A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)
Phase of Trial: Phase III
Latest Information Update: 18 Jun 2018
At a glance
- Drugs Ivacaftor/tezacaftor (Primary)
- Indications Cystic fibrosis
- Focus Registrational; Therapeutic Use
- Sponsors Vertex Pharmaceuticals
- 10 Jun 2017 Biomarkers information updated
- 13 Sep 2016 This trial was completed in Germany (end date: 12-08-2016), according to European Clinical Trials Database.
- 13 Sep 2016 This trial was completed in Spain (end date: 27-05-2016), according European Clinical Trials Database.