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Completed

NCT Number: NCT04565990

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

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Minsk Regional Clinical Hospital, Minsk, Belarus

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selexipag

Drug

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

Other names: JNJ-67896049, ACT-293987

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

    Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days. Data includes all TEAEs irrespective of whether they were serious or non-serious.

  2. Number of Participants With TEAEs Leading to Premature Discontinuation of Selexipag

    Time frame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

    Number of participants with TEAEs leading to premature discontinuation of selexipag were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as AEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days.

  3. Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

    Number of participants with TESAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TESAEs were defined as TSAEs occurring at or after the initial administration of study intervention through the day of last dose plus 3 days.

  4. Number of Participants With Treatment-emergent Deaths

    Time frame: From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

    Number of participants with treatment-emergent deaths during the study were reported.

  5. Number of Pregnant Females With Maternal Exposure to Selexipag

    Time frame: From Day 1 up to 30 days after last dose of drug (up to 29 months)

    Number of pregnant females with maternal exposure to selexipag were reported.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

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

Acronym: SOMBRERO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2020
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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