Study of safety of QAW039 in patients (≥ 12 yrs) with asthma inadequately controlled on standard-of-care asthma therapy

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-001560-11

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

Treatment Period 1 (double-blind, 52-week treatment period): In patients with moderate-to-severe asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: -treatment emergent adverse events (AEs); -treatment emergent serious adverse events (SAEs); and -study discontinuations due to treatment emergent AEs. Treatment Period 1 and Treatment Period 2 combined: In patients with moderate-to-severe-asthma receiving SoC asthma therapy, to evaluate the long-term safety of QAW039 (150 mg once daily and 450 mg once daily), compared with placebo, as assessed by: -treatment emergent AEs -treatment emergent SAEs; and -study discontinuations due to treatment emergent AEs.


Critère d'inclusion

  • Asthma