Ignite Creation Date:
2024-05-06 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03689244
Status:
TERMINATED
Last Update Posted:
2024-06-21
First Post:
2018-09-27
Brief Title:
A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or PersistentRecurrent After Surgery andor Interventional Treatment
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Parallel-group Group-sequential Adaptive Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or PersistentRecurrent After Surgical andor Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study did not demonstrate efficacy on the primary endpoint PVR vs placebo at wk 20 at a planned interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SELECT
Brief Summary:
Selexipag is available in many countries for the treatment of pulmonary arterial hypertension PAH Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension CTEPH and the observed efficacy of other PAH medicines in CTEPH it is believed that selexipag could benefit to patients with CTEPH This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistentrecurrent CTEPH
Detailed Description:
Participants will be recruited in two sequential cohorts approximately the first 90 randomized participants will undergo a right heart catheterization RHC and left heart catheterization LHC if needed with measurement of pulmonary vascular resistance PVR at Week 20 and will constitute the hemodynamic cohort the remaining participants will constitute the non-hemodynamic cohort who do not require a post-baseline hemodynamic assessment They will undergo the same overall study assessments as the hemodynamic cohort excepted for RHC at Week 20
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 |
|---|---|---|---|
| 2018-002823-41 | EUDRACT_NUMBER | None | None |