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NCT02514473 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
NCT02514473: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02514473 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02514473, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
Study 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
Primary Outcome
Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.
Interventions
- DRUG Placebo
- DRUG VX-809
- DRUG VX-770
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT02514473 record still lists
NCT02514473 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02514473 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02514473 about?
NCT02514473 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation". 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
What is the current status of trial NCT02514473?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2015-07. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02514473?
The interventions under investigation include: Placebo (DRUG), VX-809 (DRUG), VX-770 (DRUG).
Who is sponsoring clinical trial NCT02514473?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02514473's enrollment target sits among peer trials
206 1347th of 2000 higher than 651 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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