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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 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 156 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02412111
The ClinicalTrials.gov registry entry for NCT02412111 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ivacaftor is the first listed.
NCT02412111 reports 0 study locations.
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.
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