At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 312 enrolled
Drug / intervention
Lumacaftor +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Lumacaftor, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 312 participants across 55 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, France, Germany, New Zealand, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedOct 2010
Primary CompletionApr 2014
TodayJul 2026
First PostedOct 20, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.7 years ago
Interventions
Lumacaftordrug
Tablet
Ivacaftordrug
Tablet.
Lumacaftor Placebodrug
Matching placebo tablet.
Ivacaftor Placebodrug
Matching placebo tablet.