At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 70 enrolled
Drug / intervention
Ivacaftor +1 moredrug
Likely dose
Ivacaftor 150 milligramfrom 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 Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating Ivacaftor and Placebo for Cystic Fibrosis. Completed, enrolled 70 participants across 31 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited Kingdom, United States
CollaboratorsCystic Fibrosis Foundation
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartJul 2012
Primary CompletionOct 2013
TodayJul 2026
First PostedJun 8, 2012
Enrollment StartJul 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.1 years ago
Interventions
Ivacaftordrug
Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
Placebodrug
Placebo matched to Ivacaftor tablet orally twice daily for 24 weeks.