At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 194 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, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
In Brief
A Phase 2 clinical trial evaluating VX-661, Ivacaftor, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 194 participants across 36 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) effects of VX-661 alone and when coadministered with ivacaftor in participants with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del-CFTR mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, Germany, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionMar 2014
TodayJul 2026
First PostedFeb 13, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.4 years ago
Interventions
VX-661drug
Ivacaftordrug
Placebo matched to VX-661drug
Placebo matched to ivacaftordrug