A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.



Sponsor:   Bayer


Sommario: To provide riociguat therapy to eligible patients with PAH originating from
Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or
recently treated in these trials until lack of patient benefit as assessed by
investigator, or commercial availability and reimbursement.




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 4




TRATTAMENTO

  
    
  






OBIETTIVO PRIMARIO


  
  • Misura: Number of patients with treatment-emergent adverse events (TEAEs) as measure of safety and tolerability
  • Tempo: Up to approx. 3 years
  • Descrizione: 






CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    Inclusion Criteria:

  -  Patients diagnosed with Pulmonary Arterial Hypertension (PAH) participating or
     having participated in the Bayer-sponsored studies 12935, 16719 or 18588, who have
     completed the main study phase and are still being treated with riociguat (either
     while still being on treatment with the respective study drug or by commercial means
     with Adempas) and who, in the opinion of the investigator, are expected to continue
     to have an overall positive benefit/risk from continuing treatment.

  -  Women and men of reproductive potential must agree to use adequate contraception
     when sexually active. This applies for the time period between signing of the
     informed consent form and 30 days after the last administration of study drug.

Exclusion Criteria:

  -  Ongoing serious adverse event (SAE) from originating study that is assessed as
     related to riociguat

  -  Pregnant women or breast-feeding women

  -  Any contra-indication to Adempas treatment listed in the BAY63-2521 / Riociguat
     Investigators's Brochure

  -  Concomitant participation in another clinical study with the study drug

  -  Patients with pulmonary hypertension associated with idiopathic interstitial
     pneumonia (PH-IIP)
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: N/A






LUOGO