At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
Ivacaftor +1 moredrug
Likely dose
Ivacaftor 150 mgfrom 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, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted
In Brief
A Phase 2 clinical trial evaluating Ivacaftor and Placebo for Cystic Fibrosis. Completed, enrolled 21 participants across 8 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on at least 1 allele.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United Kingdom, United States
CollaboratorsCystic Fibrosis Foundation
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartJan 2011
Primary CompletionNov 2011
TodayJul 2026
First PostedDec 17, 2010
Enrollment StartJan 1, 2011
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.5 years ago
Interventions
Ivacaftordrug
150 mg tablet, oral use, twice daily every 12 hours (q12h)
Placebodrug
Tablet, oral use, twice daily every 12 hours (q12h)