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention: a) treatment with a strong CYP 2C8 inhibitor (example, gemfibrozil); b) treatment with oral prostacyclin analogs (example, beraprost, treprostinil) since the last dose of study intervention taken in the parent study; c) any investigational treatment other than selexipag
• Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure if not under close medical supervision, severe arrhythmia, cerebrovascular events (example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Actelion Clinical Trial

Role: STUDY_DIRECTOR

Actelion

Locations

The Republican Scientific-Practical Center ''Cardiology''

Minsk, , Belarus

Minsk Regional Clinical Hospital

Minsk, , Belarus

Sanjivani Hospitals

Ahmedabad, , India

Apollo Hospitals

Chennai, , India

Institutul de pneumoftiziologie Marius Nasta

Bucharest, , Romania

Gachon University Gil Medical Center

Incheon, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, , South Korea

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Municipal Inst. Of Dnipropetrovsk Region. Council

Dnipro, , Ukraine

Health Care Municipal Institution City Clinical Hospital #13

Kharkiv, , Ukraine

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Kyiv, , Ukraine

Countries

Belarus; India; Romania; South Korea; Taiwan; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-000475-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67896049PUH3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108892

Identifier Type: -

Identifier Source: org_study_id