Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04175600
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2019-11-08
Brief Title:
A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Randomized Multicenter Double-Blind Placebo-Controlled Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged 2 to 18 Years With Pulmonary Arterial Hypertension
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SALTO
Brief Summary:
The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension PAH in comparison to placebo
Detailed Description:
Pediatric PAH is a rare and progressive disorder associated with considerable morbidity and mortality Given the significant medical need to develop treatments in children with PAH further clinical studies in the pediatric population are therefore needed to provide more data for the management of PAH in children Selexipag JNJ-67896049 is an orally available selective and long-acting non-prostanoid agonist of the prostacyclin receptor approved and commercially available for the treatment of adult participants with PAH Selexipag and its metabolite possess anti-fibrotic anti-proliferative and anti-thrombotic properties Currently no medicines targeting prostacyclin pathway are approved for pediatric use in PAH An effective and orally available therapy acting on the prostacyclin receptor such as selexipag introduced at medically appropriate stage of PAH disease and primarily in combination with current first-line oral PAH-specific medicines in participants in need of additional therapy because of insufficient disease control would represents a major advance to the therapeutic management of PAH pediatric participants This study consists of a screening period of up to 6 weeks and a double-blind treatment period including up-titration and maintenance periods followed by a 3-year open-label extension period OLEP and a 30-day safety follow-up period that occurs after the last dose of study intervention either double-blind or open-label Safety pharmacokinetic and efficacy assessments will be performed during the study An Independent Data Monitoring Committee IDMC will be established to monitor data on an ongoing basis to review interim data and to ensure the continuing safety of the participants enrolled in this study The approximate duration of the study is 8 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501012-34-00 | REGISTRY | EUCT number | None |
| 2019-002817-21 | EUDRACT_NUMBER | None | None |
| AC-065A310 | OTHER | None | None |