A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation

Trial Profile

A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2017

At a glance

  • Drugs Ivacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVISION
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 01 Feb 2017 Results of a post-hoc analysis from this and one other study published in the Pediatrics.
    • 08 Oct 2015 According to a Vertex media release, post-hoc analysis of this, STRIVE and PERSIST studies was presented at the 29th Annual North American Cystic Fibrosis Conference
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