At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 510 enrolled
Drug / intervention
VX-661 Plus Ivacaftor Combination +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 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 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 VX-661 Plus Ivacaftor Combination, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 510 participants across 74 sites in 12 countries.
Detailed Summary
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedJan 2015
Primary CompletionJan 2017
TodayJul 2026
First PostedJan 27, 2015
Enrollment StartJan 1, 2015
Primary CompletionJan 20, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.4 years ago
Interventions
VX-661 Plus Ivacaftor Combinationdrug
FDC tablet, oral use
Ivacaftordrug
Tablet, oral use
VX-661 Plus Ivacaftor Combination Placebodrug
FDC tablet, oral use
Ivacaftor placebodrug
Tablet, oral use