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Lumacaftor/Ivacaftor in Children 6-11 Years with Cystic Fibrosis
NCT01897233Phase 3Completed
- Sponsor
- Vertex Pharmaceuticals
- Start
- Jul 2013
- Primary completion
- Oct 2015
- Modality
- Small Molecules
- Countries
- 2
01
Overview
Phase 3, open-label, single-arm trial of lumacaftor and ivacaftor in cystic fibrosis (CF), sponsored by Vertex Pharmaceuticals. Primary endpoints: Observed Plasma Concentration of Lumacaftor and Ivacaftor at Hour 4 Post-dose, Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval at Day 14 and 1 more. Started Jul 2013; status: completed.
02
Drugs
lumacaftorivacaftor
03
Conditions
cystic fibrosis (CF)
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