A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate 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

Trial Profile

A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate 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

Completed
Phase of Trial: Phase II

Latest Information Update: 09 Oct 2015

At a glance

  • Drugs Ivacaftor (Primary) ; Ivacaftor/lumacaftor (Primary) ; Lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 02 Oct 2015 Treatment arms changed from 6 to 10. End points related to sweat chloride has been added as reported by ClinicalTrials.gov record.
    • 19 Aug 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 29 Jul 2014 Primary endpoint has not been met (percent-predicted forced expiratory volume in 1 second) according to a Vertex Pharmaceuticals media release.
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