A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment
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 persistent/recurrent CTEPH.
Timeline
- Start
- 2019-01-23
- Primary completion
- 2022-06-07
- Completion
- 2022-06-07
Outcome
Missed primary endpoint
Stopped: “The study did not demonstrate efficacy on the primary endpoint, PVR vs. placebo at wk 20 at a planned interim analysis.”
registry analysis (superiority test); Double-blind Period: Placebo vs Double-blind Period: Selexipag; p = 0.412; Ratio of Geometric LS mean 0.95 (95% CI 0.84 to 1.07); ANCOVA NCT03689244 ↗
paper The independent data monitoring committee recommended to stop the study for futility as no statistically significant difference was observed for the primary end-point PMID 39326918 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selexipag | Small molecule | 200 ug | Oral |
| Subject | Selexipag | Small molecule | 400 ug | Oral |
| Subject | Selexipag | Small molecule | 600 ug | Oral |
| Subject | Selexipag | Small molecule | 800 ug | Oral |
| Subject | Selexipag | Small molecule | 1000 ug | Oral |
| Subject | Selexipag | Small molecule | 1200 ug | Oral |
| Subject | Selexipag | Small molecule | 1400 ug | Oral |
| Subject | Selexipag | Small molecule | 1600 ug | Oral |