At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
VX-661 +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, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension
In Brief
A Phase 2 clinical trial evaluating VX-661, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 40 participants across 23 sites.
Detailed Summary
The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionMay 2016
TodayJul 2026
First PostedFeb 25, 2014
Enrollment StartMar 1, 2014
Primary CompletionMay 27, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.4 years ago
Interventions
VX-661drug
Tablet, oral use
Ivacaftordrug
Film coated tablet, oral use
Placebo matched to VX-661drug
Tablet, oral use
Placebo matched to Ivacaftordrug
Film coated tablet, oral use