clinical trial · NCT02070744
Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion
Vertex Pharmaceuticals Incorporated·phase2·completed·n = 40
Cystic FibrosisVX-661IvacaftorPlacebo matched to VX-661Placebo matched to Ivacaftor
brief 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
started
Mar 1, 2014
primary completion
May 27, 2016
completion
May 27, 2016
last updated
Sep 24, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol