VX12-809-104 Lumacaftor + Ivacaftor in Cystic Fibrosis

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

• IRAS ID

  127851

• Contact name

  Jane Davies

• Contact email

  j.c.davies@imperial.ac.uk

• Sponsor organisation

  Vertex Pharmaceuticals Incorporated

• Eudract number

  2012-003990-24

• Clinicaltrials.gov Identifier

  NCT01807949

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  13/SC/0171

• Date of REC Opinion

  10 Jun 2013

• REC opinion

  Further Information Favourable Opinion