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NCT02392234 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation
A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT02392234: Completed Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02392234 is a Phase 3 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 248 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02392234, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Conditions Studied
Interventions
- DRUG Ivacaftor
- DRUG VX-661/Ivacaftor
- DRUG Placebo matched to VX-661/ ivacaftor
- DRUG Placebo matched to Ivacaftor
Study Locations (20)
Florida
- - Gainesville
- - Miami
- - Orlando
- - Pensacola
- - Tampa
California
- - Long Beach
- - Oakland
- - Palo Alto
- - Sacramento
Arizona
- - Phoenix
- - Tucson
Colorado
- - Aurora
- - Denver
Illinois
- - Chicago
- - Park Ridge
Alabama
- - Birmingham
Georgia
- - Atlanta
Iowa
- - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
What the finished NCT02392234 record still lists
NCT02392234 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (39% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 4 interventions - of which Ivacaftor is the first listed.
NCT02392234 names 20 study sites across 10 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02392234 about?
NCT02392234 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation". The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual functi...
What is the current status of trial NCT02392234?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 248 participants. The study started on 2015-03. Estimated completion is 2017-02.
What conditions does trial NCT02392234 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02392234?
The interventions under investigation include: Ivacaftor (DRUG), VX-661/Ivacaftor (DRUG), Placebo matched to VX-661/ ivacaftor (DRUG), Placebo matched to Ivacaftor (DRUG).
Who is sponsoring clinical trial NCT02392234?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02392234 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02392234's enrollment target sits among peer trials
248 28th of 169 higher than 142 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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