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



Sponsor:   Actelion


Sommario: 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.




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 3




TRATTAMENTO

  
    
  
  • Selexipag
  • Placebo
    • 






OBIETTIVO PRIMARIO


  
  • Misura: Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
  • Tempo: Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20
  • Descrizione: Change from baseline in PVR at Week 20 was reported. PVR was measured by accessing the
vessel either from right heart catheterization or left heart catheterization, if
required. Change from baseline in PVR was measured as percent ratio of post treatment
value (Week 20) to pre-treatment value (baseline).






CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    Main Inclusion Criteria:

  -  Signed and dated informed consent form

  -  Male and female participants from greater than or equal to (>) 18 (or the legal age
     of consent in the jurisdiction in which the study is taking place) and less then or
     equal to (<=85) years old at Screening (Visit 1)

  -  With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or
     persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon
     pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication
     committee

  -  With pulmonary hypertension (PH) in WHO FC I-IV.

  -  Participant able to perform the 6-minute walk test (6MWT) with a minimum distance of
     100 m and a maximum distance of 450 m at screening visit.

  -  Women of childbearing potential must have a negative pregnancy test at screening and
     randomization and must agree to undertake monthly urine pregnancy tests, and to use
     a reliable method of birth control from screening visit up to at least 30 days after
     study treatment discontinuation. If a hormonal contraceptive is chosen it must be
     taken for at least 1 month prior to randomization.

Main Exclusion Criteria:

  -  Planned or current treatment with another investigational treatment up to 3 months
     prior to randomization.

  -  Any known factor or disease that might interfere with treatment compliance, study
     conduct, or interpretation of the results, such as drug or alcohol dependence or
     psychiatric disease.

  -  Known concomitant life-threatening disease with a life expectancy < 12 months.

  -  Planned balloon pulmonary angioplasty within 26 weeks after randomization.

  -  Change in dose or initiation of new PH-specific therapy within 90 days prior to the
     baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic
     cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic
     cohort

  -  Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e.,
     treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e.,
     selexipag) within 90 days prior to randomization (visit 2) except those given at
     vasodilator testing during RHC

  -  Change in dose or initiation of new diuretics and/or calcium channel blockers within
     1 week prior to baseline RHC (and LHC, if needed)

  -  Any co-morbid condition that may influence the ability to perform a reliable and
     reproducible 6MWT, including use of walking aids (cane, walker, etc).

  -  Any other criteria as per selexipag Summary of Product Characteristics (SmPC).

  -  Exclusion criteria related to comorbidities: severe coronary heart disease or
     unstable angina as assessed by the investigator; mocardial infarction within the
     last 6 months prior to or during Screening; decompensated cardiac failure if not
     under close supervision; severe arrhythmias as assessed by the investigator;
     cerebrovascular events (example transient ischemic attack, stroke) within the last 3
     months prior to or during screening; congenital or acquired valvular defects with
     clinically relevant myocardial function disorders not related to pulmonary
     hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: 85 Years






LUOGO


  
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna	3181928, 40138
Fondazione IRCCS Policlinico San Matteo
Pavia	3171366, 27100
Policlinico Umberto I
Roma	8957247, 00161
Ospedale di Cattinara - Struttura complessa di Pneumologia
Trieste	3165185, 34149