A Study of Selexipag in Participants Who Participated in... | NCT04565990

NCT04565990

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2020-000475-21	EudraCT Number
67896049PUH3001	Other Identifier	Actelion

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Selexipag	Experimental	Participants will receive selexipag tablets twice daily with the dose strength corresponding to their individual maximum tolerated dose (iMTD) from the parent study.	Drug: Selexipag

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selexipag	Drug	Selexipag tablets will be administered orally at all dose strengths (200, 400, 600, 800, 1000, 1200, 1400 and 1600 microgram) twice daily.	Selexipag

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	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.	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	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.	From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)	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.	From Day 1 up to 3 days after last dose of drug (up to 28 months 3 days)

Eligibility Module

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

Name	Affiliation	Role
Actelion Clinical Trial	Actelion	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Republican Scientific-Practical Center ''Cardiology''		Minsk		220036	Belarus
Minsk Regional Clinical Hospital

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms [mcg] selexipag tablet orally twice daily [bid]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms [mcg] selexipag tablet orally twice daily [bid]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

Safety analysis set included all participants who received at least 1 dose of study intervention in this study..

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Selexipag

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Selexipag	Participants with pulmonary arterial hypertension (PAH) who completed the parent study AC-065A302 (NCT01106014) continued treatment with selexipag in this study (200 to 1600 micrograms [mcg] selexipag tablet orally twice daily [bid]) from Day 1 up to 28 months with the same individual maximum tolerated dose (iMTD) that they were taking at the end of their parent study. Eligible participants were then followed up for safety up to 30 days after the last dose of selexipag.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 26, 2021	Oct 28, 2024	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Oct 27, 2023	Oct 8, 2024	SAP_001.pdf

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases