CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 206 enrolled
Drug / intervention
VX-809 +2 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.

Search/NCT02514473
NCT02514473Phase 3Completed
CompareCT.gov

A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Aug 3, 2015·Updated Oct 23, 2017

In Brief

A Phase 3 clinical trial evaluating VX-809, Placebo, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 206 participants across 53 sites in 9 countries.

Detailed Summary

To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 3, 2015
Enrollment StartJul 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.9 years ago

Interventions

VX-809drug

Placebodrug

VX-770drug