Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03942211
Status:
TERMINATED
Last Update Posted:
2024-05-08
First Post:
2019-05-07
Brief Title:
A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension SAPH to Assess the Efficacy and Safety of Oral Selexipag
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension SAPH to Assess the Efficacy and Safety of Oral Selexipag
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor decided to prematurely terminate the study due to the lower-than-expected recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPHINX
Brief Summary:
Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension PH called pulmonary arterial hypertension PAH The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension SAPH
Detailed Description:
Pulmonary hypertension PH is a pathophysiological disorder that may involve multiple clinical conditions and can complicate several cardiovascular and respiratory diseases Sarcoidosis is a multisystemic disorder that is characterized by non-caseating granulomas which are present in multiple tissues particularly in the lung and lymphatic system Severe untreated pulmonary hypertension PH carries a poor prognosis and is associated with higher mortality in participants with interstitial lung diseases and sarcoidosis While there is no approved treatment for SAPH PH-specific treatments are frequently used Selexipag is a selective orally available and long-acting non-prostanoid agonist of the prostacyclin receptor prostacyclin IP receptor for the treatment of patients with PAH The rationale for this study is based on the unmet medical need for new therapeutic options for patients with SAPH and is supported by the established efficacy and safety of selexipag in the PAH indication the shared pathomechanism between SAPH and PAH and the available data on the efficacy and safety of PH-specific therapies in SAPH This study consists of screening period main observation period and double blind extension period and safety follow-up period The duration of individual participation in the study will be different for each individual participant between approximately 15 months and up to approximately 35 years and will depend on the time of each participants individual date of entering the study and the total recruitment time The efficacy assessments include right heart catheterization RHC assessment of exercise capacity dyspnea pulmonary function tests etc Safety and tolerability will be evaluated throughout the study and includes review of concomitant medications and adverse events AEs clinical laboratory tests 12-lead electrocardiogram ECG vital signs physical examination and pregnancy testing
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 |
|---|---|---|---|
| 2018-004887-74 | EUDRACT_NUMBER | None | None |