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NCT02412111 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT02412111: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02412111 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02412111, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Interventions
- DRUG Ivacaftor
- DRUG Tezacaftor/Ivacaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-09 |
| Phase | Phase 3 |
What the finished NCT02412111 record still lists
NCT02412111 is an interventional study that assigns participants to a tested intervention. The registered 156 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Ivacaftor is the first listed.
NCT02412111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02412111 about?
NCT02412111 is a clinical study titled "A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor". This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinic...
What is the current status of trial NCT02412111?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2015-06. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02412111?
The interventions under investigation include: Ivacaftor (DRUG), Tezacaftor/Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT02412111?
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 NCT02412111's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 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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