Back to results

A Study of Selexipag in Participants Who Participated in a Previous Selexipag Study (SOMBRERO)

Primary Purpose

Hypertension, Pulmonary

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Selexipag

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Republican Scientific-Practical Center ''Cardiology''
Minsk Regional Clinical Hospital
Sanjivani Hospitals
Apollo Hospitals
Gachon University Gil Medical Center
Samsung Medical Center
The Catholic University of Korea Seoul St. Mary's Hospital
Institutul de pneumoftiziologie Marius Nasta
Kaohsiung Veterans General Hospital
National Taiwan University Hospital
Municipal Inst. Of Dnipropetrovsk Region. Council
Health Care Municipal Institution City Clinical Hospital #13
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selexipag

Arm Description

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

Outcomes

Primary Outcome Measures

Frequency of Adverse Events (AEs)

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention.

Frequency of AEs Leading to Premature Discontinuation of Selexipag

Frequency of Serious Adverse Events (SAEs)

An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product or medically important.

Frequency of Death

Frequency of death will be reported.

Number of Pregnancies with Maternal Exposure to Selexipag

Number of pregnancies with maternal exposure to selexipag will be reported.

Secondary Outcome Measures

Full Information

NCT ID

NCT04565990

First Posted

September 22, 2020

Last Updated

October 10, 2023

Sponsor

Actelion

1. Study Identification

Unique Protocol Identification Number

NCT04565990

Brief Title

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

Acronym

SOMBRERO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

September 18, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Selexipag

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Selexipag

Other Intervention Name(s)

JNJ-67896049, ACT-293987

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of Adverse Events (AEs)

Description

Time Frame