VX09-809-102 Lumacaftor Alone and Lumacaftor/Ivacaftor in Adult CF

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

• IRAS ID

  142034

• Contact name

  Jane Davies

• Contact email

  j.c.davies@imperial.ac.uk

• Sponsor organisation

  Vertex Pharmaceuticals Incorporated

• Eudract number

  2010-020413-90

• Clinicaltrials.gov Identifier

  NCT01225211

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  13/LO/1700

• Date of REC Opinion

  30 Dec 2013

• REC opinion

  Further Information Favourable Opinion