At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 559 enrolled
Drug / intervention
Lumacaftor Plus Ivacaftor Combination +2 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 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
In Brief
A Phase 3 clinical trial evaluating Lumacaftor Plus Ivacaftor Combination, Ivacaftor, and 1 other intervention for Cystic Fibrosis, Homozygous for the F508del CFTR Mutation. Completed, enrolled 559 participants across 89 sites in 11 countries.
Detailed Summary
The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Czechia, France, Germany, Ireland, Italy, Netherlands, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartMay 2013
Primary CompletionApr 2014
TodayJul 2026
First PostedMar 8, 2013
Enrollment StartMay 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.3 years ago
Interventions
Lumacaftor Plus Ivacaftor Combinationdrug
Fixed dose combination tablet
Ivacaftordrug
Film-coated tablet
Placebodrug
Matching placebo tablet