Trial intelligence / Profile preview

Phase 3 study of lumacaftor + ivacaftor in cystic fibrosis with homozygous F508del mutation

2012-003989-40Phase 3Completed

Sponsor
Vertex Pharmaceuticals
Start
Mar 2013
Modality
Small Molecules
Countries
1
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Overview

Phase 3, randomised, double-blind trial in cystic fibrosis (CF) comparing lumacaftor + ivacaftor with placebo (2 arms). Primary endpoint: Absolute change in percent predicted forced expiratory volume in 1 second (FEV1) from baseline at Week 24. Started Mar 2013; status: completed.

02

Drugs

lumacaftorivacaftor
03

Conditions

cystic fibrosis (CF)

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