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 Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension
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 Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension
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.
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.
Main Inclusion Criteria:
Main Exclusion Criteria:
Los Angeles, California 90033, United States
Albuquerque, New Mexico 87131, United States
Plano, Texas 75093, United States
Caba, 1199ABB, Argentina
Caba, C1048AAN, Argentina
Caba, C1093AAS, Argentina
CABA, C1155AHD, Argentina
CABA, C1280AEB, Argentina
Belo Horizonte, 30441-070, Brazil
Fortaleza, 60840-285, Brazil
Porto Alegre, 90610-000, Brazil
São Paulo, 04037-003, Brazil
Beijing, 100730, China
Prague, 128 08, Czechia
Dresden, 01307, Germany
Giessen, 35392, Germany
Greifswald, 17475, Germany
Hanover, 30625, Germany
Homburg/Saar, 66421, Germany
Leipzig, 04103, Germany
Szeged, 6720, Hungary
Novosibirsk, 630055, Russia
Saint Petersburg, 197341, Russia
Kartal Istanbul, 34865, Turkey (Türkiye)
Kyiv, 02000, Ukraine
Kyiv, 03038, Ukraine
Glasgow, G81 4DY, United Kingdom